Thermo Fisher Scientific has introduced Thermo Scientific Nalgene certified clean PETG containers.
The 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 containers provide gas barrier properties to minimise pH shifts.
Resins used to produce these containers are said to be free of animal-derived components.
The bottle and closure system is claimed to be leak proof, making it suitable for transportation applications.
The Nalgene bottles are manufactured in a certified ISO 14644-1 Class 7 clean room.
The 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).
The packaging of the Nalgene certified clean PETG containers is designed for clean-room applications.
Bottle and closure are secured with heat-shrink bands providing a tamper-evident seal and then packaged in clean-room-grade heat-sealed bags.
They are then gamma irradiated to provide a 10-6 sterility assurance level.
Products meet the requirements for USP Class VI and EP-modified abnormal toxicity tests, are non-cytotoxic, non-pyrogenic and non-hemolytic and comply with USP <661> physicochemical guidelines.
