To achieve sterility assurance, we first categorize products based on their characteristics and determine the appropriate ranges for each type of product, such as Cell Culture Plates and Cell Culture Dishes. Each type of product is an respective range.
Irradiation dose determination in the third-party CNAS laboratories
We will send representative samples from each range to authoritative third-party CNAS laboratories (CNAS laboratory refers to the laboratories which have been accredited by the China National Accreditation Service for Conformity Assessment.) to determine the minimum sterilization dose required to reach the sterility assurance level SAL=10-6(i.e. the chance that there may be live microorganisms in one million products is 1, which is consistent with GMP requirements), in accordance with ISO 11137 standards.
PQ (performance qualification) to ensure effectiveness
With the minimum irradiation dose, a performance qualification (PQ) will be conducted to ensure that the sterilization dose is acceptable throughout the case, and to make sure the minimum irradiation dose qualified via current packaging solutions.
Regular dose inspection for quality assurance
Regular dose inspection is done every 3 months for quality assurance, and a new PQ is conducted in the case that the packaging solution is changed. The annual dose inspection is done in the next year only when the previous four inspections are finished.
Irradiation certificate in provision
Irradiation certificate will be offered by the irradiation center for each batch of product sterilization .
Third-party CNAS laboratory testing
We conduct a 3-year accelerated aging test on representative samples of each product family to evaluate the 3-year effective shelf life of the packaging by conducting sterility testing, vacuum leak testing, dye testing, and sealing performance testing before and after the accelerated aging. The testing report is issued by an authoritative third-party CNAS laboratory.
Ensuring Sterilization Effect of Each Batch
The irradiation center decides the distribution of the irradiation dose on the products according to the set dose, ensuring that the irradiation adsorption is within the set range and forms specific irradiation processes. During batch irradiation, the irradiation processing is carried out according to specific irradiation standards, with a dosimeter additionally placed at the beginning and end of the production batch for monitoring. If the dosimeter returns a proper value, we consider that the sterilization dose of all products qualified. The irradiation dose of the batch is verified in this way, and relevant irradiation certificates will be issued.
Company qualifications
The entire range of sterilization for products produced by Wuxi NEST Biotechnology Co., Ltd. is handled by its subsidiary, Wuxi Futeng Radiation Technology Co., Ltd. Both companies are located in the Xida Road, Meicun Industrial Park, Xinwu District,Wuxi, achieving seamless integration of the "product manufacturing-packaging-sterilization" process.
Batch Irradiation Flow Chart
Wuxi Futeng Irradation Technology Co., Ltd.
NEST imported a full set of Rhodotron TT200 (10 MeV electron beam,Beam flow 5 mA, 50kW/100kW) from IBA Industrial with automatic flipping over function.
