HEPA vs ULPA Filter: Key Differences to Know
Explore the difference between HEPA and ULPA filter technology to discern which suits your air purity needs better. Unveil their efficiency levels and specifications.
Bioburden Testing Of Disinfectants
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 […]
Selection of a new disinfectant for Secondary Pharmaceutical Facilities
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 […]
Establishing the Effectiveness of Disinfectants in Secondary Pharmaceutical Facilities
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 […]
Use Of Disinfectants in Sterile Facilities of in Secondary Pharmaceutical Facilities
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 […]
Rotation Of Disinfectants in Secondary Pharmaceutical Facilities
It is considered good practice, and is an expectation of many regulatory inspectors, that a routine rotation of disinfectants used in general cleaning and decontamination is in place. The basis of this rotation, is the potential for resistant micro organisms to develop if a single disinfectant is used. Whilst the evidence for this resistance is somewhat anecdotal, the use of […]
Fumigation and Sanitization in Secondary Pharmaceutical Facilities
Fumigation is a process used for rooms, safety cabinets or enclosed spaces (e.g. isolators, tents) using gases or finely dispersed sprays. The objective may be decontamination of the room or machinery/equipment within the space or both. Generally fumigation has been used for sterile product or other clean product environments although there are other applications such as animal houses. In the […]
Preparation and Control of Disinfectants in Secondary Pharmaceutical Facilities
The importance of control of disinfectants approval of incoming materials and preparation of solutions to be controlled. The effectiveness of the various disinfectants can be significantly decreased if their preparation as solutions and subsequent control is not properly performed. The issues which should be considered are: a) Correct dilution of the disinfectant b) Use of adequately controlled diluents c) Sufficient […]
Uses and Limitations of Disinfectants in Secondary Pharmaceutical Facilities
With such a wide range of available disinfectant agents it is not surprising that they have different effectiveness and are used in different locations depending on their properties. Several factors can affect the effectiveness of the agent, including a) Dilution specific concentrations are usually needed. Higher concentrations are NOT always more effective. The suppliers recommendations should be followed unless otherwise […]
Categories of Disinfectants in Secondary Pharmaceutical Facilities
Categories: A wide range of disinfectants are in use, offering a range of activities and types of use, and they may be grouped together in a number of broad classifications. These are: a) Alcohols, usually ethanol or Industrial Methylated Spirit (IMS) but also other alcohols such as Isopropyl. They may be used alone or as a solvent for other disinfectants. […]