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(Used for Compounding Medications)
Thanks for all the input this past week after the publication of last Friday's newsletter. It generated the needed response to address this situation. The issue is widespread and confusing, but now there are filter companies, pharmacists, and others that are addressing the problem�but it will take some time.
It has been found that different personnel in the same company may have different opinions and actually all may be correct in what they say because of different applications, volumes to be filtered, etc. All agree that it is a very unfortunate and unsettling situation we find ourselves in, and we are working to get it clarified. So please, ignore the categories from last weeks' newsletter.
The USP Pharmacy Compounding Expert Committee should consider addressing this for an immediate change in the currently official <797>; such immediate changes have been made in the past.
In the interim, a reasonable approach may be to look at the requirements for filters used to sterilize drug preparations for human use and compare these with the documents received (Certificates of Analysis or other documentation) from the filter companies.
If the filters have received a 510K approval, they have essentially been approved for human use.
The following are sterile filter standards from USP <797>:
- Sterile filters used to sterilize compounded sterile preparations (CSPs) shall be pyrogen free and have a nominal pore size of 0.2 or 0.22 mm.
- They shall be certified by the manufacturer to retain at least 107 microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta on each square centimeter of upstream filter surface area under conditions similar to those in which the CSPs will be sterilized.
- The compounding supervisor shall ensure, directly or from appropriate documentation, that the filters are chemically and physically stable at the pressure and temperature conditions to be used, that they have enough capacity to filter the required volumes, and that they will achieve sterility and maintain prefiltration pharmaceutical quality, including strength of ingredients of the specific CSP.
- The filter dimensions and liquid material to be sterile-filtered shall permit the sterilization process to be completed rapidly, without the replacement of the filter during the process.
- When CSPs are known to contain excessive particulate matter, a prefilter of larger nominal pore size membrane is placed upstream from the sterilizing filter to remove gross particulate contaminants in order to maximize the efficiency of the sterilizing filter.
- Filter units used to sterilize CSPs shall also be subjected to manufacturers' recommended integrity test, such as the bubble point test.
- Compounding personnel shall ascertain that selected filters will achieve sterilization of the particular CSPs being sterilized.
- Large deviations from usual or expected chemical and physical properties of CSPs (e.g., water-miscible alcohols) may cause undetectable damage to filter integrity and shrinkage of microorganisms to sizes smaller than filter nominal pore size.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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