Facilities & Services

Oxford Compounding operates separate non-sterile and sterile laboratories at our North Perth premises. The sterile suite is purpose-built: a classified cleanroom with laminar airflow cabinets, pressure-cascaded ante-areas, HEPA-filtered air and controlled gowning procedures, supported by a dedicated preparation and quarantine area.

USP 797 compliance requires that the preparation of sterile pharmaceuticals occurs in an ISO Class 5 (Class 100) environment, within a buffer area of ISO Class 7 (Class 10,000), plus ante-areas of at least ISO Class 8 (Class 100,000). Our facility is built and monitored around these classifications.

• ISO Class 5 laminar airflow workstations for aseptic preparation
• ISO Class 7 buffer room with ISO Class 8 ante-area and gowning zone
• HEPA filtration with pressure differential monitoring
• Separate non-sterile laboratory for creams, capsules, troches and liquids
• Controlled storage including refrigerated and temperature-logged areas
• Dedicated analytical and quality documentation workspace

• Operator aseptic technique validated through routine media fills
• Master formulation records and per-batch manufacturing records
• Ingredient traceability from approved, documented suppliers
• Deviation and out-of-specification investigation procedures
• Pharmacist release review before any preparation is dispatched
• Practices aligned to TGA and Pharmacy Board compounding standards