Everything you need to know about Sterile Compounding , all your questions answered.
Kingsway Compounding is a state of the art, purpose-built clean room facility. Our dedicated Compounding Pharmacy accommodates multiple clean rooms, catering for:
- Bioidentical Hormone Replacement Therapy (BHRT)
- Personalised Nutritional Compounds
- Sterile Aseptic compounds.
Our Clean room is built to the highest specification with a Class C (ISO 7) rating together with a Class A (ISO 5) sterile work area. Our technology enables us to constantly monitor our clean rooms for the optimum temperature, pressure and humidity.
Pressure control assures there is no cross-contamination between the different laboratories. We have one laboratory for nutrition, one laboratory for making hormones, one laboratory for making sterile compounds and one laboratory for making creams and liquids.
In the case of our sterile compounds, we test for potency, stability, sterility and endotoxin. Critical parameters to ensure a consistent, safe, sterile compound. As part of our quality control procedures, we have a very thorough record-keeping process. Kingsway Compounding keeps track of:
- Who makes the compound
- Manufacturers supplying the raw materials
- Batch numbers
- Expiry dates
We're able to access this material immediately, at any time should there be any queries with any of our compounds.
As part of our ISO certification and Good Compounding Practice, we test all our raw materials to validate their quality when compounding your medicine.
Frequently Asked Questions:
1. What is sterile compounding?
Sterile compounding involves creating a medicine that is free from contamination and potentially infectious microorganisms minimising any potential harm to the patient as a result.
2. Why are some compounded medications required to be sterile?
Compounding for medications that will be administered either through an IV [intravenous], injection, or directly into the eyes require sterilisation. Administering medications through these routes have a very high risk of causing infection. Sterile compounding techniques significantly reduces such risk.
3. What to expect from your sterile compounding pharmacy?
Pharmacies that practice in accordance with the Australian compounding regulation. These procedures and techniques include:
- Suitably qualified staff specifically trained in Sterile compounding techniques.
- Validation of all sterile processes to ensure consistent quality sterile products.
- Appropriate laboratory facilities designed specifically to minimise contamination.
- Correct use of personal protective equipment (PPE). This includes gloves, goggles, masks, and hair coverings.
- ISO V Certified Laminar Flow Cabinet to maintain a sterile environment.
- Sterilised equipment, such as flasks, beakers, spatulas, and syringes.
- Validate cleaning procedures to eliminate any cross contamination.
4. What types of pharmacies will perform sterile compounding?
Pharmacies with an inbuilt clean room facility with a Class C (ISO 7) rating together with a Class A (ISO 5) sterile work area are able to perform sterile compounding. Pharmaceutical industries use a term "sterility assurance level" as a benchmark for acceptable sterility in aseptic manufacturing. Without a clean room facility this industry standard will not be met and compounding medicines are deemed contaminated and unsafe for patient use/consumption.
Since February 2018, pharmacists who compound sterile injectable medicines must ensure compliance with the guidance in their practice. The guidance advises pharmacists to choose and adhere to one of the following standards most relevant to their compounding practice:
- PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010)
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009)
- USP–NF〈797〉Pharmaceutical Compounding—Sterile Preparations.
- APF and Handbook 25th Edition - The Australian Pharmaceutical Formulary