Kep Menperindag 167 MPP Kep 5 1997 English Version

7/28/2019 Kep Menperindag 167 MPP Kep 5 1997 English Version

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AUTHORIZED TRANSLATION

ANNOUNCEMENT/GOVERNMENT REGULATION

TECHNICAL REQUIREMENTS OFMINERAL WATER INDUSTRY AND TRADE

(Decree of the Minister of Industry and Trade of

the Republic of Indonesia No. 167/MPP/Kep/5/1997

dated May 28, 1997)

THE MINISTER OF INDUSTRY AND TRADE OF

THE REPUBLIC OF INDONESIA,

Considering:

a. whereas to secure Mineral Water quality (AMDK) asprescr ibed in Na tional Quali ty Standard for Minera l Water (SNI-AMDK) and increase competitiveness as well as support fair

competition, it is necessary to stipulate Technical Requirements

of Mineral Water Industry and Trade.

b. whereas in this respect, it is considered necessary to issueDecree of the Minister of Industry and Trade.

In view of:

1. Law of the Republic of Indonesia Number 5 of 1984 (BN No. 4079pp . 5B-13B) regarding Industry (S tate Gazet te of 1984 No. 22,

Supplement to State Gazette No. 3274);2. Law of the Republic of Indonesia Number 23 of 1992 (BN No.

5321 pp. 5B-7B seq.) regarding Health (State Gazette of 1992 No.

100, Supplement to State Gazette No. 3495);

3. Law of the Republic of Indonesia Number 7 of 1996 (BN No. 5934pp . 20B-25B seq .) regarding Food (S tate Gazett e of 1996 No. 99 ,

Supplement to State Gazette No. 3656);

4. Government Regulation of the Republic of Indonesia Number 17of 1986 (BN No. 4338 pp. 12B-13B) regarding Authority to

Regulate, Promote and Development Industry (State Gazette of

1986 No. 23, Supplement to State Gazette No. 3330);

5. Government Regulation of the Republic of Indonesia Number 15of 1991 (BN No. 5089 pp. 3B-8B) regarding Indonesian National

Standard (State Gazette of 1991 No. 19, Supplement to State

Gazette No. 3434);

6. Government Regulation of the Republic of Indonesia Number 13of 1991 (BN No. 5713 pp. 18B-20B) regarding Industrial Permit

(State Gazette of 1995 No. 25, Supplement to State Gazette No.

3596);

7. Decree of the President of the Republic of Indonesia Number 12of 1991 (BN No. 5090 pp. 4B-7B) regarding Preparation,

Application and Supervision of Indonesian National Standard;


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8. Decree of the President of the Republic of Indonesia Number 2 of1996 (BN No. 5807 pp. 1B-2B) regarding Amendment to Decree

of the President of Number 15 of 1984 (BN No. 4064 pp. 9B-12B

seq.) regarding Organization Structure of Ministries as already

amended twenty five times recently by virtue of Decree of the

President No. 61 of 1995 (BN No. 5759 pp. 3B);9. Decree of the Minister of Industry No. 120/M/SK/10/1990 (BN

No. 5075 pp. 2B-3B) regard ing Appl icat ion of Indonesian

Industrial Standard (SII) and Compulsory SII Labelling on

Mineral Water (AMDK);

10. Decree of the Minister of Industry No. 250/M/SK/10/1994 (BNNo. 5710 pp. 1B-17B) regarding Technica l Guidelines on Draf ting

of Environmental Impacts Control in Industrial Sector;

11. Decree of the Minister of Industry No. 148/M/SK/7/1995 (BN No.5745 pp. 4B-7B) regarding Designation of Industrial Types and

Commodities Not Harming Environment nor Over-exploiting

Natural Resources;12. Decree of the Minister of Industry No. 150/M/SK/7/1995 (BN No.

5747 pp. 9B-12B seq.) regarding Procedure for Industrial and

Expansion Permits;

13 . Decree of the Minister of Industry and Trade Number29/MPP/SK/2/1996 jo. No. 92/MPP/Kep/4/1996 regarding

Organization and Work Procedure of the Ministry of Industry and

Trade;

14. Decree of the Minister of Industry and Trade No.108/MPP/Kep/5/1996 (BN No. 5880 pp. 11B-14B) regarding

Quality Standardization, Certification and Supervision within the

Ministry of Industry and Trade.

HAS DECIDED:

To stipulate:

DECREE OF THE MINISTER OF INDUSTRY AND TRADE

REGARDING TECHNICAL REQUIREMENTS OF MINERAL WATER

INDUSTRY AND TRADE.

CHAPTER I

GENERALArticle 1

In this Decree by:

1. Mineral Water (AMDK) we mean treated/processed, and safelypacked wa ter in order to be potable.

2. Raw water we mean raw material processed to Mineral Water(AMDK) originating from aquifer, natural spring on the surface

and/or Water Supply Company (PDAM) which takes untreated

water from springs.

3. Production process we mean raw water treatment in phases toproduce Mineral Water (AMDK).


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4. Mineral Water production machines/equipment we mean those touse in production process.

5. Mineral Water Laboratory Test Facility we mean any equipmentincluding reagents to assay quality in production process and

products thereof .

6. Mineral Water quality standard we mean quality standardstipulated by technical agency after approval from NationalStandardization Board (DSN).

7. Mark we mean mark in terms of drawing, name, word(s),character(s), number(s), color composition or combination thereof

with distinctive nature and used in goods or services trade.

8. Label we mean any indication or explanation on food in terms ofdrawing, or words or combination thereof, or other wise included

in food, or attached to or being a part of pack/container.

9. Pack/container we mean any products to contain or wrap food indirect contact with content, including lids thereof.

10. MD/ML Number we mean registration number and code issuedwith the Ministry of Health of the Republic of Indonesia for

local/imported food products.

11. Expiry date we mean end of period during which food quality isguaranteed provided it is stored as per instruction.

12. Production Code we mean production date and shift order in termsof numerals and or characters or otherwise indicating production

history.

13. Indonesian National Standard (SNI) we mean standard which isstipulated and applied by the Minister after approval from DSN

and nationally applicable in Indonesia.

14. SNI mark shall we mean be certification mark affixed on product,pack /con taine r or label indicating that the product compl ies with

SNI requirements.

15. Charge for making we mean agreement between producer andconsumer in which the producer shall produce and product with

brand as presc ribed by consumer.

16. Food grade substance we mean any substance which does not giverise any toxic, odor or taste, unabsorbtive, resistant against rust,

leaching and redesinfection.

17. Minister we mean be the Minist er of Industry and Trade.CHAPTER II

PRODUCTION PROCESS, PRODUCTION MACHINE/EQUIPMENT,

RAW WATER AND PLANT SITE

Article 2

(1) Mineral Water Company shall fulfill SNI and technicalrequirements as contained in Appendices I and II hereto.

(2 ) Each Mineral Water Company shall at least have mineral waterquality supervision laboratory with equipment as provided in

Appendix I hereto.


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(3 ) Quality control and test during production process shall be madeeach time to secure quality as required by the prevailing

requirements of National Industrial Standard of Mineral Water

(SNI AMDK).

(4 ) Product quality test shall be made at least semi-annually pursuantto the prevailing SNI AMDK (Mineral Water) and the resultthereof shall be reported to authorities issuing Industrial Operation

Permit or Certificate of Industrial Registration.

Article 3

Mineral Water Company shall have documents pertaining to

quality control and product quality test and they shall be kept for at

least for 2 (two) years.

Article 4

Each Mineral Water Company shall have machines/equipment

with installed capacity per shift of at least 10 (ten) million liters peryear.

Article 5

(1) Raw water for Mineral Water shall be clear, clean and chlorinefree.

(2 ) Raw water to process shall be taken from legal spring, it beingunderstood that the Mineral Water company shall be equipped with

Permit (SIP) and Water Recovery Permit (SIPA) issued by Mines

Office, and or certificate of cooperation or raw material acquisition

from local Water Supply Company.

(3 ) Sources of raw water from underground including springs shall besubject to continuous conservation and monitoring pursuant to the

prevailing legisla tion.

(4 ) Water from Local Water Supply Company (PDAM) which can beused as raw water shall originate from springs and be unprocessed.

(5 ) Raw water quality shall be periodically monitored by laboratorytest at least once quarterly.

(6 ) Sources of raw water shall be from safe location of at least 500 maway from source of contamination.

(7 ) Raw water transportation from source location to Mineral Waterplant sha ll comply wi th th e standard as re ferred to in Appendices Iand II thereto.

Article 6

Mineral Water Plant shall be situated at designated area pursuant

to spatial layout (RUTR) and/or close to terrestrial natural spring.

CHAPTER III

QUALITY

Article 7


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(1 ) The Mineral Water shall fulfill prevailing requirements of SNIAMDK (National Standard of Mineral Water).

(2 ) Any one alleging/finding Mineral Water of quality lower than SNIcan file his report/complaint to Regional Office of the Ministry of

Industry and Trade or Office of the Ministry of Industry and

Trade.(3 ) After receipt of report/complaint, the relevant Official shall make

an inspection.

(4 ) In case the inspection as referred to in paragraph (3) reveals anybreach he reof , the relevant competent Offic ial sha ll wi thin not

later than 7 (seven) working days issue suspension of production.

(5) The suspension can be revoked and the company can resumeproduction af te r ful fi llment of requi rements herein.

CHAPTER IV

CONTAINER

Article 8

(1) Container of Mineral Water made of Poly Etilene (PE),Poliprophilene (PP), Poly Etilene Tereftalate (PET) or Poly Vinyl

Chloride (PVC) shall be of food grade and disposable.

(2 ) Container of Mineral Water made of Poly Carbonate (PC) or glassshall fulfill hygienic requirements and be of food grade, washable

and non-disposable.

CHAPTER V

LABEL

Article 9

(1) Label shall comply with the prevailing legislation.(2 ) Each label shall at least include:

- Type of product: Mineral Water- Name and address of producer- Ne t volume in metric system- Brand/trademark- Production code- Registration Number from the Ministry of Health of the

Republic of Indonesia- Prevailing SNI AMDK number- Expiry date.

CHAPTER VI

MARKETING

Article 10


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(1 ) Domestic and imported Mineral Water which is distributed andmarketed shall:

- have label as referred to in Article 9.- have intact seal.- not be expired.- be contaminant free.(2 ) Imported Rural Water which is distributed or marketed shall meetSNI AMDK standard based on test result of accredited domestic

assay institution.

(3 ) Expense of test as referred to in paragraph (2) and sampling shallbe borne by the impor te r.

(4 ) No Mineral Water fai ling to fu lf il l requi rements hereof shall bedistributed.

(5 ) Distribution or marketing prohibition of Mineral Water shall bemade by the Director General of Domestic Trade by issuing

suspension of distribution.

(6 ) Product recall and destruction shall be made in not later than 2(two) weeks after receipt of suspension of distribution.

(7 ) No repackaging of opened fin ished con tainer of Mineral Wate r forredistribution shall be made.

(8 ) No Mineral Water company sha ll make charge of making wi thMineral Water producer and non Mineral Water producing

customers.

(9 ) No Mineral Water Test product shall be distr ibuted.CHAPTER VII

SUPERVISION

Article 11

Supervision of plant site, raw water, production process,

machine/equipment, product quality, and distributed product shall be

made at least semi annually or at anytime when needed.

Article 12

(1 ) The supervision as referred to in Article 11, shall be made by theDirectorate General of Agricultural and Forestry Produce Industry,

Regional Office/Local Office of the Ministry of Industry and

Trade and assisted by the relevant Government Agencies pursuantto their respective competence.

(2 ) Expenses of supervision as referred to in paragraph (1) shall becharged to budget of the Ministry of Industry and Trade.

(3 ) Finding of supervision as referred to in paragraph (1) andoccurring deviations shall be immediately reported to competent

authorities issuing Industrial Permit or Industrial Registration

Certificate for follow-up by making inspection as referred to in

article 7 paragraphs (4) and (5) hereof.

CHAPTER VIII


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SANCTIONS

Article 13

Any Mineral Water company/trader/importer failing to fulfill

requirements as referred to article 2 paragraphs (1) and (2), article 7

paragraph (1 ), art icl es 8 and 10 sha ll be sanc tioned by revocation ofIndustrial Permit and or Operation Permit or Importer Identification

Certificate.

Article 14

(1) Any Mineral Water company operating without fulfillingrequirements as referred to in Article 7 (1) shall be subjected to

criminal sanctions as referred to in Law Number 5 of 1984

regarding Industry, Law Number 23 of 1992 regarding Health and

Law Number 7 of 1996 regarding Food.

(2) Penal procedure as referred to in paragraph (1) shall be enforcedpursuant to the prevail ing legisl at ion.

CHAPTER IX

MISCELLANY

Article 15

Any Mineral Water companies operating and possessing

Industrial Registration Certificate but not yet fulfilling requirements as

referred to in Article 2 paragraphs (1) and (2), and other requirements

herein shall adjust themselves within 6 (six) months as of the issue

hereof.

Article 16

(1) No Mineral Water fa iling to fu lf il l technical requi rements asprov ided herein and preva iling quality standard of SNI AMDK

shall be produced.

(2 ) The suspension of production shall be issued by authoritiesissuing Industrial Permit or Industrial Registration Certificate.

(3 ) The cessation of production due to failure to fulfill technicalrequirements shall be made in not later than 2 (two) weeks as of

the issue of suspension of production.

(4 ) Cessation of production of Mineral Water failing to fulfill qualityrequirements in accordance with the prevailing SNI AMDK shallbe effec tive as of the issue of suspension .

Article 17

(1 ) Each Mineral Water company of AMDK shall report itscommencement of commercial production to the Authorities

Issuing Industrial Permit or Industrial Registration Certificate.

(2 ) In case of report of commencement of commercial production issubmitted to the Director General of Agricultural and Forestry

Produce Industry, the copy thereof shall be submitted to the Head


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of Regional Office and Local Office of the Ministry of Industry

and Trade.

(3 ) In case the report of commencement of commercial production issubmitted to the Head of the Regional Office of Ministry of

Industry and Trade the copy thereof shall be submitted to the

Director General of Agricultural and Forestry Produce Industryand Head of the Local Office/Agency of the Industry and Trade.

(4 ) In case report of commencement of commercial production shallbe submi tt ed to the Head of Of fi ce of the Mini st ry of Industry and

Trade the copy thereof shall be submitted to the Director General

of Agricultural and Forestry Produce Industry and Head of the

Local Office/Agency of the Ministry of Industry and Trade.

Article 18

Each Mineral Water product shall have trademark registered

with the Ministry of Justice and obtain Domestic Product (MD) or

Imported Product Number from the Ministry of Health.

Article 19

Implementation thereof shall be free of charge.

Article 20

Further necessary provisions shall be stipulated by Director

General of Agricultural and Forestry Produce Industry.

CHAPTER X

CLOSING

Article 21

By the effectiveness hereof, all regulations relating to Mineral

Water industry provided not in contravention hereof shall remain

effective until substituted.

Article 22

This Decree shall become effective as of the date of stipulation.

Stipulated in JakartaOn May 28, 1997

MINISTER OF INDUSTRY AND TRADE

signed

T. ARIWIBOWO

Translated from Bahasa Indonesia

Jakarta, August 14, 2003


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Authorized and Sworn Translator,

AUTHORIZED TRANSLATION

APPENDIX I:

GUIDELINE OF PRODUCED PROCESS MACHINE/

EQUIPMENT OF MINERAL WATER

Principally Mineral Water (AMDK) shall be processed through 3

phases namel y: fil te ring , di sinfection, and fi ll ing. Fi ltering is meant to

remove impurity and odor contained in the water. Disinfection is

intended to remove most of microbes and kill pathogenic bacteria in

water. Filling shall constitute the last step in terms of packaging

processed water.

1. RAW MATERIALGuarantee of raw water quality shall include:

a. Organoleptic examination covering odor, taste, color, andappearance.


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b. Raw water source shall be protected against E Colicontamination.

2. MACHINE/EQUIPMENTMachines/equipment to use produce Mineral Water shall take into

account at least 2 (two) aspects:2.1. Machine equipment Material

All machines/equipment in direct contact with raw water

shall be made of food grade materials.

2.1. Type of machine/equipmentMachine/equipment to be made available production process

shall be at least:

2.2.1. Tank for raw water.2.2.2. Machines/equipment of water treatment unit shall

consist of:

a. Sand filterb. Carbon filterc. Microfilterd. Ozone generatore. Ozone mixing tank

Note:

If additional ozonization is required, ultraviolet

light with wave length of 254 mm or 2537 A

and minimum intensity of 10,000 mw second per

cm 2 can be used.

2.2.3. Bottle washer2.2.4. Filler machine2.2.5. Capping machine.

3. LABORATORY FACILITYTo test Mineral Water the Company shall have quality control

laboratory. The laboratory equipment shall be able to analyze

minimum microbiological and physico-chemical parameters

required. The equipment shall among others be:

- autoclave- oven- incubator-

pH meter- conductivimeter- turbidimeter- microbiological test equipment- glass equipment such as petridish, erlenmeyer, etc.The company may possess sophisticated equipment for physico-

chemical test such as atomic absorption spectrophotometer for

metal contaminant test. However there is none, the test can be

made at accredit ed testing laboratory.

4. PRODUCTION PROCESS


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Production process of Mineral Water (AMDK) shall be as follows:

4.1. Raw water reservoir and requirements thereof.Raw water shall be collected in a reservoir. It shall be of

food grade and free from water contaminating materials. If

source of water is far from the plant, pipeline of food grade

or tanker can be used for its transportation. The tanker shallbe of food grade and easily cleaned and di sinfected.

Note:

Tankers, hoses, and joints for raw water transportation and

unloading shall be certified food grade. The tankers have to

be cleaned, san itized and inspected, int ernally and external ly

at least quarterly.

Tankers shall to be covered with lid with packaging and seal

at manhole.

Hoses and pumps to handle raw water shall be properlycovered, safely stored and protected against any possible

contamination.

Sampling at representative quantity shall be made at each

transportation of raw water for coliform bacteria

examination and Heterotrophic Plate Count (HPC). One

sample shall be taken from each tanker in 1 (one) week.

4.2. Filtering in phases consists of:4.2.1. Filter is made of sand or other effective filter of

the same function. Sand filter is meant to filter

coarse particles. The materials are Silica particles

(SO) of at least 95%. The mesh depends on water

clarity stated in NTU.

4.2.2. Carbon filterSide function of active carbon shall be absorbing

odor, taste, color, chlor residue and organic

materials.

Active carbon can originate from coal or coconut

shell.

Absortiveness against 1 2 shall be at least 75%

(SII-0258-88).4.2.3. Micro FilterMacro filter is fine mesh filter of not more than 10

(ten) micron.

4.3. DisinfectionDisinfection it intended to kill phatogenic bacteria. Its

process occurs in ozone mixing tank and during the

existence of ozone in the package. Ozone content in the

mixing tank shall be at least 2 ppn and ozone residue a while

after filling is between 0.0 and 0.4 ppm.


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Ozone content examination is periodicall y made and

documented in the company administration. Disinfection

besides us ing ozone, can be added by any othe r effect ive

means as Ultra Violet (UV) radiation.

4.4. Container Washing4.4.1. Non disposab le Containe rGlass bottle and PC (Poly Carbonate) bottles

which can be used repeatedly shall be washed and

sanitized in bottle washer. For bottle cleaning

various food grade detergent can be used at the

temperature of 60 - 85C, while for bottle

sanitation ozone water or other disinfectant of

food grade.

4.4.2. Disposable containerDisposable container is not necessarily washed

and/or rinsed, but if so, it should be madesanitarily.

4.4.3. InspectionPre and post washing inspection shall be made

visually and meticulously for appropriateness of

bo tt le use.

4.4.4. Container LidContainer lids shall be disinfected before use.

4.5. Filing, capping and packaging

4.5.1. Filling and capping of bottle or glasses.Filling and capping of bottles and glasses shall be

made mechanically by bottle or glass capping

machines the clean and sanitized filling room. The

room temperature shall not be more than 25C.

4.5.2. PackagingMineral Water Packaging shall be: cardbox, plastic shrink

or plastic crate.

4.6. Material4.6.1. Packaging Material and requirements thereof

Mineral Water container can be made of Poly

Ethylene (PE), Poly propylene (PP), PolyEthylene Tereftalate (PET), Poly Vynil Chloride

(PVC), Poly Carbonate (PC), or glass fulfilling

SNI 12-0037-1987.

4.6.2. RequirementsNo used containers made of PE , PP , PET or PVC

shall be used. While those made of PC or glass

shall be designed in such a way that they are

washable and reusable.

4.7. Quality Control and Test.


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Quality control and test for fulfillment of SNI AMDK shall

be made by means of taking 2 (two) samples upon bottling

in which 1 (one) sample is tested on the spot and the other

on the sixth day.

Parameters to test shall be as follows:

- Water condition: odor, taste, color- PH- Turbidity- Micro be contaminant; total plate quantity bacteria in

terms of coli, C. Perfringens, Salmonella.

APPENDIX II:

GOOD MINERAL WATER PRODUCTION/PRACTICE

( AMDK)

INTRODUCTIONPrincipally each factory including Mineral Water plant shall

adopt good production practice for good production. In addition, the

factory already adopting Good Production Practice shall be ready forinspection by the competent authorities.

In order to apply good production practice and understand

anything becoming the attention of inspection, we have to first

understand matters included in good production practice of Mineral

Water in order to be prepared. Further we have to be aware of our

preparedness.

The best way is to make internal audit.


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In the interest of internal audit, it is necessary to formulate a guideline. It

constitutes explanation of Good Mineral Water Production Practice.

Part 1: PLANT CONSTRUCTION AND DESIGN ITEMS 1 14Part 2: FACILITY AND SANITARY SUPERVISION: items 15 25

Part 3: SANITARY OPERATION: items 26 35Part 4: EQUIPMENT AND PROCEDURE: items 36 40

Part 5: PROCESS AND CONTROL: items 41 57Part 6: PERSONNEL: items 58 60.

Mode of factory inspection report with columns point and deficiency is

intended to give separate judgment of each factory. Score will be give to each

item in each part. For each item already having its point, the score, the higher the

point will be, but the highest is C, meaning, very significant.

This guideline refers to Plant Inspection Handbook of IBWA and

Bottled Water Plant Inspection, NSE.

PART I

FACTORY CONSTRUCTION AND DESIGN

Item 1. EQUIPMENT AND WASTE, REFUSE, LITTER SHALL

BE PROPERLY MANAGED.

It concerns factory exterior. Negative matters such as disorderly and

unsanitary equipment storage, dusty location, piled up waste every where, etc.

Caution:

- Equipment shall be orderly and sanitarily stored.- Avoid accumulation of dust at site. Avoid piling up of scrap and

waste at inappropriate places.

- Avoid small annual nests at building exterior.- Avoid disorderly piling around the building.- Do not store scrapped, unused and unprotected equipment outside,

since they way become nests of small annuals.

Item 2. CONTROLLING DUST AT STREET, YARD AND

PARKING LOT

Inspection will pay attention to situation at factorys yard and its impact on

factory sanitary condition, especially if containers and finished products

placed outside. Dust from unasphalted parking lot shall be kept minimum.

Recommendation: If necessary, water parking lot to minimize dust.

Item 3. ADEQUATE DRAINAGE SYSTEM

Outer part of the factory must be rather sloppy to allow proper drainage

and prevent from small animal nests.


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Item 4. ADEQUATE PLACE FOR EQUIPMENT AND MATERIAL

STORAGE, UNHINDERED AND ADEQUATELY SPECIOUS

ALLEYS AND WORK PLACE.

This item merely concerns space in the factory (as opposed to item 1

outside). The entire internal area shall be accessible for inspection andsupervision of cleanliness.

There must be a space between shelves and walls, and between lowest

shelves and floor. The entire area (production, warehouse, etc.) shall be

accessible for inspection and cleaning at any time. Employees can work as usual

during inspection, without any possibility of product contamination. Goods in

contact with products shall be separated from those not. If necessary those not in

contact with products can be placed on the floor but sanitarily.

Item 5. FLOOR WALL AND CEILINGCONSTRUCTION SHALL BE

GOOD AND CLEAN.

All cases on improper construction and poor cleanliness shall be recorded

in this item. Filling room walls shall be smooth and non absorbent for easy

cleaning. Bright color material is recommended. Walls and ceiling shall be intact.

Cracks shall be immediately, patched, polished and painted to recover smooth

and flat surface. Avoid any loose pipe unsulation in filling room. Floor, walls and

ceiling shall always be clean. Cleaning shall be made routinely and on schedule.

Item 6. FIXURES, SEWER AND PIPE SHALL BE LAID IN SUCH A

WAY THAT PREVENT CONTAMINATION DUE TO

LEAKAGE AND CONDENSATION

Avoid any leakage which may result in product contamination controlled

ambient temperature can reduce condensation rate in filling room.

Item 7. FILLING IS SEPARATED FROM ANY OTHER

OPERATIONAL ACTIVITIES OR STORAGE; WALL, AND

CEILING ARE INTACT. DOORS CLOSE AUTOMATICALLY,

SIZE OF CONVEYOR HOLE SHALL NOT EXCEED BOTTLESIZE

Filling Room (RP) shall be designed only for finished product filling.

No filling or packaging of other products shall be made in Filling Room (RP).

Use of other materials not hazardous to product cleanliness, such as: laboratory

cart for testing ozone shall be allowed. Walls and ceiling shall be intact. Access

to Filling Room can be through automatically closing door, but tightly closed,

both between two door panels and door and floor. Avoid use of curtain to access

filling room since it may create positive pressure. Conveyor hole is just enough

for bottle.


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Conveyor cover shall be available to protect open bottle month before

filling and capping. Plastic curtain and strips at conveyor hole can be used

provided that:

a) Airflow in the conveyor hole is positive.b) Conveyor cover is designed in such a way that it does not create repeat

contact between curtain and sanitized bottle lip.c) Curtain is cleaned and sanitized every day.

In case of using air curtain in conveyor hole, blower shall be installed

in Filling Room in order that clean air will flow through filter unit and around

bottles. Above the point where bottle lip will pass there shall be a small piece of

stainless steel of V shape. Air curtain housing, blower or fan blades shall be dust

free. Positive pressure in Filling Room is difficult to maintain if there is an

curtain. An curtain can not be used in access to Filling Room (RP) because it

does not work as properly as automatically closing door.

Positive pressure in Filling Room means higher air pressure insidethan outside the Filling Room. Positive pressure can be detected by putting a

piece of paper at the outlet of conveyor. If it is blown outward, the pressure is

positive. Filling Room (RP) shall be properly ventilated and incoming air should

be filtered and no ventilation hole shall open outward.

Ensure that all surfaces of equipment, wall, floor, etc., in Filling

Room (RP) are cleaned and sanitized daily. Make on the said cleanliness records,

only personnel doing assignment with special suits in Filling Space area.

No glass shall be used at door and window panels since they may

draw airborne dust and dirt.

Conveyor hole is just enough for bottle to pass. When being unused or

various bottle sizes are processed in the same filling room, the hole should be

able to be closed unless there is positive pressure system working continuously.

There must be filtered and UV radiated air supply.

Door should close automatically and window must remain closed.

Ventilation may not open outward the building. Design of Filling Room (RP)

must be in such a way that all surfaces and equipment therein can be cleaned and

sanitized daily. No employee unless so authorized with appropriate clothing shall

be in the Filling Room for test or necessary works (vide item 60).

Item 8. ILLUMINATION AT WORK PLACE, HAND WASH BASIN, OR

LOCKER ROOM, TOILET AND STORAGE ROOM OF AT

LEAST 50 FOOT CANDLE

Illumination in filling area, bottle washing area and anywhere in which

there is open product and surface in contact with product shall be at least 50 foot

candle. It is intended to give enough illumination to detect any physical

contamination. Illumination in other areas such as in handwashing basin,

equipment cleansing/repair are shall be at least 50 foot candle. Avoid delivery of


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goods in contact with product, such as gallon in trailer unless there is inadequate

illumination. Employees shall have good vision to detect product contamination.

Item 9. LAMP ABOVE PROCESSING AREA, SHALL BE OF SAFE

TYPE AND PROTECTED.

Lamps all over the factory shall be shatter resistant use of shatter resistant

and/or protected lamps in filling room is compulsory avoid glass fragment from

contaminating product.

Item 10. VENTILATION SHALL BE SUFFICIENT TO MINIMIZE

ODOR, GAS OR HAZARDOUS VAPOR, AND

CONDENSATE IN PROCESSING, FILLING, BOTTLE

WASHING, AND SANITATION ROOMS AND

VENTILATION SHALL BE CLEAN.

Filling room is the most important area. It must be adequately ventilatedto minimize possibly arising condensate at/or around filling machine. Condensate

entering bottles during filling process may cause product contamination. Bottle

washing and processing and other areas in the factory shall also be sufficiently

ventilated. It is important to routinely check and replace filter when necessary

and maintain the vent dust free, in order to keep ventilation clean.

Item 11. THERE SHALL BE SCREEN OR OTHER KINDS OF

PROTECTOR AGAINST BIRD, ANIMAL, INSECTS.

Open Exterior shall be protected by screen or automatic door.

Openings outward shall be blanked to prevent insects, birds and smallanimals from entering.

Doors connecting one room to another or to receive goods shall be always

tightly closed. If open for operation it must be ensured that product and container

contamination can be avoided and small animals can not enter the factory.

Item 12. Critical

PRODUCTION PROCESS USES CLOSED PRESSURIZED

PIPELINE: FREE OF OVER LEAKAGE AND

CONTAMINATION

Raw water supply must be in closed pipeline free of large leakage and in

sanitized condition to prevent contamination harming health. Large leakage is

leakage in which water comes out; small leakage is leakage in which water drops.

They will be recorded in item 21.

Pipeline must be pressurized, while storage tank hatch shall be tightly

closed.

Item 13. BOTTLE WASHING AND SANITATION IN CLOSED SPACE

AND PLACED IN SUCH A WAY TO MINIMIZE POST

SANITATION CONTAMINATION


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Bottle washer shall be installed in closed and protected area. Bottle

washer shall not be placed in filling room. Washed bottle conveyor shall be

covered to prevent post sanitation contamination.

Item 14. PROCESSING, WASHING AND STORAGE, INDIRECTLYCONNECTED TO HOUSEKEEPING UTENSILS ROOM.

Any activities not closely related to Mineral Water facility shall not be made

within the factory. For example: hotel laundry.

PART 2

SANITARY FACILITY AND SUPERVISION

Item 15. Critical

MINERAL WATER (AMDK) ORIGINATING FROM

LICENSED SPRINGS, PROPERLY SITUATED, SECURLYOPERATED, ACCESSIBLE, SAFE, AND SANITARY:

FULFILLING THE PREVAILING LEGISLATION

REGULATION AT ANY TIME.

Inspection includes visit to raw water source. Raw water source shall be

sanitarily constructed, operated, maintained and situated as well as comply with

the prevailing legislation. They shall all be properly documented. There must be

permits from local authorities for raw water sources operation for mineral water

production, site and ownership. Permits shall be maintained. Raw water sources

shall be indicated upon inspection. If possible inspector shall inspect each source.

It documents are no longer appropriate but sanitation is, it shall be recorded in

item 57. Unsanitary operated or managed sources will be recorded in this item.

Examples: debris around and at sources.

Item 16. WATER FOR OPERATION SHALL FULFILL THE SAME

REQUIREMENTS AS THOSE IN ITEM NO. 15.

Water for factory operation shall be water for washing, toilet,

maintenance, building cleaning, etc. In case of using water from Water Supply

Company (PAM), so water bill can be documented, other wise, all documents in

item 15 shall be maintained.

Item 17. Critical

RAW WATER IS ANALYZED SEMI ANNUALLY AGAINST

CHEMICAL AND PHYSICAL PARAMETERS;

RADIOLOGICAL PARAMETER EVERY FOUR YEARS

AND COLIFORMS QUALITY WEEKLY

This item only concerns raw water, and not finished product. Coliform

test for any raw water must be made at least weekly. Raw water is also tested at

least semi annually against chemical and physical parameters. Test results are

filed in the factory.


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Radiological test shall be made at least every 4 (four) years. Requirement

of each importing country may be different. In case of any test result from the

previous 6 (six) months, no critical difference will be recorded even though test

result of six (6) current months is not yet available. But in case of the absence of

test result of current and previous year, it will be recorded as critical.

Item 18. WATER SOURCE PERMIT FROM COMPETENT

AUTHORITIES

Factory shall be equiped with permit of raw water use for mineral water

production. In case of none, there must be another document overcoming such

deficiency. The documents shall be maintained for effectiveness. Expired

documents will be recorded as deficiency in item 57.

Item 19. PRESSURIZED AIR LEADING TO MINERAL WATER

(AMDK) OR SURFACE IN CONTACT WITH PRODUCT

SHALL BE FREE FROM OIL, DUST, RUST, EXCESSIVEHUMIDITY AND SHALL NOT AFFECT

BACTERIOLOGICAL QUALITY.

All air system openings shall be dust and dirt free. No spray of

pressurized air whether or not through filter shall be made, to surface directly in

contact with Mineral Water (AMDK) product. For better information on air

quality in the main areas such as filling room, it air bacteriological quality study

shall be made. Do not direct fan to clean bottles coming out from bottle washer

because fan blades are easily dusty.

Item 20. LOCKER AND DINING ROOM ARE SEPARATED FROM

OPERATION AREA AND STORAGE ROOM: FURNISHED

WITH AUTOMATIC DOOR; CLEAN AND SANITARY;

FURNISHED WITH GARBAGE CAN, WITHOUT ANY

PACKANGING; WRAPPING AND PROCESSING

MATERIALS.

Locker and dining rooms shall be separated from operation rooms such

as filling room and storage room, by automatic door and the area shall be free

from unnecessary goods. Dining room shall have closed garbage cans.

Item 21. SEWERAGE AND PIPELINE SHALL BE PROPERLY LAID

AND MAINTAINED

Deficiency of supervision of joint and maintenance of sewerage and

pipeline shall be recorded in this item. Minor deficiency is also recorded in this

item (vide item 12). This specific deficiency includes dirty air opening, sewer and

absence of back flow in water pipeline. area in which product can be


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contaminated due to or inadequate drainage system pipeline too

complicated to evaluate, will record in a report and must consult with or

construction expert to secure system integrity.

Item 22. SUFFICIENT FLOOR OF DRAINAGE TO REMOVE FLOOR

CLEANING WATER OR WATER SPILLED ON THEFLOOR DURING OPERATION

Floor in filling room or around bottle washer shall not be inundated.

There must be adequate drain personnel to prevent it.

Item 23. ADEQUATE TOILET FACILITY, WITH WASH BASIN,

SANITARY, AUTOMATIC DOOR NOT DIRECTLY

CONNECTED TO PROCESSING ROOM; WASH BASIN.

Hand washing warning must be attached above wash basin. Toilet facility

not processing room in which product and/or surface of product but 2sets of automatic door. Ventilation only is not acceptable, facility cleanliness

maintained. There must be vestibule and also window with blind shade or

exhaust fan.

Toilet is accessible. Running water works, soap and tissue or electric hand drier

shall be clean and bright.

Item 24. ADEQUATE AND ACCESSILE HAND WASHING FACILITY

AND ACCESSIBLE SHALL BE PROVIDED AT EACH

LOCATION EMPLOYEES HAVE TO WASH HANDS

SANITATION AND THEIR HANDS; WARM AND HOT

WATER CLEAN AND DRIER SHALL BE MADE

AVAILABLE

Wash basin in the room can be replaced by well maintained dip basin.

However, good and accessible wash basins mall production rooms are

recommended.

There shall be wash basin, soap and towel close to the filling room. If

necessary can be fitted besides wash basin.

Item 25. CLOSED GARBAGE CAN IS PROVIDED

Garbage cans in the locker and dining rooms shall be furnished with

lids. In room where product residue is placed no lid is required. All garbage

cans shall be in closed condition.

DIVISION 3

SANITARY OPERATING

Item 26. Critical


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ANY SURFACE IN CONTACT WITH MINERAL WATER

EQUIPMENT, PIPE, FIXTURES SHALL CLEANSED AND

SANITIZED DAILY.

Maintain complete and up to date records of cleansing and sanitation

procedures implemented throughout the plant as well as types of cleanser andsanitiser and producers thereof. They records shall be filed in MSDS (Material

Safety Data Sheet). All procedures shall apply and be implemented to any

surface in contact with products such as bars, fillers, lids and tank interior.

Item 27. SURFACE IN CONTACT MINERAL WATER SHALL BE

FREE FROM SCALE, OXIDATION AND OTHER RESIDUE.

ANY UNSANITARY CONDITION SHALL BE

IMMEDIATELY FIXED.

Any surface in contact with Mineral water shall not indicate any rust, oil,

dust, etc. and shall be maintained properly to minimize oxidation and scaling.Records on cleansing procedure shall be maintained.

Item 28. NON-DISPOSABLE CONTAINER, TOOLS, DISMANTLED

PIPE AND CLEANSED EQUIPMENT SHALL BE

TRANSPORTED AND STORED SANITARILY.

There shall be no item in contact with Mineral water stored on the floor or

ground inside or outside plant. It also applies to tankers hose (capped when not

in use) and transfer pipe, spare gasket, etc. Caution shall be made in their

transportation so as to secure their sanitation.

Item 29. BOTTLES, CAPS OR SEALS SHALL BE PURCHASED AND

KEPT IN THEIR SANITARY DEDICATED CONTAINERS,

IN CLEAN AND DRY PLACE, CHECKED BEFORE USE,

DISTRIBUTED AND USED SANITARILY, WASHED;

RINSED AND SANITIZED IF NECESSARY.

Inadequate handling and storage of disposable bottles shall be recorded in this

item. It usually occurs to bottles directly put on the floor (by floor we mean any

surface on which people can walk on), bottles put on the floor before

dismantling, improperly packed containers, disposable bottles put unsanitarily on

semi-trailer bed, etc. They shall be washed, rinsed and sanitized using mineralwater. No lid shall be left at hopper during down-time, but it protected against

contamination. Upon cleansing filling room and equipment, including hopper,

caps shall be kept away from hopper.

Item 30. SANITIZED OPEN BOTTLES SHALL BE PROTECTED AS

OF LEAVING WASHING PLANT THROUGH FILLING

PLANT.

Handling of non-disposable bottles is included in this item. Common error in

this case is absence of conveyor cover or inappropriate conveyor cover design


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thereby giving not enough protection. Conveyor cover shall be put in place from

washing through filling. This requirements shall also apply to manual operation.

Item 31. FILLING, LIDDING, CLOSING, SEALING AND PACKING

SHALL BE MADE SANITARILY.

The entire system should always be able to maintain product intactness.

Inspector shall monitor workers habit during filling process, closing and sealing.

If necessary, lidding can be made on conveyor between filling and closing to

avoid contramination. The inspector shall also monitor procedure for manual

closing whether or not it is made sanitarily.

Note:

- Product storage outside production room shall not constitute any violation ifmade sanitarily.

- Separate filling unit from other units is acceptable. However, its placementmay serve as a potential weakness. The inspector can not request for any

separate room for these units.- In case of single operator unit properly placed but without equal protection in

filling, closing and sealing units record will be made in this item.

If the design is satisfactory but not its placement, this inadequacy will be

recorded in item 7. If both placement design are inappropriate, record will be

made in items 7 and 31.

Item 32. CLEANSING OPERATION SHALL BE MADE IN SUCH A

AWAY THAT PREVENTS CONTAMINATION OF

SURFACE IN DIRECT CONTACT WITH PRODUCT.

All cleansing operations shall be made according to Good Manufacturing

Practice (GMP). Sanitizing agent concentration shall be as recommended. Record

on cleanser and its application shall be maintained.

Item 33. IT IS ONLY TOXIC MATERIALS WHICH ARE HIGHLY

NEEDED TO MAINTAIN EQUIPMENT OR TO USE INLABORATORIUM AND PROCESSING, THAT CAN BE

USED AND STORED AT THE FACTORY. THEY SHALL BE

CLEARLY LABELLED AND USED PROPERLY.

This item deals with toxic materials in the factory, not in the yard. If any, they

must be labelled and stored separately in designated area. Containers for toxic

materials shall be conspicuous and clear permanent labels. There shall be toxic

material use schedule.

Item 34. PESTICIDE USED ACCORDING TO INSTRUCTION AND

RESTRICTION STATED IN THE LABEL.


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Pesticide to use shall be that for food factory and its use shall be according to

instruction of producer. In case of using licensed pest control device, the

inspector shall discuss it with the management. Planning of pesticide use shall be

furnished with data on licensed officer target area, target species and

concentration of application. This information shall be filed in the factory.

Item 35. SURFACE OF EQUIPMENT NOT IN DIRECT CONTACT

WITH PRODUCT SHALL BE DUST AND DIRT FREE.

Any deficiency relating to cleanliness of surface not in contact with product

shall be recorded in this item. In case of a little accumulation of dust, nothing is

considered deficiency.

PART 4

EQUIPMENT AND PROCEDURE

Item 36. EQUIPMENT SHALL BE ADJUSTED TO USE, DESIGNED

AND MADE OF MATERIALS WHICH CAN BE CLEANED

AND MAINTAINED. DESIGN IS ADJUSTED TO PRODUCT

CONTAMINATION BY LUBRICANT AND METAL PIECES,

CONTAMINATED WATER. EQUIPMENT INCLUDING

RECERVOIR AND STORAGE TANKS, PIPES, JOINTS,

BOTTLE WASHER; FILLER, LOCKER, TANKERS, ETC.

- Specific deficiency relating to equipment under this item, Example:- Absence of hopper cover- Lubricant dripping from valve- Wood in filling room- Rust, debris, heavily damaged equiment- Pressure loss at copper pipe

Item 37. Critical

SURFACE IN DIRECT CONTACT WITH PRODUCT WATERSHALL BE OF FOOD GRADE, NON TOXIC AND NON

ABSORBENT; CLEANABLE, AND WELL SANITIZED.

Certification of supplier that material in direct contact with product is

non toxic and of food grade. It shall be filed for all materials such as pipe, valve,

packaging, fitting, water coller, etc. Packaging and locker are included in item

51.

If this certificates file is complete so the purpose of this requirement is

fulfilled. In complete documents must be completed. The documents must be


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renewed every two years, if not provided in each shipment. If product is

furnished with a certificate, the product fulfills requirements.

This item also pays attention to material intactness. The heavily damaged

packaging or cleaned spacers shall also be be recorded here.

Item 38. CLOSED STORAGE TANK TO AVOID OBJECT FROMOUTSIDE; AIR FILTER IS AVAILABLE AND THE FILTER

CAN BE CLEANED OR REPLACED EASILY.

Does Overflow function as ventilation? Ventilation shall have filter to

prevent insect and air borne dirt from entering empty tanks.

Item 39: Critical.

RAW WATER IS SEPARATED FROM WATER FOR

OPERATION TO PREVAIT PRODUCT CONTAMINATION;

IT CAN BE MADE BY SEPARATE PIPELINE OR

PREVENTING BACK FLOW.

If non product pipeline is not separated totally, cross connection shall be

controlled properly. Absence of control shall be recorded cross connection

control system shall be furnished with its scheme.

Item 40: RENOVATION OF SUPPLY EQUIPMENT; USE OF

APPROPRIATE COAT; WATER DISPENSING RESERVOIR

AND VALUES ARE PROPELY SANITIZED AND

PROTECTED BEFORE REUSE.

Deficiency of supply equipment is recorded to in this item. If includes, for

instance, absence of effective pest control program, absence of fumigation before

entering the cooling storage of cleaned bottle without cover, etc.

If cooler is coated, it shall use appropriate material. Renovation elsewhere is

not deficiency, except in case of indication of insect disturbance giving rise

problems to the factory.

PART 5

PROCESS AND CONTROLItem 41. Critical

WATER TREATMENT METHOD ASSISTS ATTAINING

GOAL; AVAILABILITY OF RECORDS OF TYPE AND

DATE OF TREATMENT; PHYSICAL INSPECTION OF

EQUIPMENT; NOTICED FEASIBILITY FOR USE AND

EFFECTIVENESS.


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If the highest disinfection standard is not adopted, it shall be recorded for

control. Check if there is any proper record of water treatment equipment

maintenance.

Item 42. Critical

EQUIPMENT TREATMENT. PROCESS AND USE OFMATERIAL TO PREVENT CONTAMINATION AND

PRODUCT IMPURITY.

Equipment and operation shall be designed in such a way that eliminates the

possibility of product contamination. No nominal water shall be carried, stored or

processed using non food grade equipment/means.

Item 43. WATERS SAMPLE IS TAKEN FROM PROCESSED WATER

BEFORE FILLING TO GUARANTEE UNIFORMITY AND

EFFECTIVENESS OF WATER, TREATMENT, ANALYSIS

METHOD SHALL BE FIRST APPROVED BY COMPETENTAUTHORITIES.

Test of product sample shall be made in compliance with the most recent best

method, whether sent to laboratory outhouse or inhouse. Vide IBWAs Plant

Technical Manual regarding Test Kis. All Q.C. monitoring methods shall be

accurate and reliable.

Example: ozonemeter shall be clean and its reagent is not yet expired.

Recommendation in Q.C. (Quality Control) program and IBWA:

- Ozone residue test at least three times (3x) (at the beginning and twice pershift), preferably hourly.

- Taste, pH, khlorine and conductivity frequency will be factory specific.There must be a record of effectiveness of processing, or performance and

condition of equipment. If using in-line monitor, it shall be calibrated.

Each outhouse test shall be made by accrediated laboratory. In-house

laboratory test by chemical and microbiological analysis shall be based on

Standard Method and documented.

Item 44. Critical

ALL UNSANITARY AND/OR DEFECTIVE CONTAINERS

WILL BE RECYCLED OR DISCARDED. NO NON

DISPOSABLE CONTAINERS SHALL BE CLEANSED,

SANITIZED, AND RE-EXAMINED BEFORE FILLING,

LAPPING AND SEALING.


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All non disposable bottles shall be cleansed and sanitized before filling.

In case of using non caustic cleansing agent, sanitation shall be performed. Non

disposable bottles can be cleansed by washing, rinsing, sanitizing, and rinsing by

ozonized water. The bottles shall be checked visually or electronically before

capping and filling. Unsanitary or difective bottles shall be physically declared

defective before disposal.

Absence of declaration of unusable of unsanitary or difective bottle may

result in critical record. If may lead to inadvertent filling and production of

contaminated product.

Item 45. CONTAINERS ARE RECHECKED FOR CAUSTIC RESIDUE

AND RECORDED.

Containers shall be rechecked for caustic residue or remaining non- caustic

material, depending on type of cleansing agent in use. Recording of remaining

material shall be available. (vide IBWA Plant Technical Manual).Item 46. MECHANICAL WASHER IS CHECKED AND RECORDED

FOR PHYSICAL MAINTENANCE, SUPERVISION, FOUND

CONDITION AND APPROPRIATENESS FOR USE.

This item deals with record relating to washer and its maintenance.

Matters such as glass screen cleaning, detergent and sanitation material

concentration checking, and other maintenance shall be recorded and evaluated.

Deficiency of external part of washer will be recorded in item 36.

Item 47. NON DISPOSABLE CRATE FOR TRANSPORTATION IS

MAINTAINED TO PREVAIT CONTAMINATION PRIMARY

CONTAINER OR PRODUCT.

Reusable used plastic crate shall be thoroughly cleansed before use.

Wooden crate can be used provided properly maintained and still in good

condition and no sanitation is required.

Item 48. SANITATION TREATMENT: RECORD CONCENTRATION

SANITATION MATERIAL AND LENGTH OF CONTACT

OF SANITATION MATERIAL WITH SANITIZED

SURFACE.

This item includes all records of sanitation treatment Use of check-off

system is possible if there is written Standard Operating Procedure specifying

what to do and how. Otherwise sanitation treatment shall be recorded in detail.

Item 49. EACH CONTAINER UNIT SHALL BE IDENTIFIED BY

PRODUCTION CODE, BATCH CODE, OF CONTINOUS

PRODUCTION AND PRODUCTION DAY.


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Coding can be made by giving notch on the label, by ink jet or otherwise

provided legible and in compliance with regulation and can be explained by the

company.

Item 50. THERE MUST BE RECORD OF TYPE OF PRODUCT,

VOLUME OF PRODUCT, PRODUCTION DATE, LOTCODE, AND DISTRIBUTION TO WHOLE SALERS AND

RETAIL OUTLETS.

Record of production, distribution and information of date code shall be

adequate to guarantee recall if necessary. Recall shall be planned in writing.

Name list is not adequate to be the procedure for valid recall.

Item 51. Critical

NON TOXIC CONTAINERS AND CAPS LOCKER; FOOD

GRADE STANDARD.

This item is basicly the same as item 37, but especially for containers and

caps. The file shall fulfill requirements if there is documentation available.

Item 52. FILLING, CAPPING AND SEALING WILL BE

MONITORED, FILLED CONTAINERS, ARE INSPECTED

VISUALY OR ELECTRONICALLY.

Bottling process must be monitored at any time. Limit of content shall be

checked by certain method. One of the methods is marking empty bottle sample

at the given limit then checked if the filter can fill it up to the such limit. It is

made several times during the shift, at least at each change of product or

container. It is also recommended to keep record of content limit check. If the

bottles are not capped or sealed properly, they are discarded or reprocessed.

Skilled manpower shall check the containers against foreign objects before

entering bottle washer and filling. Deficiencies relating to cleansing and

sanitation of non disposable container shall be recorded in item 44.

Item 53. Critical

COUNT TOTAL BACTERIA AND TOTAL FUNGUS BY

DIRECT INOCULATION METHOD DIRECTLY ONCONTAINER AND BOTTLE CAP BEFORE FILLING OF

EACH TYPE OF CONTAINER DAILY.

Count the total of bacteria and fungus on container and cap of each type of

container at quantity conforming to need of each plant. Coliform examination is

made quarterly and each sample shall be coliform free. There will be at least 2

samples for each type of product for Total Plate Count (TPC), Pseudomonas

Aerogenosa and fungus.

Item 54. Critical


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REPRESENTATIVE BACTERIOLOGICAL SAMPLING AT THE

BEGINNING AND END OF PRODUCTION OF EACH TYPE

OF PRODUCTS OF ONE DAY.

Each type of product shall be analyzed against Coliform each day and each

product shall be free from Colifrom. Plate Count test shall also be made daily atthe beginning and end of production of each type of product.

Note: for 5 gallons, fungus total checking is only made monthly.

Item 55. Critical

REPRESENT SAMPLES OF EACH TYPE OF PRODUCT

TAKING EVERY TWO MONTHS FOR FULL CHEMICAL

AND PHYSICAL ANALYSIS, RADIOLOGICAL

EXAMINATION ONCE IN 4 YEARS.

All analysis results shall be recorded and kept/filed.

Item 56. MAKING RECORD OF DATE OF SAMPING, TYPE OF

PRODUCT, PRODUCTION CODE, AND ANALYSIS

RESULTS FINDINGS.

All records of items 54 and 55 shall contain clear information of sampling of

each type of product, but understandable and identifiable to identity the product

itself. Production code should facilitate distribution tracing.

Item 57. RECORDS ARE KEPT FOR 2 YEARS CERTIFICATE

OR APPROVAL FROM COMPETENT AUTHORITIES

RESOURCES AND PRODUCT AND WATER SUPPLY FOR

OPERATION ARE FILED.

All records shall be kept for at least 2 years. Certificate of the factorys

products shall also be kept for 2 years. Each expired permit shall be recorded in

this item.

SECTION 6

PERSONNEL

Item 58. FACTORY AND PERSONAL SANITATION UNDER

SUPERVISION OF APPOINTED OFFICIAL.

Official appointed and responsible for factory operation or his

successor/assignee shall be available during a shift and inspection. Whether or

not he is available will be recorded upon inspection.


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Item 59. Critical

ANY PERSONNEL WHATEVER THE POSITION WHO

SUFFERS FROM COMMUNICABLE DISEASE SHALL NOT

WORK IN CASE OF ANY POSSIBILITY OF

CONTAMINATION OF PRODUCT OR COMMUNICATIONTO OTHERS.

The manager shall be responsible for prohibiting any employee who suffers

from communicable disease to enter any area possibility of product

contamination. The area includes filling room, testing and any equipment in

contact with the product. The manager shall make a wise decision on employee

suffering from bad flu; infected wound, sore (fester) etc. Hygiene program at

work place will very help making employees aware of hygienic practice.

Item 60. PRODUCTION PERSONNEL IN DAILY PRACTICE:

WEARING CLEAN CLOTHES; DEMONSTRATINGHYGIENE/CLEANLINESS; WASHING HANDS PROPERLY;

NO WRIST ACCESSORIES; WEARING EFFECTIVE HAIR

NET/COVER; NOT USING TOBACCO OF ANY FORM; NOT

EATING AT WORK PLACE.

No smoking, eating or drinking shall be allowed at retricted places. Automatic

dispensing machine can be placed outside dining room, provided the food is

consumed in the dining room. Hair cover/net must be worn in the entire

processing area especially filling room. Any employee noticed not washing

his/her hands properly will be recorded this item.

Special apparel shall be worn in filling room. It will be living close to the

filling room.


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APPENDIX II.

MODEL OF FACTORY INSPECTION REPORT

Company areaCompany Brand Factory Address Company Address

Date of Inspection Total Control recorded Sanitary Condition

Company Permit No. Name of Factory

Manager

Address:

Phone :


Manager

Address:

Phone :


Manager

Address:

Phone :

Inspection result

discussed with:

Name of Inspector:

Instruction: Record deficiency. In case of any doubtfill item write TDT.

TDT = Not acceptable

C = Acceptable= Note

= Not observed

(Max TDT) (K)

Score= ----------------- x 100% - 1 NPS (Sanitary fulfillment

(Max TDT) Score)

Note :

..

Max = Total point

X = Deficency

Number Po int Deficiency Factory Cons truction and Design


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necessary

30 5 Open bottle already sanitized shall be

protected since coming ou t from washing

until filling

31 5 Filling, capping sealing and packaging

shall be sanitarily made32 5 Cleaning shall be made in such a way that

prevent s the contaminatio n to sur face in

direct contact with product

33 4 It is only toxic materials necessary to

protect the sani tary cond ition of facto ry

and equipment or for use laboratory and

processing, tha t can be used and stored in

the factory. They are labelled and used

proper ly

34 5 Pesticide shall be used as instructed

according to restriction contained in the

label

35 5 Equipment surface not in direct contact

with product shall be free from dust and

dirt accumulation

36 5 Equipment is adjusted to utilization,

designed and made from the materials

which can cleaned and maintained

properly. Design is adjus ted to occur rence

of product contamination by lubricant and

metal particles, contaminated water. Theequipment includes reservoir and storage

tanks, joint, bottle washer, filler, cap

tankers etc.

37 C Surface in direct contact with water

produc t sha ll of food grade, non-tox ic and

not absorbent, can cleaned and sanitized

proper ly

38 5 Storage tank is closed to prevent foreign

objects from outside, furnished with air

filter and the filter can be cleaned and

replaced easily39 C Raw water is separated from water for

operation to prevent contamination of

produc t, it can be made by separate

pipeline or black flow prevent ion

40 5 Renewal of supply equipment, use of

appropriate coating water dispensing

reservoir and values are sanitized and

proper ly protected be fore reuse

41 C Water treatment method helps attaining

goal, record type and date of treatment,


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inspection of equipment physicals

condition. Condition found, feasibility for

use and effectiveness found

42 C Treatment process of equipment and use of

material to prevent product contamination

and impurities43 5 Water sample after and before filling to

guarantee uniformity and effectiveness of

water treatment. Analysis method shall be

subject to approval of competent

authorities.

44 C Unsanitary and defective containers shall

be recycled or declare d un us ab le and

discarded. Non disposable containers shall

be cl eaned, sani ti zed and inspected be fore

filling, capping and sealing

45 4 Containers are reinspected for causticresidue and recorded

46 4 Mechanical washer shall be inspected and

recorded as to physical maintenance

supervision, condition found feasibility for

use

47 4 Non disposable crate for transportat ion

shall be maintained to guarantee non

contamination to primary container or

produc t

48 5 Sanitation treatment, record concentrat ionof sanitation material and length of time of

sanitation material in contact with sanitized

surface

50 4 Record of type of product, production

volume, production date lot code in use and

distribution to wholesalers and retail

outlets

51 C Containers and bottle caps are non-toxic

pursuant to food grade standard

52 4 Filling, capping and sealing shall be

monitored, filled containers are inspectedvisually or electronically

53 C Count total bacteri a and fungus by direct

inoculation at container and cap before

filling of each type of container daily

54 C Representa tive bacteriological sampling at

the beginning and end of production of

each type of product in one day

55 C Taking representa tive sample twice a

month from each type of product for full


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chemical and physical analysis.

Radiological inspection is made every four

years.

56 3 Record date of sampling, type of product,

produc tion code and analysis resul t

58 5 Overall factory and sanitation undersupervision of competent authorities

59 C Personnel suffering from communicable

diseases shall not work if giving rise to

possible con tamina tion to produc t or

disease communication to other person

60 6 Personnel in production shall wear clean

clothes, demonstrate cleanliness was hands

properly, no t us ing wr ist accessories,

wearing effective hair cover/net not using

tobacco in any form, not eating at work

pl ace

Translated from Bahasa Indonesia

Jakarta, August 14, 2003

Authorized and Sworn Translator,

Kep Menperindag 167 MPP Kep 5 1997 English Version

Documents

Transcript of Kep Menperindag 167 MPP Kep 5 1997 English Version