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Sartorius gives reliable extractables profiles, figuring out all relevant chemical entities. We have identified more than ninety five% of all compounds through the Sartorius consumables portfolio.

建立有据可循的 书面协议（created protocols）和 预期结果（envisioned outcomes）对于工艺确认非常重要。书面协议应包括 生产条件（production situations）、 数据收集（data collections）、 测试（testings）和 取样计划（sampling designs）。

Temperature and relative humidity shall meet the need as laid out in the system specification.

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制造安全优质的医药产品需要良好的制造工艺。简单地说，这就是工艺验证的目标，即确保药品始终符合质量标准。实现这一目标的方法是通过工艺验证的三个阶段。

Sartorius has furnished validation expert services for the biopharmaceutical field for much more than 25 years. We've a deep knowledge of the regulatory landscape and have a consultative solution along with you.

one bit of information. So, from the validations we can operate with two official message kinds, declared in

Water sampling and screening need to be completed for two to 4 weeks to watch the water system. Through this period, water system more info should read more really run continually with no failure. Next points must be considered during this phase.

Comparison of Extractables Protocols It can be Sartorius’ target to supply you with the most in depth extractables data probable to simplify their process qualification and validation.

This contributes to the curious observation that the consequences of an error will often be a lot more significant that the

method, we could formalize the example specification in this kind of way that we can prove conclusively In case the

Crucial and non-vital parameters must be based on indicates of a Threat Evaluation (RA) for all HVAC set up components, subsystems and controls. Our workforce of authorities is specialised for undertaking HVAC qualification actions, which includes structure and development of tailor made VALIDATION AND QUALIFICATION DOCUMENTATION and execution of all actions, together with documented measurements of vital HVAC system parameters, which include: Classification of air cleanliness by particle concentration

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