Lyophilised vials
Enhancing Lyophilised Vials Integrity
Ensuring the integrity of lyophilised vials is crucial in pharmaceutical manufacturing. Stancor Pharma specializes in providing robust contract manufacturing solutions to enhance product stability and safety.
The wear problem
Lyophilised vials commonly experience wear due to shock and thermal stress during the filling and sealing processes. The wear mechanism can lead to cracking and integrity loss, primarily affecting the vial closures and seals which are critical for product sterility.
Recommended plate by component
| Component | Grade | Thickness | Why |
|---|---|---|---|
| Vial Closures | oncology injectables | 1-2 mm | Increased resistance to impact and thermal stress. |
| Sealing Rings | biosimilar development programmes | 2-3 mm | Enhanced sealing performance and reduced breakage risk. |
| Filling Needles | general injectables | 0.5-1 mm | Longer operational life due to improved wear resistance. |
| Plungers | oral dosage forms | 3-5 mm | Minimized wear and prolonged performance under cyclic stress. |
| Transfer Bottles | contrast media | 4-6 mm | Enhanced durability to withstand high-pressure applications. |
Selecting the right plate
Material compatibility
Select materials that have low reactivity with pharmaceutical compounds.
Regulatory compliance
Ensure all components meet the necessary GMP standards for pharmaceuticals.
Production scalability
Consider the batch size capabilities to match your volume requirements.
Technology transfer processes
Evaluate the transfer methodologies to ensure plate integration into your workflow.
Questions engineers ask
What standards do you adhere to?
We follow stringent GMP protocols to ensure product quality and safety. Our facilities are designed to meet various regulatory requirements.
How do you ensure product stability?
We utilize advanced analytical methods and stability chambers to monitor and maintain product integrity. This minimizes the risk of wear and degradation.
What is the lead time for production?
Lead times vary based on specific project requirements, but we aim to provide efficient turnaround while maintaining quality standards.
Can you handle bulk orders?
Yes, we are equipped to handle both small and large scale manufacturing, adjusting our processes to fit client needs.
Get a quotation for lyophilised vials
Send your specification and requirement and we respond with options and a full release data pack.
Request a quotation