初始污染菌校正因子的测定报告(国外英文资料).docVIP

初始污染菌校正因子的测定报告(国外英文资料) Shenzhen McCollin technology co., LTD Initial contamination correction factor confirmation report The document number: ___________ Edition: ___________ Controlled state: ___________ The distribution number: ___________ Possession department: ___________ 2010-06-03 released 2010-06-10 Preparation: check, approve: catalogue 1 overview 2 confirmed on the basis of 4 the validation process The preparation of the lotion Preparation of nutrient AGAR medium 3.3 the vaccination 3.4 develop 3.5 colony count The calculation of the correction factor 6 confirmation conclusion To confirm 1 overview The companys initial pollution test guide book is used to describe the living microorganism in the product. Bacteria but accurately determine is impossible, therefore, in practice, the correction factor will live bacteria counting bacteria into product evaluation, this factor is used to compensate the elution efficiency. confirmations ISO 11737.1-2006 the microbiological approach of the microorganism of the medical device: the determination of the total number of microbes in the product. Three confirmation process Preparation: 3.1 the eluent were selected three new preparation of the sample of the disposable blood collection needle, cervical swab sampling, the purification worktable, with a sterile scissors cut up, each sample weighing, put in the sterilization in advance with triangle in a bottle, add about (sample weight x 10 ml of pH7.0 sodium chloride - peptone sterilization eluent, stoppered, fully, to make the sample fully elution, and then transfer the eluent to another sterile with triangle in the bottle, immediately cover and set aside. Nutrient AGAR culture medium preparation: 3.2 products will be commercially available nutrient AGAR medium preparation according to specifications, and then in 121 ℃ high pressure steam sterilizer sterilization within 15 min, in around 50 ℃ water bath. Set aside. 3.3 vaccination: in purification worktable, use transfer p