Sterile compounding is a critical practice in pharmacy that involves the preparation of medications in a sterile environment to prevent microbial contamination. It's essential for producing preparations that will be administered directly into body sites where sterility is crucial, such as intravenous medications, injections, and some ophthalmic and inhalation preparations.

Sterile compounding is crucial in healthcare, especially in hospitals and certain specialty pharmacies. It allows for the customisation of medications for specific patient needs, providing doses, concentrations, or medications that might not be commercially available. However, the critical nature of these preparations means that there's no room for error, and strict adherence to guidelines and best practices is essential.

Key Aspects of Sterile Compounding:

1. Environment: Sterile compounding is typically conducted in a controlled environment like an ISO-certified cleanroom or within a laminar airflow workbench or a compounding aseptic containment isolator.

2. Technique: Proper aseptic technique is crucial. This includes practices like hand hygiene, wearing sterile gloves, gowns, masks, and hair covers, and ensuring that all equipment and ingredients are sterile.

3. Training: Pharmacy personnel involved in sterile compounding should undergo regular training and competency assessments to ensure that they understand and adhere to required standards and techniques.

4. Quality Control: This includes regular testing of the environment for microbial contamination, testing of the compounded preparations for sterility, and other quality measures.

5. USP Chapter 797: In the United States, the United States Pharmacopeia (USP) Chapter 797 provides guidelines and standards for compounding sterile preparations. It covers areas like facility design, staff qualifications, and quality assurance procedures.

6. Risk Levels: Sterile compounding can be categorised based on risk levels:

   - Low Risk: Compounding using sterile ingredients and standard aseptic techniques in a sterile environment.

   - Medium Risk: Compounding that involves multiple doses or combining medications for more than one patient.

   - High Risk: Compounding with non-sterile ingredients or using non-sterile devices before the final sterilization process.

7. Beyond-Use Date (BUD): The date until which the compounded medication is expected to remain stable and sterile. BUDs for sterile preparations are generally shorter than commercial medications due to the lack of preservatives and the potential for contamination during the compounding process.

8. Preparation: Before compounding, a pharmacist reviews the medication order, verifies the ingredients and calculations, and supervises the compounding process to ensure accuracy and sterility.

9. Storage and Handling: Sterile preparations require special storage conditions, often refrigerated or frozen, and need careful handling to maintain sterility until administration.

We outsource the sterile service to our sister lab in WA, Oxford Compounding, one of the most experienced and comprehensive compounding pharmacies in Australia.