Sterile Services
Sterile Manufacturing
Batch manufacture of sterile preparations for hospitals, clinics and trial sponsors — produced under validated processes and TGA-aligned quality standards.
Beyond one-off compounding
Where a hospital, clinic network or trial sponsor needs the same sterile preparation repeatedly, batch manufacturing is more efficient, more consistent and easier to document than compounding unit by unit. Our sterile laboratory produces batches of injectables, ophthalmics and irrigation solutions under validated processes, with each batch fully reconciled and released against a defined specification.
- Batch sizes scaled to the customer's ordering pattern
- Master formulation and batch manufacturing records for every product
- Validated aseptic process with routine media fills
- Component and container-closure control from approved suppliers
- Sterility, endotoxin and potency testing where the product requires it
- Certificate of analysis and batch documentation supplied on release
What we manufacture
Quality and compliance
Manufacturing is carried out in the same purpose-built cleanroom suite as our sterile compounding, under continuous environmental monitoring. Processes, cleaning and operators are validated, deviations are investigated and documented, and each batch is reviewed before release by a responsible pharmacist.
Our practices are aligned with Therapeutic Goods Administration manufacturing principles and current Pharmacy Board compounding guidelines. Regulation in this area changes regularly and we actively review and improve our systems to stay compliant.
Working with us
- Share the formulation, strength, container and volumes required
- We confirm feasibility, stability data needs and testing requirements
- Trial batch produced and reviewed with you before routine supply
- Scheduled production and delivery aligned to your ordering cycle
Tell us the preparation, volumes and timelines, and our team will scope feasibility, testing and supply schedule.