Nalgene® Certified Clean Containers, Clear PETG, Sterile
Nalgene® certified clean media bottle containers are made of clear PETG plastic and are furnished with a sterile, natural HDPE screw cap closure with a tamper-resistant seal that ensures product integrity prior to use. 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 PETG material exhibits excellent gas barrier properties to ensure pH stability for buffered solutions. The resins used to produce this container are free of animal derived components (ADCF). The bottle and closure system is guaranteed leakproof, making it suitable for transportation applications. 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, then gamma irradiated to provide a 10-6 Sterility Assurance Level (SAL). This bottle meets the requirements for USP Class VI, EP Modified Abnormal Toxicity Test, is non-cytotoxic, non-pyrogenic, non-hemolytic, and complies with USP <661> physicochemical guidelines. Manufactured in a certified ISO 14644-1 Class 7 cleanroom, the container is lot certified for low particulate limits specified in USP <788>, EP 2.9.19 and JP 14th edition Part 1 Section 24.