防腐功效测试
进行防腐剂测试以确定令人满意保存所需的防腐剂的类型和最低有效浓度pharmaceuticals，，，，食物和生物技术产品。在最终包装产品中有效的防腐剂应大大低于可能对人类有毒的防腐剂浓度。
The Preservative efficacy test is a laboratory test that determines the level of antimicrobial activity of a product and to evaluate how well a product withstands microbial contamination during use. Preservative efficacy test is an important parameter for both pharmaceutical and food products where there is higher risk of microbial contamination.
什么是防腐剂，为什么使用它们？
Preservatives are substances added to non-sterile preparation in order to protect them from unwanted microbial growth or from microorganisms which are unknowingly introduced during manufacturing process. The primary purpose of adding antimicrobial preservatives to dosage forms is to prevent adverse effects arising from contamination by microorganisms that may be introduced inadvertently during or subsequent to the manufacturing process. In the case of sterile articles packed in multiple-dose containers, antimicrobial preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses.
防腐剂功效测试可用于对产品的稳定性研究，以确定防腐剂在保质期内的有效性。它也用于检查配方的鲁棒性。
Principle of Preservative Efficacy Test
防腐功效测试的原理是接种具有微生物的产品，然后在定义的时间间隔内评估产品，以查看微生物种群是否减少，在给定时间内为所需的水平减少。必须在防腐剂疗效测试之前或在parell中进行中和对防腐剂的中和研究，以确保中和生物活性剂的中和，如果中和研究失败，则必须使用替代的中和方法，例如膜过滤。
如果降落或没有增加的微生物数量，则将产品的防腐性质视为足够的。指定用于测试的生物旨在代表可能在制造，存储和使用制剂的环境中发现的生物。该测试也考虑了与制造一侧的环境分离株。
Arbro Pharmaceuticals Limited（分析部门）是一个多学科的合同研究和测试组织，是政府批准的实验室，拥有多年的经验，与各个行业和世界各地的总理客户合作。Arbro拥有完整的Micro Lab，并在其德里和Baddi设施中拥有所有必需的设施。Arbro拥有一支由尖端技术和世界一流的基础设施支持的200多名专业人员的团队，Arbro是所有微生物学测试要求的最佳解决方案合作伙伴之一。
Preservative Efficacy recoveries
关于在不同的多蛋白产品中观察到的回收率，观察到，许多产品显示出与药房中提到的值相对更高的日志还原。因此，我们是否应该根据对产品的较高日志减少进行结论，因为还考虑了用于判断防腐剂值的防腐剂或任何其他参数？
Hi Nasrat, Along with the activity the data needs to be supported with quantification of the added preservatives by HPLC or some other technique to establish that it has been added within the permitted levels and is safe for use.
如果对食品和药品进行了测试，是否有任何不同的程序测试程序？
Dear Soh, there are differences in the organisms used between the 2 kinds of products.
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