Manufacture
Liquids, capsules and semi-solids made in Grade C suites, from development batches to full commercial scale.
The facility
Australian GMP manufacturer
Medicines made to a standard you can check.
Corvane manufactures, tests and releases prescription medicines in a TGA-licensed facility in Western Sydney. Every batch is measured against its specification and released only when every result sits inside its limits.
TGA GMP licence [placeholder]ISO 7 cleanroomsReleased in Australia
| Peak | RT, min | Area % |
|---|
1,240batches released since 2009To 30 June
2,600m²of ISO 7 and 8 cleanroomGrade C and D
38tests on a typical batch recordBefore release
96people in SydneyQuality, production, science
What we do
From raw material to released batch, under one roof.
We work for pharmaceutical companies that need an Australian manufacturer: formulation, filling, testing and release, with the paperwork a regulator expects.
Quality control
An in-house lab for chemistry and microbiology: identity, assay, impurities, stability and release testing.
How we testPack and supply
Serialised packing, cold-chain storage and supply to licensed wholesalers and pharmacies only.
Supply enquiriesBatch release
Nothing leaves until every result is in.
A batch record holds every test the batch must pass. Our authorised person reviews it line by line, and only then signs the release.
Batch recordProductCL-2611-04AX-10 · 10 mL
- AppearanceVisualConforms
- IdentificationHPLC, RT matchConforms
- Assay95.0–105.0 %99.1 %
- Related substances≤ 1.0 % total0.21 %
- Microbial countTAMC ≤ 10² cfu/mL< 10
- Fill volume10.0–10.5 mL10.2 mL
Reviewed and released byAuthorised personSample record for this template
| Test | Result | Within specification |
|---|---|---|
| Assay | 99.1 % | |
| Related substances | 0.21 % | |
| Fill volume | 10.2 mL | |
| pH | 6.4 |
About the samples on this page. Product codes, results and the batch record are illustrations. They don't describe a real medicine.
- Sample
Retained and test samples drawn to the plan.
- Test
Chemistry and micro run in our own lab.
- Review
Every result checked against its limit.
- Release
The authorised person signs the batch.
- Retain
Records and samples kept past expiry.
The facility
Air that only flows one way.
Rooms step down in pressure from the filling suite to the corridor, so air always moves from cleaner to less clean. Every door, differential and particle count is logged.
- Filling suite
- +45 Pa · Grade C
- Airlock
- +30 Pa · Grade C
- Gowning
- +15 Pa · Grade D
- Corridor
- 0 Pa · Controlled
Investors
Announcements, as they're lodged.
Reports, presentations and market announcements, newest first. Price-sensitive announcements are marked.
Careers
Careful work, done by careful people.
Analysts, operators, engineers and quality people who like knowing exactly why a number is what it is. Six roles open in Sydney.
Work with Corvane
Bring us a product. We'll bring the evidence.
Technology transfer, clinical supply and commercial manufacture. Tell us what you make and the volumes you need, and our business development team replies within two working days.