微生物检验 方法适用性试验计画书 the protocol of microbiological .doc

微生物方法計畫書 Microbiological Examination Method Suitability For Non-sterile Products 目的： Purpose 本計畫書制訂之目的乃是微生物方法適用性試驗計畫。The purpose of this protocol is to exam the suitability of microbiological examination method used on materials in laboratory. 說明： Statement 2.1 各原料依照USP33版所列之微生物檢驗項目執行方法適用性試驗。material is tested by exam items and methods of microorganisms listed in USP version 33. 2.2 試驗順序依照原料類別。 試驗順序原料類別原料名稱 1 A Lactose Monohydrate Lactose Spray - Dried Corn Starch 2 C Lactose hydrous 3 D Pregelatinized Starch Microcrystalline Cellulose Croscarmellose Sodium 實驗： Experiment 3.1 培養基： Medium M6 Soybean – Casein Digest Agar Medium M9 MacConkey Agar Medium M12 Xylose Lysine Deoxycholate Agar Medium M20 Mannitol Salt Agar Medium M22 Sabouraud Dextrose Agar Medium M25 Cetrimide Agar Medium M26 Soybean – Casein Digest Broth 3.2實驗菌種： Microorganism Staphylococcus aureus Pseudomonas aeruginosa Bacillus subtilis Candida albicans Aspergillus niger 3.3實驗器具： Implement 無菌接種環 Inoculating Loop 9cm 無菌培養皿 9cm Sterile petri dish 15 mL 離心管 15 mL Centrifuge ube 微量吸管 Micropipette 微量吸管尖 Tip 3.4實驗設備： Appliance 精密電子天秤 Electronic Balance 生物安全櫃 BSC 恆溫培養箱(32.5 ± 2.5℃) Incubator(32.5 ± 2.5℃) 震盪器 Vortex 3.5實驗步驟： Test steps： 檢品配製Preparation of the sample 可溶於水之產品─以Buffered Sodium Chloride-Peptone Solution pH 7.0，Phosphate Buffer Solution pH 7.2 或 Soybean-Casein Digest Broth溶解待測產品(通常稀釋為1/10)。(usually a 1 in 10 dilution is prepared) the product to be examined in Buffered Sodium Chloride-Peptone Solution pH 7.0, Phosphate Buffer Solution pH 7.2 or Soybean-Casein Digest Brot