PharmaTainer™ Validation Information

PharmaTainer™ Validation Information
Example product drawing from validation file.

Our customers are concerned about biocompatibility and other container quality issues, so Cellon has developed a validation file to assist prospective users of PharmaTainer products. The complete validation file is only available with the completion of a confidentiality agreement.

If you wish to initiate the CDA process, please call 727.437.7777 (Florida office) or drop a note to info@biofluidfocus.com.

What’s In The File

1. General Information
1.1. Product Literature
1.2. ISO 9001-2008 certificate
1.3. Production Overview
2. Specifications (for each container size/material)
2.1. Specification Sheets
2.2. Part Drawings
2.3. Certificate of Compliance (example)
2.4. Batch testing (endotoxin, etc.)
2.5. Packing scheme
3. Resin Information for PET, PC, HDPE
3.1. Resin manufacturer’s data sheet
3.2. Resin manufacturer’s biocompatibility statement  tests specified by the United States Pharmacopoeia or described by ISO 10993
3.3. Cellon’s method of resin identity confirmation & examples
3.4. Material Safety Data Sheets
3.5. Resin manufacturer’s statements regarding freedom from animal derived components (BSE/TSE)
3.6. Resin manufacturer’s statement with respect to RoHS/ELV/REACH-SVHC/CPSIA/Packaging
4. Biocompatibility Testing of Finished Product
4.1. Biocompatibility testing reports, post sterilization
4.1.1. USP VI
4.1.2. In vitro cytotoxicity (MEM)
4.1.3. Indirect hemolysis
4.1.4. Leachable Study
4.1.5. Bioburden and sterility validation
4.1.6. Endotoxin (example of batch testing)
UPDATE Jan. 20, 2014
4.2 Other testing reports, post sterilization
4.2.1 USP <788>
4.2.2 Seal integrity testing (ambient)
4.2.3 Seal Integrity testing at -80°C
4.2.4 1.1M Drop Test at -80°C (10L PC carboy)
5. Chemical resistance information

Product literature and Specifications (section 2.X) are available without a CDA.

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