Oxoid CM1016B GAMMA IRRADIATED TSB
GAMMA-IRRADIATED TRYPTONE SOYA BROTH (GAMMA-IRRADIATED TSB)
CODE: CM1016
A general, nutritious medium for the cultivation of a wide range of organisms which has been given a sterilising dose of irradiation. Gamma-Irradiated TSB is particularly suitable for the microbiological validation of aseptic filling (Media Fill Test).
一种通用的、有营养的培养基,用于培养各种生物体,并经过一定剂量的辐照处理。 伽马辐照 TSB 特别适用于无菌灌装(培养基灌装测试)的微生物验证。
Formula |
gm/litre |
Pancreatic digest of casein |
17.0 |
Papaic digest of soybean meal |
3.0 |
Sodium chloride |
5.0 |
Dibasic potassium phosphate |
2.5 |
Glucose |
2.5 |
pH 7.3 ± 0.2 |
Directions
Method 1
Suspend 30 gms in 1 litre of sterile distilled water. Mix well to dissolve. Use for liquid-fill validation procedures.
Method 2
Use powder for dry-fill validations procedures. Ensure that the final concentration of the medium is 30 gms of Gamma-Irradiated TSB suspended in 1 litre of sterile distilled water. Mix well to dissolve.
If required the medium may be prepared by autoclaving. Suspend 30 gms in 1 litre of distilled water. Mix well to dissolve. Dispense into containers. Sterilise by autoclaving at 121°C for 15 minutes.
方向
方法一
将 30 克悬浮在 1 升无菌蒸馏水中。 充分混合溶解。 用于液体填充验证程序。
方法二
使用粉末进行干式填充验证程序。 确保培养基的最终浓度是 30 克伽马辐照 TSB 悬浮在 1 升无菌蒸馏水中。 充分混合溶解。
如果需要,可以通过高压灭菌来制备培养基。 将 30 克悬浮在 1 升蒸馏水中。 充分混合溶解。 分装到容器中。 通过在 121°C 高压灭菌 15 分钟进行灭菌。
Description
Gamma-Irradiated TSB is particularly suitable for sterility testing and for the validation of aseptic filling procedures. In the Media Fill Test (MFT), a validation method used to assess the performance of aseptic processing in the pharmaceutical industry, pharmaceutical products are substituted by sterile powder, such as Gamma-Irradiated TSB. The medium is subjected to exactly the same conditions as the product, including filling and closing, to ensure that there is no microbial contamination occurring during the process.
The powder is readily soluble in sterile water, either as part of or at the end of the procedure, then incubated for detection of any organisms present. The use of Gamma-Irradiated TSB simplifies media preparation for MFTs and other applications, and is less time consuming, since it eliminates the need for in-house media sterilisation prior to use.
Gamma-Irradiated TSB is treated at an irradiation level of 40 kGy, as recommended by Annex B of the ISO 11137 Standard1 to ensure the absence of viable vegetative cells and bacterial spores whilst achieving minimal reduction in performance. Quality control testing is carried out before and after irradiation to carefully monitor performance and to check the sterility of the final product. Gamma-irradiation at higher levels, as used by some manufacturers, has been shown to reduce fertility of the medium2.
The formulation of the medium conforms to a range of recognised standards; British Pharmacopoeia Volume II 2000 + Amendment No.1, United States Pharmacopoeia 24 NF19 + 3rd Supplement, European Pharmacopoeia 3rd Edition 2000 + Supplement 2001, Japanese Pharmacopoeia 12th Edition + Supplement II JP XIII.
描述
伽马辐照 TSB 特别适用于无菌测试和无菌灌装程序的验证。在介质填充测试 (MFT) 中,一种用于评估制药行业无菌加工性能的验证方法,药品被无菌粉末替代,例如伽马辐照 TSB。培养基经受与产品完全相同的条件,包括灌装和封口,以确保在此过程中不会发生微生物污染。
作为程序的一部分或在程序结束时,粉末很容易溶于无菌水中,然后孵育以检测存在的任何生物。伽马辐照 TSB 的使用简化了 MFT 和其他应用的介质制备过程,并且耗时更少,因为它无需在使用前对内部介质进行消毒。
按照 ISO 11137 标准附录 B 的建议,伽马辐照 TSB 在 40 kGy 的辐照水平下进行处理,以确保不存在活的营养细胞和细菌孢子,同时最大限度地降低性能。在辐照前后进行质量控制测试,以仔细监控性能并检查最终产品的无菌性。一些制造商使用的较高水平的伽马辐照已被证明会降低培养基的生育能力2。
培养基的配方符合一系列公认的标准;英国药典第 II 卷 2000 + 第 1 修订版,美国药典 24 NF19 + 第 3 增补,欧洲药典第 3 版 2000 + 增补 2001,日本药典第 12 版 + 增补 II JP XIII。
Storage conditions and Shelf life
Store the dehydrated medium at 10-30°C and use before the expiry date on the label.
Appearance
Dehydrated Medium: Straw coloured, free flowing powder.
Prepared medium: Straw coloured solution.
Quality control
Positive controls: | Expected results |
Streptococcus pneumoniae ATCC® 6305 * | Turbid growth |
Staphylococcus aureus ATCC® 25923* | Turbid growth |
Negative control: | |
Uninoculated medium. | No change |
* This organism is available as a Culti-Loop®
References
1. Annex B of the ISO Standard 11137 ‘ Sterilization of health care products – Requirements for validation and routine control – Radiation Sterilization. International Organisation for Standardization Case Postale 56, CH-1221 Geneve 20, Swtzerland (1995)
2. Data on file at Oxoid (2002)
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