STERI-PEROX 3% &...

STERI-PEROX® 3% & 6% Hydrogen Peroxide and Water for Injection Solution

Sterile Pharmaceutical Cleanroom Formula

STERI-PEROX® Technical Data File of 17

Veltek Associates, Inc. 15 Lee Boulevard, Malvern, PA 19355-1234 T: 610-644-8335 F: 610-644-8336 www.sterile.com

Rev: 07Feb2017

Product Description Veltek Associates, Inc. manufactures two hydrogen peroxide solutions, STERI-PEROX® 3% and 6% that are processed to comply with the standards required by the pharmaceutical, biotechnology, health care, and medical device industries. STERI-PEROX is recommended for use in cleanroom cleaning rotations that demand the use of a sterile hydrogen peroxide solution adequate for maintaining a clean and critical environment. As an effective one-step, ready-to-use, oxidizing cleaner, STERI-PEROX, penetrates to the surface and is tough on a variety of soils. STERI-PEROX reduces exposure concerns for VOC’s in cleanroom operations, leaves a low remaining residue, and is designed for most washable, non-porous, hard, inanimate environmental surfaces.

STERI-PEROX is Hydrogen Peroxide formulated to 3% or 6% concentrations using Water for Injection. STERI-PEROX is manufactured via aseptic fill at 0.2 microns into gamma irradiated sterile components in ISO 5 (Grade A/B, Former Class 100). Each lot of STERI-PEROX is sterility tested according to current USP Compendium, is completely traceable, and has been completely validated for sterility and shelf life. STERI-PEROX is delivered each time with lot specific Certificate of Analysis and Certificate of Sterility.

STERI-PEROX 3% and 6% concentrations are available sterile and non-sterile in a 16 oz trigger spray, 32 oz trigger spray, 1 gallon, or a 200L drum sized containers. Each sterile container is individually double bagged and packaged in two liner bags using the ABCD Cleanroom Introduction System®.

Use Limitations: STERI-PEROX is not for medical use, not for human or animal contact, and not for diagnostic or therapeutic use.

Quality and Manufacturing • Formulated with USP Water for Injection • Filled in an ISO 5 (Grade A/B, Former Class 100) • Filtered at 0.2 microns • Raw components are air washed with 0.2 micron filtered air • Aseptically filled into sterile components via gamma irradiation • Lot Sterility tested according to current USP compendium • Completely traceable from start to finish • Completely validated for sterility and shelf life

STERI-PEROX– Hydrogen Peroxide Solution and Water for Injection

Certificate of Analysis Specifications Assay 3%: 2.5%-3.5%

Assay 6%: 6.0%-6.9%

Acidity: <2.5 mL

Barium: No turbidity

Heavy Metals (as Pb): <5 ppm

Nonvolatile Residue: <30 mg

Perservative: <50 mg

Expiration Period: 2 Years



Rev: 07Feb2017

STERI-PEROX 3% & 6% 16 oz Trigger Spray

Features and Benefits • Each sterile container is double bagged packaged • Quadruple bagged in the ABCD Cleanroom Introduction System® • Individually labeled with lot number and expiration • Delivered with lot specific Certificate of Analysis and Certificate of Sterility • Specifically formulated as a sterile cleanroom pharmaceutical formula • Compatible with most surfaces • Available in two ready-to-use solutions: 3% and 6% concentrations • Available in multiple container sizes either sterile or non-sterile • Comes in a convenient 16 oz trigger spray that has the option of spray or stream • 16 oz and 32 oz containers comes with sterile spray attachment • Low remaining residue • Available in a saturated wipe: see STERI-PEROX® Wipe Uses

STERI-PEROX® solution is used for the cleaning of glass, plexiglass, walls, ceilings, floors, stainless steel, manufacturing equipment, packaging equipment, filling equipment, and most environmental, hard, non-porous surfaces that require the use of sterile hydrogen peroxide solutions in cleaning rotation cycles. STERI-PEROX helps to maintain a critical environment. It is compatible with many types of glove materials.



Rev: 07Feb2017

SPER-01-6% SPER-02-3% SPER-16Z-6%

ABCD Cleanroom Introduction System® The ABCD Cleanroom Introduction System is a packaging system that allows operators/users to take the package through each level of classified areas by simply removing one bag at a time. Each bag acts as barrier protecting the finished product from becoming a carrier of viable and non-viable contamination. This prevents the need to decontaminate each outer bag prior to entering a cleaner area. In this packaging system, sterilized groups of containers are contained in two outer bags and after each are removed individual containers are each additionally contained in two easy tear bags.

Ordering Information STERI-PEROX – Hydrogen Peroxide Solution 3% & 6% Part Number Description Qty/cs.

SPER-01-3% STERI-PEROX® 3%, 1 Gallon Solution, Non-Sterile 4

SPER-02-3% STERI-PEROX 3%, 1 Gallon Solution, Sterile 4

SPER-16Z-3% STERI-PEROX 3%, 16 oz, Unattached Trigger, Sterile 12


SPER-10-200L-3% STERI-PEROX 3%, 200L Drum, Sterile 1

SPER-01-6% STERI-PEROX 6%, 1 Gallon, Non-Sterile 4

SPER-02-6% STERI-PEROX 6%, 1 Gallon, Sterile 4


SPER-10-200L-6% STERI-PEROX 6%, 200L Drum, Sterile 1



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VAI Product Label Colors



Rev: 07Feb2017

STERI-PEROX 3% and 6% Family of Products

PRODUCT LABELING STERI-PEROX® 3% & 6%

Hydrogen Peroxide and Water for Injection

(Any specific product label is available upon request.)



Rev: 07Feb2017

STERI-PEROX® 3% and 6% Case Label

Sterile Pharmaceutical Cleanroom Formula

For Industrial Use Only

Hydrogen Peroxide at 3.00% Vol/Vol. in USP Water for Injection

Hydrogen Peroxide at 6.00% Vol/Vol. in USP Water for Injection

KEEP OUT OF THE REACH OF CHILDREN

WARNING Ingredients 3%: Hydrogen Peroxide .............................................. 3.0% USP Water for Injection ....................................... 97.0% Total .................................................................... 100.0% SDS#: SPER-98-01-3 • Rev 18Apr16 Case Label#: SPER-3%-00 Ingredients 6%: Hydrogen Peroxide .............................................. 6.0% USP Water for Injection ....................................... 94.0% Total .................................................................... 100.0% SDS#: SPER-98-01-6 • Rev 18Apr16 Case Label#: SPER-6%-00



Rev: 07Feb2017

For Spill/Exposure Emergency Response Service from the USA and Canada: CARECHEM 24 866-928-0789 Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234 USA Tel: 001-610-644-8335 Fax: 001-610-644-8336 www.sterile.com Warning HAZARD STATEMENTS: Causes serious eye irritation. PRECAUTIONARY STATEMENTS: Wash thoroughly after handling. Wear eye protection/ face protection.

See Safety Data Sheet and/or leaflet for additional product information.

USE: Use at full strength. For Spill/Exposure Response Service from Europe in English, French, and Spanish (and 23 European Languages) call +44 1235 239 670. For Arabic call +44 1235 239 671. For Chinese call +86 10 5100 3039. Precautionary Statements Product can cause moderate to severe irritation of eyes, skin and mucous membranes. Product can cause irritation of the gastrointestinal tract and respiratory tract. Contact with eyes may cause eye damage. Contact with skin may cause stinging, pain, or irritation. Ingestion/inhalation of large amounts may be harmful. Do not get this material in contact with skin or eyes. Do not inhale vapors or mists of this product. Keep container closed. Do not reuse the empty container. First Aid Eyes: Immediately flush eyes with plenty of water for at least 15 minutes. If irritation persists, get medical attention. Skin: For skin contact flush with large amounts of water. Immediately take off all contaminated clothing. Wash contaminated clothing before reuse. If irritation persists, get medical attention. Ingestion: If the material is swallowed, get immediate medical attention or advice – Do not induce vomiting. Inhalation: If inhaled, immediately remove the affected person to fresh air. If the affected person is not breathing, have a qualified individual apply artificial respiration. Call a physician immediately. Have the product or container label with you when you call a poison control center or doctor or going for treatment. For Emergency Response call 1CARECHEM24. Storage Storage: Store away from incompatible materials. To maintain product quality, do not store in head or direct sunlight.

http://www.sterile.com/



Rev: 07Feb2017

EN TESTING RESULTS SUMMARY

STERI-PEROX is not for medical use, not for human or animal contact, and not for diagnostic or therapeutic use.

STERI-PEROX® 6%

Sporicidal Efficacy: Clarification of EN Testing Routine and Results for STERI-PEROX 6%* When reading these results, it must be understood that the product was supplied at the nominal concentration of 6% having a certified concentration of 6.6% for the active ingredient hydrogen peroxide. The testing performed included a dilution to assess the other nominal concentration in the STERI-PEROX product line – STERI-PEROX 3%. It should be noted that the expression of the test results in the report is based on the nominal concentration of the product and the certified active ingredient concentration of 6.6%. We feel it is useful to note that the actual test concentration and dilutions performed during the test, illustrate the effectiveness of the product at using either statement of its concentration expressions. The dilutions tested were full strength, 1:1 (50%:50% dilution) and 1:10. The actual certified concentration of the full strength tested was 80% of actual because the test method required addition of interfering substance and test organism suspension. Therefore, the actual certified concentrations tested were 5.3%, 3.3% and 0.6%. The corresponding nominal test concentrations are equivalent to 4.8%, 2.4% and 0.5%, respectively. The full strength, and the 1:1 (50%:50%) dilutions both produced the desired >3 logs reduction of bacterial spores. Therefore, sporicidal efficacy is claimed for STERI-PEROX 6% and all dilutions of STERI-PEROX down to 2.4%. The 1:1 dilution tested is the nominal equivalent to STERI-PEROX 3% product offered by Veltek because the only difference in the formulations is the amount of water in it. The 1:10 dilution, approximately equivalent to a 0.5% - 0.6% hydrogen peroxide concentration is not considered sporicidal in 60 minutes of contact time by this method. *This document is the property of Veltek Associates, Inc. and contains confidential information. As required by law this document may be used by an authorized agent for the registration of specified products and should not be used to support the registration of any other company’s product or products.



Rev: 07Feb2017

Sporicidal Suspension Test Efficacy STERI-PEROX 6% Sporicidal suspension test. EN13704:2002 On the basis of the results obtained, in compliance with the assay validity criteria, the test item STERI-PEROX 6% causes a reduction >3Log with the test conditions of neat, i.e. 80% (maximum concentration testable because the test sample is diluted with 1 ml of interfering substance and 1 ml of microbial suspension, equivalent to 5.3% of active ingredient concentration) after 60 minutes of contact, using a 0.03% final concentration of bovine albumin, in compliance with EN 13704:2002. A series of assays were conducted on the test item STERI-PEROX 6% in order to determine its suspension sporicidal activity for the specific use of the product. A study was conducted in order to assess the suspension sporicidal efficacy of the test item, in conformity to EU regulatory requirements. The study was performed in Compliance with Good Laboratory Practice. The test Lab declares that the studies described in their report on which this summary was prepared have been conducted under their supervision and in compliance with the following standards of Good Laboratory Practice:

- OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – OECD principles of Good Laboratory Practice (as revised in 1997) – Environmental Directorate – Organisation of Economic Co-Operation and Development, Paris 1998.

- Legislative decree n.50 of March the 2nd, 2007. Enforcement of Community Directives 2004/9/CE & 2004/10/CE, concerning the inspection and verification of Good Laboratory Practice and the drawing of the legislative, regulatory and administrative dispositions relative to the application of Good Laboratory Practice rules, to the control of their application on the assays performed on the chemical substances (GU n.86 of April the 13th,2007).

- United States Food and Drug Administration, Title 21 Code of Federal Regulations Part 58, Federal Register 22 December 1978, and subsequent amendments.

- Decree of the Italian Ministry of Health October the 12th 2010, certification N. 121/2010 and Provisional Certification (October the 12th 2012) authorizing the test Lab to perform analyses in compliance with the principles of good laboratory practices.

There were no circumstances that may affect the quality or integrity of the study. No deviations occurred during the study. The sporicidal effectiveness was verified through the following tests:

- Phase 2/step 1: Sporicidal activity in suspension. Dilution – neutralization method in which spore suspension of Bacillus subtilis ATCC 6633, was exposed to the test item at the following conditions:

o Final concentrations: neat, i.e. 80% (maximum concentration testable because the test sample is diluted with 1 ml of interfering substance and 1ml of microbial suspension) – 1:1 – 1:10 equivalent to 5% - 3% - 0.6% of product concentration.

o Contact time: 60 – 120 minutes o Temperature: 20 1°C o Interfering substance: a bovine albumin solution with 0.03% final concentration

(simulating clean conditions)



Rev: 07Feb2017

STERI-PEROX 6%

Test Organisms Contact Times and Concentrations Tested

80% (neat/5%) 1:1 (3%) 1:10 (0.6%) 60 minutes

B. subtilis (spores) ATCC 6633 >2.0x103 3.9x102 <1.0x102


80% (neat/5%) 1:1 (3%) 1:10 (0.6%) 120 minutes

B. subtilis (spores) ATCC 6633 >2.0x103 >2.0x103 <1.0x102

Bactericidal Efficacy Surface Bactericidal Effectiveness Test Efficacy of STERI-PEROX 6% in the Surface Bactericidal Effectiveness Test – EVALUATION OF BACTERICIDAL ACTIVITY: CARRIER TEST (EN 13697:2001) On the basis of the results obtained, in compliance with the assay validity criteria, the test item STERI-PEROX 6% results BACTERICIDAL at the concentration of 100% after 5 minutes of contact, using a 0.03% final concentration of bovine albumin, in compliance with EN 13697-2001. The study was conducted in order to assess the efficacy of the test item, in conformity to EU regulatory requirements. The study was performed in Compliance with Good Laboratory Practice. The test Lab declares that the studies described in their report on which this summary was prepared have been conducted under their supervision and in compliance with the following standards of Good Laboratory Practice:


- Legislative decree n.50 of March the 2nd, 2007. Enforcement of Community Directives 2004/9/CE & 2004/10/CE, concerning the inspection and verification of Good Laboratory Practice and the drawing of the legislative, regulatory and administrative dispositions relative to the application of Good Laboratory Practice rules, to the control of their application on the assays performed on the chemical substances (GU n.86 of April the 13th, 2007).


- Certification N. 038/2013 released by the Italian Ministry of Health on November 19th 2013) authorizing Eurofins Biolab S.r.l. to perform analyses in compliance with the principles of good laboratory practices. (http://www.eurofins.it).

The bactericidal effectiveness was verified through the following test:

http://www.eurofins.it/



Rev: 07Feb2017

- Phase 2/step 2 bactericidal activity. Carrier test in which four bacterial strains, Staphylococcus aureus ATCC 6538, Enterococcus hirae ATCC 10541, Escherichia coli ATCC 10536 and Pseudomonas aeruginosa ATCC15442, were exposed to the test item in the following conditions:

o Final concentrations: 100% - 1:1 – 1:2 (equivalent to respectively 6.2% - 3.1% - 2.1% of active ingredient concentration, hydrogen peroxide as per Certificate of Analysis of the analyzed batch).

o Contact times: 5 – 10 minutes o Temperature test: 20°C±1°C o Interfering substance: bovine albumin solution with a 0.03% final concentration

(simulating clean conditions). The test was performed on steel carriers.

STERI-PEROX 6%

Microorganism Test Contact Times and Concentrations Tested

100% 1:1 1:2 5 minutes

Staphylococcus aureus ATCC 6538 4.02 2.53 2.28

Pseudomonas aeruginosa ATCC 15442 >6.00 3.41 2.83 Escherichia coli ATCC 10536 >5.93 3.43 2.92

Enterococcus hirae ATCC 10541 4.07 v1.81 1.46


100% 1:1 1:2 10 minutes

Staphylococcus aureus ATCC 6538 >6.49 3.71 2.44

Pseudomonas aeruginosa ATCC 15442 >6.00 >6.00 3.51

Escherichia coli ATCC 10536 >5.93 >5.93 3.62

Enterococcus hirae ATCC 10541 >6.65 3.19 2.08 *The test item is considered bactericidal when ME≥4 Log at least following 5 minutes of contact. Bactericidal Suspension Test Efficacy STERI-PEROX 6% bactericidal suspension test. EN1276:2009 On the basis of the results obtained, in compliance with the assay validity criteria, the test item STERI-PEROX 6% causes a reduction >5Log with the test conditions of neat, i.e. 80% (maximum concentration testable because the test sample is diluted with 1 ml of interfering substance and 1 ml of microbial suspension, equivalent to 5.3% of active ingredient concentration) after 10 minutes of contact, using a 0.03% final concentration of bovine albumin, in compliance with EN 1276:2009.



Rev: 07Feb2017

A series of assays were conducted on the test item STERI-PEROX 6% in order to determine its suspension bactericidal activity for the specific use of the product. A study was conducted in order to assess the suspension bactericidal efficacy of the test item, in conformity to EU regulatory requirements. The study was performed in Compliance with Good Laboratory Practice. The test Lab declares that the studies described in their report on which this summary was prepared have been conducted under their supervision and in compliance with the following standards of Good Laboratory Practice:





There were no circumstances that may affect the quality or integrity of the study. No deviations occurred during the study. The bactericidal effectiveness was verified through the following tests:

- Phase 2/step 1: bactericidal activity in suspension. Dilution – neutralization method in which 4 different bacterial strains, Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC 15442, Escherichia coli ATCC 10536, Enterococcus hirae ATCC 10541, were exposed to the test item at the following conditions:

o final concentrations: neat, i.e. 80% (maximum concentration testable because the test sample is diluted with 1 ml of interfering substance and 1 ml of microbial suspension) – 1:1 – 1:2 equivalent to 5.3% - 3% - 2% of product concentration.

o contact time: 10 minutes o temperature: 20 1°C o interfering substance: a bovine albumin solution with 0.03% final concentration


STERI-PEROX 6%


80% (neat/5%) 1:1 (3%) 1:2 (2%) 10 minutes

Staphylococcus aureus ATCC 6538 >5.33 >4.26 <4.26



Rev: 07Feb2017

Pseudomonas aeruginosa ATCC 15442 >5.38 4.85 <4.31 Escherichia coli ATCC 10536 >5.42 5.04 <4.35

Enterococcus hirae ATCC 10541 >5.52 <4.45 <4.45

Fungicidal Efficacy Surface Fungicidal Effectiveness Test Efficacy of STERI-PEROX 6% in the Surface Fungicidal Effectiveness Test EVALUATION OF FUNGICIDAL ACTIVITY: CARRIER TEST (EN 13697:2001) On the basis of the results obtained, in compliance with the assay validity criteria, the test item STERI-PEROX 6% results FUNGICIDAL at the concentration of 100% after 10 minutes of contact, using a 0.03% final concentration of bovine albumin, in compliance with EN 13697:2001. The study was conducted in order to assess the efficacy of the test item, in conformity to EU regulatory requirements. The study was performed in Compliance with Good Laboratory Practice. The test Lab declares that the studies described in their report on which this summary was prepared have been conducted under their supervision and in compliance with the following standards of Good Laboratory Practice:




- Certification N. 038/2013 released by the Italian Ministry of Health on November 19th 2013) authorizing Eurofins Biolab S.r.l. to perform analyses in compliance with the principles of good laboratory practices. (http://www.eurofins.it).

There were no circumstances that may affect the quality or integrity of the study. No deviations occurred during the study. The fungicidal effectiveness was verified by performing the following test:

- Phase 2/step 2 fungicidal activity. Carrier test in which two fungi strains, Candida albicans ATCC 10231 and Aspergillus niger ATCC 16404 were exposed to the test item in the following conditions:

o Final concentrations: 100% - 1:2 – 1:3 (equivalent to respectively 6.2% - 2.1% - 1.6% of active ingredient concentration, hydrogen peroxide, as per Certificate of Analysis of the analyzed batch)

o Contact time: 10 - 15 minutes

http://www.eurofins.it/



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o Temperature test: 20°C±1°C o Interfering substance: bovine albumin solution with a 0.03% final concentration

(simulating clean conditions) The test was performed on stainless steel carriers.

STERI-PEROX 6%


100% 1:2 1:3 10 minutes

Candida albicans ATCC 10231 >5.97 2.42 2.13

Aspergillus niger ATCC 16404 >5.83 2.27 1.33


100% 1:2 1:3 15 minutes

Candida albicans ATCC 10231 >5.97 2.97 2.71

Aspergillus niger ATCC 16404 >5.83 2.65 1.62 *The test item is considered fungicidal when ME≥3 Log at least following 15 minutes of contact Fungicidal Suspension Test Efficacy STERI-PEROX 6% fungicidal suspension test. EN1650:2008 On the basis of the results obtained, in compliance with the assay validity criteria, the test item STERI-PEROX 6% causes a reduction >4Log with the test conditions of neat, i.e. 80% (maximum concentration testable because the test sample is diluted with 1 ml of interfering substance and 1 ml of microbial suspension, equivalent to 5.3% of active ingredient concentration) after 10 minutes of contact, using a 0.03% final concentration of bovine albumin, in compliance with EN 1650:2008. A series of assays were conducted on the test item STERI-PEROX 6% in order to determine its suspension fungicidal activity for the specific use of the product. A study was conducted in order to assess the suspension fungicidal efficacy of the test item, in conformity to EU regulatory requirements. The study was performed in Compliance with Good Laboratory Practice. The test Lab declares that the studies described in their report on which this summary was prepared have been conducted under their supervision and in compliance with the following standards of Good Laboratory Practice:




Rev: 07Feb2017




There were no circumstances that may affect the quality or integrity of the study. No deviations occurred during the study. The fungicidal effectiveness was verified through the following tests:

- Phase 2/step 1: fungicidal activity in suspension. Dilution – neutralization method in which 2different mycetes, Candida albicans ATCC 10231 and Aspergillus niger ATCC 16404, were exposed to the test item at the following conditions:

o Final concentrations: neat, i.e. 80% (maximum concentration testable because the test sample is diluted with 1 ml of interfering substance and 1 ml of microbial suspension) – 1:1 – 1:2 equivalent to 5% - 3% - 2% of product concentration.

o Contact time: 10 minutes o Temperature: 20 1°C o Interfering substance: a bovine albumin solution with 0.03% final concentration


STERI-PEROX 6%


80% (neat/5%) 1:1 (3%) 1:2 (2%) 10 minutes

Candida albicans ATCC 10231 >4.41 <3.04 <3.04

Aspergillus niger ATCC 16404 >4.13 <3.06 <3.06



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Additional Documentation Upon request, the following additional documentation is available:

• Specific Product Testing Reports • Safety Data Sheet

o STERI-PEROX 3% SDS# SP-98-01-3 o STERI-PEROX 6% SDS# SP-98-01-6

• Product Validation • In-Use Validation • Sample lot specific documentation packages including Certificates of Sterility and Certificates of

Analysis

VAI’s Sterile Chemical Manufacturing Division - SCMD manufactures a complete range of

cleaning agents and disinfectants that are used daily in cleanroom operations. Overall, VAI’s capabilities for manufacturing products include the ability to fill aerosol, bulk, and unitdose packages in ISO 5 (Grade A/B). Our aseptic filling operations are coupled with the validated and proven ability to irradiate a final

product. Assurances are taken in every aspect of SCMD concerning sterility and particulate removal. VAI’s operations mirror current GMP’s and enforces the adherence to USP specifications. VAI is an

EPA and FDA registered facility. To learn more about our division capabilities please visit www.sterile.com.

Patents: www.sterile.com/patents

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