vuelife® and kryosure® fep bags

(Manual 003, Rev C) of 39

Cell Therapy Technical Dossier

Technical Dossier

VueLife® and KryoSure® FEP Bags

Manual 003, Revision: C Effective: August 3, 2020



VueLife® and KryoSure® Bags

Table of Contents

1 Manufacturing Site ........................................................................................................................................................ 3

2 Product Description ..................................................................................................................................................... 9

3 Sterility Assurance ..................................................................................................................................................... 18

4 Shelf Life and Storage Requirements .................................................................................................................. 21

5 Biocompatibility.......................................................................................................................................................... 23

6 Cleanliness .................................................................................................................................................................... 26

7 Extractables .................................................................................................................................................................. 29

8 Product Stewardship................................................................................................................................................. 33

9 General Information .................................................................................................................................................. 35

10 Disclaimers ................................................................................................................................................................... 37



1 Manufacturing Site



VueLife® and KryoSure® FEP bags are manufactured in an ISO 7 certified cleanroom manufacturing space located at 50 W. Watkins Mill Road, Gaithersburg MD 20878. The table below is an overview of the manufacturing space and core capabilities:

Table 1 – Manufacturing Site Overview and Core Capabilities

The manufacturing spaces are classified as ISO 7 and the airlocks are classified as ISO 8 in accordance with ISO 14644-1:2015. These spaces are re-certified annually which include the following:

HEPA Filter Integrity

Room Pressurization Testing

Airflow Volume

Total Nonviable Airborne

Particulate Counts

Smoke Studies

Following completion of construction activities in 2016, EMPQs were performed to identify the baseline prior to cleaning as well as the static and dynamic environment post-cleaning. Sample locations were identified using an Environmental Monitoring Risk Evaluation Method (EM-REM) to select risk based EM sample locations based on people, activity and contamination sources present in support of the temporary sampling plan. In 2019, the static and dynamic EMPQs were re-executed to verify on-going suitability of the EM and cleaning programs. Routine EM activities are as follows:

Non-viable Particulate Count: Weekly

Viable Air and Surface: Monthly TSA and Quarterly SDA

Temperature: Continuous Monitoring

PROPERTY: ~35,000 sq ft Facility, ~15,000 sq ft Cleanroom Space

SITE DETAILS: ~50 Employees, 1 Manufacturing Shift, ISO 7 / 8 Cleanroom Manufacturing

MAIN CAPABILITIES: Laser Welding, Thermal Welding, Collar Sealing, Assembly, Injection Molding, Filtration Technologies Distribution, Moist Heat Steam Sterilization

CAPACITY: 3 Laser Welders, 1 Thermal Welder 4 Molding Machines, 8 Collar Sealers, 1 CMM, 1 O-Inspect

REGISTRATIONS/CERTIFICATIONS: ISO 13485:2016



Humidity: Continuous Monitoring

Pressure Differential: Continuous Monitoring

Regular cleaning is being performed to ensure the status of the environment is being maintained and to reduce the level of bioburden such that an SAL 10-6 can be obtained for all sterile product. Details are as follows:

Daily: Critical contact surfaces Decon- Spore (disinfectant) and 70% IPA wipe or distilled water.

Weekly: Decon-Clean and 70% IPA wipe or distilled water rinse of walls and floors. Followed by

Decon-Spore (disinfectant) and 70% IPA wipe or distilled water rinse for critical product contact

surfaces.

Monthly: Cycle in Hypo-Chlor for Decon-Spore.

Semi-Annual: Decon-Clean and 70% IPA wipe or distilled water rinse of airlock ceilings. Followed

by Hypo-Chlor Neutral (disinfectant) and 70% IPA wipe or distilled water rinse for critical product

contact surfaces.

Annual: Decon-Clean and 70% IPA wipe or distilled water rinse of manufacturing space ceilings.

Followed by Hypo-Chlor Neutral (disinfectant) and 70% IPA wipe or distilled water rinse for

critical product contact surfaces.



Image 1 – Manufacturing Layout

All employees and visitors are required to gown in accordance with site gowning procedures. The gowning program has been designed to ensure minimal risk of product contamination. All gowning materials are single use washable materials which are changed daily. All gloves and bouffant are discarded after each use. The image below is an example of a fully gowned employee:



Image 2 – Fully Gowned Individual

Note: Manufacturing Staff have dedicated shoes for the cleanroom and are not required to wear shoe covers.



Attachment 1 – ISO 13485:2016 Certification



2 Product Description



Intended Use Saint-Gobain VueLife® FEP bags are intended to be used for the processing of cells (e.g. sorting, transfer, culture, expansion, modification) stemming from tissues, blood, blood components and cord blood, as part of cell therapy products development and manufacturing stages. Saint-Gobain KryoSure® FEP Bags are intended to be used for the storage, preservation (including cryopreservation) and transportation of cell therapy medicinal products. VueLife® and KryoSure® FEP bags are made using USP Class VI fluorinated ethylene propylene (FEP) film. With high oxygen permeability and low water vapor permeability coupled with a broad continuous service temperature range, FEP is an ideal material choice for a wide array of applications in cell culture and cryopreservation. The FEP film and ports used in the bags are certified to be free of animal-derived components. Table 2: FEP Film Permeability Properties

Property

ASTM Standard

Typical Value

O2 Transmission Rate @ 25°C

D3985

~2300 cc/m2-day

CO2 transmission Rate @ 25°C

F2476

~4000 cc/m2-day

Water Vapor Transmission Rate @ 37.8°C

F1249

~0.7 g/m2-day

Chemical Compatibility Saint-Gobain has performed targeted chemical testing with common end use chemicals and the FEP resin used in the manufacturing of the film. The method employed was a soak test over 72 hours at room temperature to determine weight change. The following chemicals were used:

100% DMSO

10% DMSO

70% IPA

35% H2O2

The results indicated that there was no change in weight over time and FEP is compatible with the above chemicals. In addition, it commonly understood that FEP is resistant to all common solvents and chemicals excluding molten alkali metals, gaseous fluorine and halogenated compounds. Saint-Gobain recommends that the end user perform feasibility and compatibility assessments on the interaction of their processing chemicals with VueLife® and KryoSure® Bags.



Precautions

VueLife® Culture Bags are provided sterile. Provided that the integrity of the package is not compromised

in any way for sterile VueLife® Culture Bags, the packaging will serve as an effective sterile barrier until

the expiration date shown on the label. If the packaging is damaged or compromised, the VueLife®

Culture Bags should not be used.

VueLife® Culture Bags are designed for single use only, do not reuse the device.

VueLife® Culture Bags are equally gas permeable on top and bottom. Therefore, efforts should be made

to ensure that neither side is obstructed from gas flow.

When storing on incubator shelves, ensure there is separation between the bag and shelf to allow for

adequate permeation of gases.

Centrifugation of the bags is not recommended.

Cryopreservation can only be utilized with KryoSure® FEP bags.

Manufacturing Process VueLife® and KryoSure® FEP Bags The manufacturing process begins with a proprietary laser welding process. Prior to the film being placed on the laser welder, there is a particulate removal step on each side of the film. The laser welder brings the FEP film to its melting point which creates a bond between two layers of FEP film. From welding, the product is subjected to an initial trim of excess material and 100% visual inspection where product is accepted or rejected based on the level of particulate identified. In-process product is then transferred to laser trim and engrave were the additional excess FEP is removed and the bag is in its final form. At this step, the product is also engraved with the lot number, part number and Saint-Gobain logo (where applicable). Following laser trim and engrave, product is inspected and any FEP dust is removed from the exterior of the bag. In-process product is then transferred to collar seal and pressure test. During this operation a pre-determined size port is sealed into an opening of the of the FEP bag. Product is then 100% pressure tested at 5 psi for 60 seconds to detect leaks around welds and collar seals. Custom assemblies are attached to the bag if applicable. In-process product then moves to clean and pack where it is cleaned and placed into an autoclavable pouch. During this operation the autoclave pouch is stamped with the lot, part number, and date of expiration. Product then goes to macro inspection where an AQL sampling is performed followed by sealing of the autoclave pouches. Product is then subjected to moist heat steam sterilization (if product is sterile) followed by a 100% visual inspection to ensure product integrity has been maintained and the indicator has turned brown on the autoclave pouch. Product is then bundled and sealed in a non-sterile barrier polybag and labeled. The images below are examples of the process flow and finished product label.



Image 3 – Process Flow Diagram

Image 4 – Sterile VueLife® Product Label



Image 5 – Non-Sterile VueLife® Product Label



Image 6 – Sterile KryoSure® Product Label

Image 7 – Non-Sterile KryoSure® Product Label



Attachment 1 – Certificate of Conformance



Attachment 2 – Certificate of Analysis



Attachment 3 – Certificate of Sterilization



3 Sterility Assurance



The acceptable mode of sterilization for the FEP bags is moist-heat steam sterilization. Sterilization activities are performed on location in one of two identical autoclaves. A contract steam sterilizer is also qualified for business continuity purposes. Details below summarize the sterilization validation activities. Sterilization validation studies including cycle development were performed on the autoclaves. The methodology that was used for this validation was in accordance with ANSI/AAMI/ISO 17665-1:2006, Annex D: Conservative process definition based on inactivation of reference microorganisms (overkill method). This validation consists of both physical and microbiological qualifications. All outputs of the aforementioned protocol were successfully executed meeting all predefined criteria. Summary data of these outputs is provided in the subsequent pages of this report. The objective of the study was to provide documented evidence that the moist heat steam sterilization process met the requirements of ANSI/AAMI/ISO 17665-1:2006, Annex D as well as internal Saint-Gobain requirements. The end result was to ensure Saint-Gobain Gaithersburg’s VueLife® Cell Culture FEP Bags, KryoSure® Cryopreservation FEP Bags, and KryoVue® overwrap pouches FEP Bags and Accessories were appropriately sterilized to meet an SAL10-6 under the cycle used for this validation. The following activities were in scope of the validation:

Steam Quality Testing Bowie-Dick test pack Pre and Post Calibration of Thermocouples Loading of Bags, Thermocouples and BIs. Kaye AVS (data collection system) setup and reports Weighing of Bags Pre and Post moisture retention and material effect cycle BI processing including enumeration

Validation Results Steam quality testing was completed on each autoclave for non-condensable gases, dryness

values and super heat. A Bowie-Dick test pack and cycle was run on each autoclave. All results were passing. Moisture Retention and Material Evaluation was completed and there was no visual evidence of

moisture found and all bags weighed the same or less prior to the sterilization cycle. All product inspected met internal inspection requirements.

All pre cycle calibrations and post cycle verifications were within specification Triplicate sterilization cycles were ran using minimum and maximum loads with biological

indicators (BI) and thermocouples. Positive control BIs were submitted for testing with validation cycle BIs. Enumeration studies

were also performed for each lot of BIs to confirm it contained 1.8x10^6 cfu. All exposed BIs were negative and the positive control and enumeration studies confirmed 1.8x10^6 cfu.



Thermal mapping confirmed that sterilization exposure temperature was maintained within the allowable limits for each cycle.



4 Shelf Life and Storage Requirements



Based on information provided by our suppliers, FEP bags are not considered to be temperature sensitive or have special storage conditions. Products awaiting shipment are stored in ambient lighting, temperature and humidity conditions. Ambient storage conditions consist of a cool dry environment away from direct sunlight at 70°F ± 20°F and a relative humidity range from 10% to 70% in original unopened packaging. Given all possible variables have not been examined, it is best practice to store product in its original packaging, protected from known sources of polymer degradation such as temperature, condensing or high humidity, sunlight/fluorescent light/UV, exhaust gases, chemical environment, mechanical stress, etc. Saint-Gobain certifies that the sterile barrier of the FEP bag and the FEP bag weld are stable for 3 years from date of sterilization. FEP bags with treatment are stable for 1 year from date of manufacturing. Ongoing real time aging studies are being performed and final data will be included in this dossier upon completion of those studies.



5 Biocompatibility



USP <88> Biological Reactivity Tests, in vivo, Systemic Injection Test The USP <88> Systemic Injection Test assesses the systematic response of the sample extract solution in test animals following intravenous or intraperitoneal injection. Test: Autoclaved samples of VueLife® FEP Bags were tested by NAMSA in accordance with USP 41 NF 36, 2018, General Chapter <88>, Biological Reactivity Tests, in vivo, Systemic Injection Test. The samples were extracted in alcohol in saline, 0.9% sodium chloride (saline), polyethylene glycol and sesame oil. All caps in the packaging and the entire bag were agitated continuously at 70℃ for 24 hours at a surface area to volume ratio of 6 cm2/ml. A single dose of each extract was injected systemically into groups of five mice. Similarly, a separate group of five mice were dosed with each corresponding extraction vehicle alone (control). The animals were observed for signs of systemic toxicity immediately after injection and at 4, 24, 48 and 72 hours after injection. Body weights were recorded prior to dosing and on day 3. Results: None of the animals exhibited any signs of systemic toxicity. The VueLife® FEP Bags therefore met the requirements of the USP <88> Biological Reactivity Tests, in vivo, Systemic Injection.

USP <88> Biological Reactivity Tests, in vivo, Intracutaneous Test The USP <88> Intracutaneous Test assesses the potential of the sample extract to cause local irritation following intradermal injection in a live animal. The test animal is monitored for signs of irritation and/or toxicity. Test: Autoclaved samples of VueLife® FEP Bags were tested by NAMSA in accordance with USP 41, NF 36, 2018, General Chapter <88> Biological Reactivity Tests, in vivo, Intracutaneous Test. Samples were extracted with USP 0.9% Sodium Chloride, Sesame Oil, 1 in 20 Alcohol in Saline or Polyethylene Glycol 400 at 70℃ for 24 hours at a test article surface area to extraction vehicle volume ratio of 6 cm2/ml. The test article extracts and corresponding controls were injected intracutaneously into rabbits and the animals were observed at 24, 48 and 72 hours for signs of skin reactivity or toxicity. Results: None of the animals injected intracutaneously with test article extracts exhibited any signs of erythema, edema or clinical toxicity. The test article therefore met the requirements of USP <88> Biological Reactivity Tests, in vivo, Intracutaneous Test.

USP <88> Biological Reactivity Tests, in vivo, Implantation Test The USP <88> Implantation Test assesses the potential of the test article to cause irritation when in direct contact with living tissue. Test: Autoclaved samples of VueLife® FEP bags were tested by NAMSA in accordance with USP 41, NF36, 2018, General Chapter <88> Biological Reactivity Tests, in vivo, Implantation Test. Samples were



intramuscularly implanted and animals, monitored for 7 days then euthanized. Muscle tissues were excised and the implant sites examined macroscopically. Results: All animals appeared clinically normal throughout the study. The macroscopic reaction was classified as not significant tissue contact irritation. The implanted test article met the USP <88> Biological Reactivity, in vivo, Implantation Test requirements.

USP <88> Class VI USP Plastic Class VI is one of six designations for plastics from the General Chapter of the United States Pharmacopeia and National Formulary (USP-NF) and is a guideline for how to test and certify plastic materials. The Class levels are intended to match with the end use state of the material. Classes IV and VI are specifically for plastics that are intended to be used in an implantable application. If the plastic of interest is not intended to be used as an implantable plastic Class I through III and V are appropriate. Class VI testing includes the testing for all the other classes as well as the implantation test. For a plastic material to meet USP Class VI it is required to be tested for Systemic Injection Test (Section 4.1) using four different extractants (Sodium Chloride, Alcohol Chloride, Polyethylene Glycol and Vegetable Oil), Intracutaneous Injection test (Section 4.2) also using the same four solvents and implantation (Section 4.3). The VueLife® FEP Bag has been tested for Systemic Injection, Intracutaneous Injection, and implantation using all required extractants where specified and meets the criteria for USP <88> Class VI plastic.

ISO 10993-5 Tests for in vitro Cytotoxicity Cytotoxicity testing assesses the potential of a given material to have a toxic effect on living cells. Test: Autoclaved samples of VueLife® FEP Bags were tested by NAMSA in accordance with ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity. The test article was extracted in single strength Minimum Essential Medium (1X MEM) at 37°C for 72 hours under constant agitation at a surface area to volume ratio of 6cm2/ml. Positive and Negative controls were also extracted at 37℃ for 72 hours at a ratio of 6 and 3 cm2/ml, respectively. Triplicate monolayers of L-929 mouse fibroblast cells were dosed with each extract and incubated at 37°C in 5% CO2 for 48 hours. Cultures were monitored for lysis or toxicity and rated on a scale of 0 (No Biological Reactivity) to 4 (Severe Biological Reactivity)

Results: The test article samples and the negative controls scored a Grade 0 for Biological Reactivity after 48 hours. The positive controls scored a Grade 4 at the 48-hour mark. Samples are deemed to meet the test requirements if they exhibit a Biological Reactivity of no more than Grade 2 (Mild Reactivity). The test articles are therefore considered non-cytotoxic.



6 Cleanliness



USP <85> Bacterial Endotoxin Endotoxins are lipopolysaccharide complexes found in Gram negative bacterial cell walls. They can cause significant illness in humans. The Limulus Amebocyte Lysate (LAL) Gel Clot Test is used to detect and quantify endotoxin levels in test samples.

Test: Autoclaved samples of VueLife® FEP bags were tested by Saint-Gobain in accordance with USP 32, NF 27, 2009, General Chapter <85> Bacterial Endotoxins Test, Gel Clot Method. Three samples from three lots (9 total) were extracted at room temperature by filling the bags will endotoxin free water and agitating for 1 minute at a surface area to volume ratio of 6cm2/ml. The extract was tested using Limulus Amebocyte Lysate (LAL) Gel Clot Test to detect and semi-quantify the endotoxin levels. Positive and negative control samples were tested. Results: Neither the negative control samples nor the product test samples showed clotting of the lysate reagent in the presence of endotoxin. The VueLife® FEP Bag sample endotoxin level was determined to be < 0.03 EU/ml (< 0.005 EU/cm2). The positive product controls demonstrated clotting indicating that the product did not interfere with the test.



USP <788> Subvisible Particulates Solutions intended parenteral use must meet specified limits for Subvisible particulates. The limits are based on the dosage of the given solution and testing must be performed on the final drug product. This testing is to quantify the Subvisible particulate contribution from samples of VueLife® FEP Bags. Test: Autoclaved samples of VueLife® FEP Bags were tested by Saint-Gobain in accordance with USP 38, NF 33, 2015, General Chapter <788> Particulate Matter in Injections, Method 2 - Microscopy. Three samples from three lots (9 total) were extracted at room temperature by filling the bags with 110 mL of particulate free water and agitating for 1 minute. The extraction surface area to volume ratio was 6cm2/ml. Each extraction was tested in duplicate. Positive and negative control samples were tested. Results: The test article results are summarized in the table below. Particulate levels were corrected for background.

Table 3: VueLife® FEP Bag Particulate Results

Lot Average Particles/ml

>10 µm >25 µm

Lot A 0.92 0.27

Lot B 1.10 0.40

Lot C 0.90 0.28

Positive Controls (Average) 24 NA

USP<788> Test 2A Specification ≤ 12 ≤ 2



7 Extractables



USP <661> Physicochemical Tests for Plastics Physicochemical testing is performed to assess the suitability of the test article for use in contact with drug products for parenteral administration in humans.

Test Lab: Saint-Gobain Testing Date: June 2018 Product: VueLife® FEP Bags Lot #: 23371011 Post Treatment: Autoclave

Test: Autoclaved samples of VueLife® FEP Bags were tested by Saint-Gobain Research Shanghai in accordance with USP 41 NF 36, 2017, General Chapter <661>, Physicochemical Tests. The test article was extracted with purified water at 70°C for 24 hours at a surface area to volume ratio of 6 cm2/ml. The bag was filled with the extraction fluid and periodically agitated during the extraction cycle. The resulting extract and sample blanks were tested. Results: The test article met the criteria established per USP<661>, Physicochemical tests. The test results are summarized in the table below.

Table 4: VueLife® FEP Bags USP<661> Physicochemical Tests Results

Assay Results Limits Based on Area

Non-Volatile Residue < 1 mg ≤ 15 mg

Residue on Ignition < 1 mg* ≤ 5 mg

Heavy Metals < 1 ppm < 1 ppm

Buffering Capacity < 1 ml ≤ 10 ml

*Based on non-volatile residue results

Total Organic Compounds (TOC) TOC is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. TOC may be introduced to the water from packaging, containers or storage devices. Test: Two autoclaved samples of VueLife® FEP Bags was tested by Saint-Gobain Research Shanghai in for Total Organic Carbon. The test articles were extracted with purified water at 70°C for 24 hours at a surface area to volume ratio of 6 cm2/ml. The bags were filled with the extraction fluid and periodically agitated during the extraction cycle. A change in TOC content in the extraction solution provides more information about the total amount of organic material that migrates from the test article into the extraction. Results: The VueLife® FEP Bags’ corrected* TOC result is less than the test’s limit of detection of 0.08μg/mL.



Semi-Quantification and Identification of Extractables Test: Samples of the VueLife® C (P/N: 2PF-290) were tested by Saint-Gobain Research Shanghai (SGRS) for extractables using purified water, 70% Ethanol/ 30% Water, and dimethyl sulfoxide (DMSO) as the extraction solvents. All extractions were performed at 70°C for 24 hours at a surface area to volume ratio of 6.0. The bags were autoclaved at 121°C for 60 minutes prior to testing. Each extract was tested using the analytical methods in the table below. The purpose of this testing is to identify and quantify the extractables that may migrate from samples of VueLife® bags. The extractable testing protocol was developed using USP<661> Containers – Plastics (2008), PQRI Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products (2006) and the BPSA industry trade group recommendations for Extractables and Leachables Testing (2007).

Table 5: Summary of Semi-Quantification and Identification of Extractables Tests

Test

Description

Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP/AES)

Quantitative analysis for metal ions

Headspace Gas Chromatography/Mass Spectroscopy (HS GC/MS)

Semi-quantitative analysis for volatile organic compounds

Direct-injection Gas Chromatography / Mass Spectrometry (DI GC/MS)

Semi-quantitative analysis for semi-volatile and volatile organic compounds

Liquid Chromatography / Ultraviolet / Mass Spectrometry (LC/UV/MS)

Semi-quantitative analysis for non-volatile organic compounds

Results: Summarized results from the above analytical tests are shown in the tables below. All metals detected above the individual ion limit of quantification (LOQ) and blank samples are reported. For all other tests only individual compounds above a 0.5μg/mL reporting limit are reported.



Table 6: Summary of VueLife® FEP Semi-Quantification and Identification of Extractables Results

Analytes

Analytical Method

VueLife® C Extractables

Purified Water 70% Ethanol/30% Water

DMSO

Metals ICP/AES 0.02 μg/mL No Metals Detected

No Metals Detected

Volatile Organic Compounds HS GC/MS No Compounds Detected

Semi-Volatile and Volatile Organic Compounds

DI GC/MS No Compounds Detected

Semi-Volatile and Non-Volatile Organic Compounds

LC/UV/MS No Compounds Detected



8 Product Stewardship



Conflict Minerals There is no instance of conflict minerals, as defined by the Dodd-Frank Act, used in the FEP film.

Animal Derivative Content & Transmissible Spongiform Encephalitis (TSE/BSE) Risk

Based on information provided by our suppliers, bovine or other animal derived content materials are not used in the FEP film as defined in specification EMA/410/01 rev.3. The animal derivative content and TSE/BSE risk for the tubing component materials that comprise the different FEP bag and fluid transfer assembly part numbers vary and can be made available upon customer request.

REACH / RoHS Based on information provided by our suppliers, the FEP film is compliant as follows:

RoHS requirements per directives 2011/65/EU, 2002/96/EC, and 2003/11/EC. None of the currently listed

RoHS exemptions are used in the manufacture of this product.

European Union REACH Regulation (EC) 1907/2006, including the current version of the ECHA Candidate

list SVCH compounds.

Proposition 65 Based on information provided by our suppliers, the FEP film is compliant with California Proposition 65



9 General Information



Plant Origin The FEP film used in the manufacture of KryoSure® and VueLife® FEP bags does not contain raw materials that are derived from plants.

Bisphenol A (BPA) BPA is not used in the formulation or manufacture of the FEP film used in the manufacture of KryoSure® and VueLife® FEP bags.

Slip Agents Slips or slip agents are not used in the manufacturing or processing of FEP film used in the manufacture of KryoSure® and VueLife® FEP bags. Slips or slip agents are not used in the manufacturing or packaging process at Saint-Gobain Gaithersburg.

Latex, Gluten, and Allergens FEP bag products do not come in contact with latex materials during the manufacturing or packaging process at Saint-Gobain Gaithersburg. FEP bag product products do not come in contact with allergens as defined by the FDA (Milk, Eggs, Fish, Crustaceans, Soy, Wheat or other Gluten-containing sources, Peanuts and Tree Nuts) during the manufacturing or packaging process at Saint-Gobain Gaithersburg.

Metals with Safety Concern (EMEA/CHMP/SWP/4446/2000) End users must assess the suitability of FEP bag products for their individual applications in the context of the relevant Exposure Limits established by EMEA/CHMP/SWP/4446/2000



10 Disclaimers



Saint-Gobain Life Science Technical Dossiers are intended to provide support for product pre-

implementation end user designs, in-house testing or product selection process. The information is

intended to determine a product’s suitability for use in the end user process, to determine any risks

the product poses to the end user’s product and as the basis for a scientific rationale for the end

users Validation testing.

Saint-Gobain Life Sciences Terms of Use & Confidentiality Statement

PLEASE NOTE: In receiving this Technical Dossier you have agreed to possess ONLY ONE COPY of this

information. You are also agreeing to NOT forward or disseminate, either electronically or in print,

totally or in part, any of the information contained in this material without the express written

consent of Saint-Gobain Life Sciences. If you have any questions about these terms please contact:

[email protected]

mailto:[email protected]



Technical Dossier

VueLife® and KryoSure® FEP Bags

Manual 003, Revision: C Effective: August 3, 2020

Approval Signatures

Role Name Title Signature and Date

Author Jeremy Apelian Quality Manager, Gaithersburg

Reviewer Jonathon Wheatley Product Manager

Revision History

Revision Revision Date Page(s) Affected Revision Description

A 17SEP19 All Original Issue DCR 2019-126

B 25OCT19 10,19,20 Added precautions to page 10, updating page number on table of contacts, corrected GDP errors on 19,20. Changes per DCR 2019-135.

C 17JUN20 10, 11, 15, 16, 17, 19 Provided more detailed intended use statement in alignment with CN-2019-005. Documented particulate removal step prior to welding. Updated CoC, CoA, CoS templates in alignment with CN-2020-001. Streamlined sterilization Validation summary to remove redundant statements. Changes per DCR 2020-045.

vuelife® and kryosure® fep bags

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