Bram-cor - Pharmaceutical Processing Systems

7/27/2019 Bram-cor - Pharmaceutical Processing Systems

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PREPARATION

LINES

CIP/SIP

SYSTEMS

ANCILLARY

SYSTEMS

PROCESSING

SYSTEMS



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BRAM-COR designs, manufactures and installs complete Formulaon & Prepara-

on Plants starng from specic Product and User Requirements .

Sterile preparaon or cleaning and sterilizaon of process vessels and contact

equipment are common issues in the pharmaceucal industry and therefore a

must in all our projects.

Specic manufacturing or sanizaon & sterilizaon requirements can be sased

by our processing systems. BRAM-COR soluons provide the opmum balance of

performance with cost eecve asepc processing equipment including:

- MIXING TANKS & BIOREACTORS

- CIP/SIP SYSTEMS

- ANCILLARY SYSTEMS FOR FORMULATION LINES

BRAM-COR PROCESSING

SYSTEMS

Boilers and pressure vessels in BRAM-COR water treatment and pro-

cessing systems are ASME cered (“S” and “U” stamp).



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DISS Preparation Systems 4

CIP/SIP Stations 7

ANSY Ancillary Systems

for Formulation Lines 8

TRANSFER PANELS

TRIBLENDERS

FILTRATION GROUPS

SOLUTION TRANSFER CIRCUITS

THROUGH NITROGEN OR SANITARY PUMPS

LAMINAR AIR FLOW CABINETS

FILTRATION GROUPS

DEVOTED SCADA SYSTEMS

VESSELS LOADING PLATFORMS

AUTOMATIC BALANCES



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DISS PREPARATION SYSTEMS

BRAM-COR oers a complete

range of preparaon lines

suitable for any pharmaceu-

cal formulaon including:

- BIOREACTORS (reactor

vessels, pressure vessels)

- MIXING TANKS (pressure

tanks, mobile mixing vessels)

- CUSTOMIZED FORMULATION

TANKS (for high purity water

mixing with powders)

- ATMOSPHERIC TRANSFER

TANKS

The accurate nishing and the

high quality of the materials

used in the construcon of allour equipment ensure asepc

drug manufacturing, in accor-

dance with internaonal cGMP

and pharmacopoeias.

All vessels are in AISI 316L stain-

less steel, internally mirror pol-

ished, thermally insulated and

clad in san nish stainless steel.

The design strictly follows PED

standard. ASME and PED cer-

caon is also available for Pres-

sure tanks.



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BRAM-COR formulaon tanks are sized according to any batch producon need, upon

careful calculaon of producon shis, opmizing product ows according to the spe -

cic lay-out.

Safe plaorms and staircases are provided to facilitate tha management and ispecon

issues of larger plants.

CAPACITIES RANGE

From 50 to 25,000 l

complete formulation lines



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permanent quality and quantitycontrol of critical parameters

Each tank is equipped with

a complete set of ngs

for quality and quanty

control such as:

- Temperature probes

- Sampling valve- Level control

- Outlet valve

- Safety valve

- Vent lter

- Manhole with

sight glass

- Cleaning spray balls

- Soluon intercepon

valve

- Load cells.

Temperature control of

the vessel can be per-

formed through a thermo-

stang unit. Compact pre-

wired mobile preparaon

units can be designed by

Technical Department ac-

cording to local space re-

quirements.

BRAM-COR range of

products can also been

integrated by ancillary

systems, for soluon prep-araon, and all necessary

devices to clean and steril-

ize the manufacturing line,

such as staonary or mo-

bile C.I.P. units.



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CIP/SIP STATIONS

BRAM-COR Cleaning in Place / Sterilizing in Place systems are designed to fully meet cGMPs requirements

in cleaning and sterilizing pracces commonly applied in pharmaceucal process lines. BRAM-COR C.I.P./S.I.P.

systems are supplied as xed STATIONS or as MOBILE SKIDS, with manual, semiautomac or automac cong-

uraon. C.I.P. systems can be equipped

with dierent ulies for heang:

- Electrical heater

- Heat exchanger by industrial steam

Each equipment is designed (in single

or multank conguraon) to achieve

the most eecve and easily validable

cleaning systems, starng from:

- Type and size of equipment to wash

- Required type of water and

chemical agent

- Pharmaceucal product to remove

- Cleaning nozzles type

- Washing sequence, automaon level

cleaning parameters

In CIP/SIP automac staons, CIP crical parameters,

such as:

- Contact me of soluon

- CIP supply temperature

- CIP return temperature

- Chemical conducvity (pH) for wash soluons

- Final rinse resisvity

- CIP soluon ow rate- Supply pressure

- Tanks levels

can be constantly monitored by the PLC and managed with

cost-savings criteria. CIP/SIP System SW can be customized

with dierent washing cycles.



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ANSY ANCILLARY SYSTEMS

FOR FORMULATION LINES

According to specic product requirements (viscosity, temperature, oxygen

sensivity, asepc issues etc.), BRAM-COR integrates his formulaon plants

with state-of-the-art:

TRANSFER PANELS

to transfer process uids through mulple process lines

TRIBLENDERS

for air-free homogeneous mixing of liquids and solids

SOLUTION TRANSFER CIRCUITS

through sanitary pipelines, pumps, ngs

LAMINAR FLOW CABINETS

ensuring asepc operaon in the working area

FILTRATION GROUPS

including sanitary cartridge lters in SS housings, pressure gauges,

temperature probes, steam traps and membrane valves

DEVOTED SCADA SYSTEMS

for control of automac sequences (i.e. startup, lling, mixing,

heang-cooling, transfer, etc.)

LOADING PLATFORMS

for safe and easy loading operaon

AUTOMATIC BALANCES

for dispensing rooms

transfer panels

Transfer panels allow an easy and proper connecon of all sanitary pipes between tanks and return line. This sys-

tem allows simultaneous connecons between dierent piping from mixers outlet. The system, composed by re-

movable stainless steel pipes, is designed to avoid “cross contaminaon“ in the simultaneous phases of producon

and CIP/SIP op-

eraon. Each pipe

is equipped with

inducve sensors

in order to allow

the right iden-

caon by the PLC

during the current

phases.



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triblenders

Solid-liquid mixtures for IV soluons shall be prepared through a sanitary triblender

for a proper dosage of solid intake and liquid ow. The triblender basically consists of a

casing and a centrifugal-pump impeller with sanitary design, sanitary single mechanical

seal, standard hopper of 40º and clamp connecons. The sucon side has a double-

wall tube that keeps the inlet of solids separate from that of liquids, thus avoiding the

formaon of ocks before the material enters the casing.

The uids enters the mixing chamber at a high velocity, thereby creang a vacuum onthe center of the impeller, which causes the sucon of the solids. The fall of the solids

can be regulated by means of a valve situated on the boom of the hopper. The system

is suitable for quick and homogeneous mixing of a great variety of solids without air

contact performing complete mixing with recirculaon of the material.

Materials:

- Parts in contact with the media:

AISI-316L

- Gaskets: EPDM according to FDA

- Mechanical seal (standard):

C/ St.St / EPDM

- Inside nishing: mirror polished,

Ra<0.5 μm

- Outside nishing: mirror polished

solutions transfer circuits

Each formulaon plant can be integrated with a soluon preparaon circuit, composed

of sanitary ngs and components, such as:

- Sanitary piping in AISI 316 L stainless steel,

conforming to ASTM A 27A code, Ra< 0.5 µm nishing,

Tri-clamp connecons

- Sanitary exibles in sanitary silicon,

Tri-clamp connecons

- Flow-sensors in AISI 316L , Tri-clamp In-Out connecons

- Sanitary Centrifugal Pump, Finishing:

internal - mirror polished Ra < 0,8 um

- Inverter in AISI 316 L SS- Pneumac/Manual sanitary membrane valves

- Thermostac steam trap on the pump drainage

- Security Sensors, in stainless steel IP68 protecon grade.



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scada systems

Each preparaon plant can be auto-

mated with a SCADA supervisory sys-

tem to control process sequences and

crical parameters such as:

- Recipe management

- Filling/emptying operaon

- Cooling/heang phases

- Mixing speed

- Soluon transfer

- CIP/SIP sanizaon

Soware development, based on va-

lidable plaorms, follows GAMP 5

standard, while 21 CFR part 11 elec-

tronic signature & records pracces

are applied for safety management

concerns, ensuring safe access policy,

audit trails and back-up management.

loading platforms

Formulaon plants are integrated with special heavy-duty 304 SS plaorms, designed according to

ISO safety standards, installed around the tanks to allow the operator to load the raw materials in

the tanks, easing use and inspecon issues of the plant. Suitable staircases with an-slip steps and

safe rails ensure easy reach of the loading level.



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filtration groups

Aer the preparaon line, BRAM-COR Filtraon Group lter the soluon

before the lling process. All surfaces in contact with the product are

polished to Ra ≤ 0.5 µm. Our ltraon groups are mainly composed of:

- Filter for Liquids, consisng in special 1,5 – 0.2 microns sterile

cartridges, in Sanitary AISI 316 L stainless steel housings ,

tri-clamp connecons

- Pressure Gauges- Temperature Probe on air lter

- Thermostac Steam trap on the Drainage

- Pneumac/Manual sanitary membrane valves

dispensing systems

Excipients to pharmaceucal soluons are prepared in the dispensing

room and weighted on special balances. Coding and labelling of the

batches is carried out through an operator panel. Each batch is idened

by a label, printed with the bench-printer in the dispensing room.

laminar flow hoods

BRAM-COR Laminar air ow cabinets are designed to prevent contamina-

on during dosing operaon in dispensing rooms. Air coming from the

HVAC ducts is rst ltered through pre-lters and then decontaminatedthrough HEPA lters. Exhaust air is sucked and expelled through rear

ducts, granng a correct air circulaon.

scales

Special sets of electronic plaorm balances and desk balances can be

provided to allow preparing

the proper formulaon in dis-

pensing room. Scaling systems

can be connected to a control

unit (Operator panel or SCADA)

for correct batch coding and

equipped with thermal panel

printers for batch idencaon

and labeling.



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BRAM-COR S.P.A - V. MERCALLI 12/A - 43122 PARMA - ITALY - TEL +39 0521 538711 - FAX +39 0521 538770

[email protected] - www.bram-cor.com - P.IVA 01699350342

© B R A M - C O R S P A - 0 2 2 0 1 8 D A T A M

A Y C H A N G E W I T H O U T N O T I C E

WORLDWIDE SERVICES

We are currently delivering our machines and building complete water treatment systems and preparaon lines all over

the world. Top quality GMP equipment must necessarily be integrated through a proper high level of professional services

including: Technical Documentaon, Factory Acceptance Test , Installaon, Commissioning, Site Acceptance Test & Start-

up, Training, Validaon, Afer Sales Service. Our worldwide network of skilled agents and our aliated companies ensure

assistance to our Clients in over 50 countries, from the very beginning of a pharmaceucal project throughout decades

aer start-up. Our Afer Sales Dept . grants punctual and quick deliveries of spares and ongoing technical support.

A full understanding of the drug producon process is the key con-

cept for correct design. BRAM-COR engineering focuses on uid

drugs sterile producon processes, such as parenteral soluons,

oral soluons, ophtalmic soluons. The denion, assessment and

monitoring of crical parameters directly aecng product qual-ity are the baseline for the applicaon of suitable Process Analy -

cal Technologies for in-line and at-line quality control. BRAM-COR

work breakdown structure consists in following main acvies:

- Design

- Construcon (mechanical, electro-

pneumac, SW conguraon)

- Tesng

- Documentaon

- Installaon

- Validaon

- Assistance

Every process follows rigorous cGMP-compliant Standard Opera-

ve Procedures. Specicaon, construcon and vericaon steps

within the lifecycle are carried out according to GAMP “V-model”,

considering risk assessment, architecture of system components,

funconal specicaon, sanizaon and validaon issues with spe-

cial overview to a sustainable maintenance of the system.

BRAM-COR KEY DESIGN CONCEPTS

Bram-cor - Pharmaceutical Processing Systems

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