An interesting article appeared in the March/April issue of the Parenteral Drug Association’s (PDA) Journal of Pharmaceutical Science and Technology. We are summarizing this article for our clients who manufacture their own patient prescriptions. The article, entitled, “Evaluation of Disinfecting Procedures for Aseptic Transfer in Hospital Pharmacy Departments”1 sheds some light on pharmacy operations and is valuable for anyone who wants to excel in their preparation of patient injections.
Everyone who compounds prescription medication is familiar with the risks of accidentally contaminating the product with bacteria from the environment; bacteria which may lead to skin infections or sepsis. So we all disinfect our work areas in an attempt to exclude the bacteria from getting into the vials. But what type of procedure should we follow to get the best results? In an earlier newsletter, we outlined the requirements of USP <797> as applicable to the practice of allergy.
The JCAAI developed industry guidelines based on the USP recommendations, that are important for allergists to follow. One aspect of these guidelines concerns the demonstration of disinfection of mixing surfaces.
Additionally, the USP discusses the prevention of microbial contamination. Together, these recommendations demonstrate a concern for environmental control.
Allermed employs dedicated personnel to clean and disinfect the Prescription Compounding area each night prior to work. We use phenolic disinfectants, and rotate their use each week between an acidic and a caustic formulation. Every two weeks we use a sporicide to disinfect the area to ensure that no resistant organisms survive. This is a complex process, and may not be necessary for your facility. But we understand that bacteria have evolved to survive under some of the most stressed conditions on the planet, and it takes more than one disinfectant type to remove them all to ensure none end up in your prescription vial.
The PDA article we reviewed tested some of the more common disinfectants used in a pharmacy operation.
- Test Disinfectant
- QUAT /Chlorine dioxide
- 6% Hydrogen peroxide
- Amphoteric surfactant
- 70% v/v denatured ethanol with deionised water
- 70% IPA with water for injection
- Sterile distilled water (control)
1Mehmi, M., Marshall, L., Lambert, P., and Smith, J.C., Evaluation of Disinfecting Procedures for Aseptic Transfer in Hospital Pharmacy
Departments, PDA J. Pharm. Tech., Vol. 63, No. 2, March/April 2009, pp. 123 – 138.