There may be variety of changing regimes within a pharmaceutical factory. It is noted that no two factories exhibit identical regimes. These regimes will vary for a number of reasons including historically accepted practice and the design of the facility. It is the intention of this guide to identify Best Practice and to describe the appropriateness of a particular practice. […]
Discover expert strategies for the Design Of Garment Changing Facilities for Pharmaceutical Facilities to ensure compliance and efficiency.
Developing a local SOP is giving a detailed description of the requirements for disinfectant efficacy testing and validation of the method is extremely important, for which various methods can be used, which are given below. Test Method – The Time Contact Test The test will demonstrate the ability of the disinfectant to kill or inhibit a large population of organisms […]
It is generally accepted that although the Time-Contact Test provides good evidence for the activity of a particular agent, the method does not take into account the physical factors that may effect the performance of the agent when applied to actual surface materials such as Stainless Steel, Vinyl, Ceramics, PVC, Perspex, Glass. There are a number of factors that may […]
Did you know about 70% of pharmaceutical products use purified water? This shows how important purified water system validation is for secondary pharmaceutical firms. It ensures product quality and safety. The industry follows strict rules, making validated systems a must for public health. This article will dive into why validation is key in the pharmaceutical world. It focuses on secondary […]
Explore the difference between HEPA and ULPA filter technology to discern which suits your air purity needs better. Unveil their efficiency levels and specifications.
In some facilities the requirement to control disinfectants on receipt via the Incoming Materials QA system is interpreted in part as a requirement to perform bioburden testing on undiluted disinfectants. In some sterile facilities it is the practice to sample from containers of in-use sterilized disinfectant solutions which are nearing their expiry date. For non sterile facilities it is recommended […]
A new disinfectant should not be recommended to manufacturing centers without performing efficacy work and ensuring that its effectiveness is equivalent to or better than current agents. A rationale report is required to document the reasons for introducing a new disinfectant. The following guidelines should be used as a basis for identifying a suitable disinfectant. The disinfectant should have no […]
The effectiveness of proprietary disinfectants may be established by reference to supplier information. This is the minimum requirement for any organization. Its application must be considered carefully for each disinfectant in each local operating company. The general antimicrobial activities of the active components of proprietary disinfectants are invariably well known, and if supplier information is to be used it must […]
The use of disinfectants within sterile facilities, particularly the critical areas such as grade A/B areas, requires some additional precautions. For example, solutions will need to be filtered into the aseptic filling area through sterile 0.2µ membrane filters. However the general principles outlined in previous sections still apply, using the same disinfectants, controls in separation and rotation of agents. The […]
