We provide specialized sterilization and depyrogenation services tailored to the specific needs of pharmaceutical and medical manufacturers. Steam and dry heat sterilization, Depyrogenation, and Rinsing services for small and mid-sized batches. We handle the complexity and compliance, for you to focus on your core business.
1. Steam Sterilization (Autoclave)
Avoid the heavy investment in your own autoclave systems. We offer high-capacity steam sterilization of pharmaceutical glassware that fully meets regulatory requirements, but with the flexibility that small production runs require.
2. Dry Heat Sterilization
3. Depyrogenation
4. Validated Rinsing Processes
Our advanced dry sterilization is the ideal solution for your glass components. By outsourcing this process to us, you eliminate the need for specialized maintenance and validation of your own ovens.
Safeguard your injectable products with our validated depyrogenation processes. We effectively remove pyrogens from your bottles and containers, giving you a "ready-to-fill" solution meeting your specific needs for filling facility and process.
A clean production starts with a perfect washing. We provide validated washing of primary packaging, followed by a final WFI rinsing to ensure extremely low particulate and endotoxin levels prior to sterilization. This reduces your risk of contamination and saves you valuable square footage in your own production.
Our specialized sterilization and rinsing processes are optimized for a wide array of primary packaging formats, ensuring maximum flexibility for your production. Whether you are working with standard vials, sensitive amber glass, or large-volume infusion bottles, our facility is optimized to handle your niche production with the highest degree of compliance.
We provide full-service processing of glass vials and infusion glass bottle in a wide range of formats to ensure your products are "ready-to-fill" or "ready-to-use" with a high compliance standard.
Full-service processing of standard clear vials in sizes:
2ml, 5ml, 10ml, 20ml, 30ml, 50ml, 100ml, 500ml, up to 1,000ml.
Photo by Sterillab.
Expert in handling of small Type 1 amber glass vials, ideal for light-sensitive products such as eye drops and other specialized pharmaceuticals.
Designed for child-resistant tamperproof lock mechanism, both for snap and screw caps. Option to include a mounting device to secure optimal mount of snap.
Size: 10ml
Photo by Sterillab
Capacity to process larger infusion bottles, maintaining integrity and sterility across higher volumes.
Sizes: 100ml, 500ml, and 1,000ml
Photo by Sterillab
When sourcing amber bottles, caps, and dropper mechanisms individually, the risk often lies in assembling from i.e. three different sources with each one having their defect rates (AQL). Thus, each component has its own AQL, which often adds up to a relatively high cumulative defect rate if assembled in your own line.
To eliminate this risk and protect your fill-finish process, Sterillab handles the complete component sourcing, inspection, and cleanroom assembly. By filtering out deviations before and during assembly, our target for a final defect rate is be under 1% on the ready-to-fill units delivered to your facility.
We understand that small and mid-sized manufacturers require agility. Our production lines are designed to adapt to your specific batch sizes without the long lead times, which is often associated with larger facilities.
To meet your expectations and needs, please provide your project assessment.
By understanding your specific requirements for volume and frequency, we can tailor a solution that fits your supply chain perfectly.
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