Thermo Fisher Scientific has introduced a range of certified clean PETG containers, which 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 company says the Nalgene containers provide excellent gas barrier properties to minimise pH shifts.
In addition, the resins used to produce these containers are free of animal derived components (ADCF) and the bottle and closure are guaranteed leakproof.
The containers are manufactured in a certified ISO 14644-1 Class 7 cleanroom and lot certified to comply with particulate limits specified in USP <788>, EP 2.9.19 and JP 14th edition Part 1 Section 24.
The bottle and closure are secured with heat-shrink bands that provide a tamper-evident seal and then packaged in cleanroom grade heat-sealed bags to assure product integrity. Gamma irradiation then provides a 10-6 sterility assurance level (SAL). Products meet the requirements for USP Class VI, EP Modified Abnormal Toxicity Test. They are non-cytotoxic, non-pyrogenic and non-hemolytic, complying with USP <661> physicochemical guidelines.