Nalgene® PETG Certified Clean Containers are suitable for pharmaceutical and biotechnology applications requiring the processing and storage of bulk intermediates and critical reagents such as vaccine and protein therapeutic preparations
The packaging is designed for cleanroom applications. The bottle and closure are secured with heat-shrink bands providing a tamper-evident seal and then packaged in cleanroom grade heat-sealed bags to assure product integrity. They are then gamma irradiated to provide a 10-6 sterility assurance level (SAL). Bottles meet the requirements for USP Class VI, EP Modified Abnormal Toxicity Test, are non-cytotoxic, non-pyrogenic, non-hemolytic, and comply with USP <661> physicochemical guidelines.
The materials of construction provide excellent gas barrier properties to minimize pH shifts. The resins used to produce these containers are free of animal derived components (ADCF). The bottle and closure system is guaranteed leakproof, making it suitable for transportation applications.
Certifications: Manufactured in a certified ISO 14644-1 Class 7 cleanroom, these containers are lot certified to comply with particulate limits specified in USP <788>, EP 2.9.19 and JP 14th edition Part 1 Section 24.