In the pharmaceutical field
Stability, Reliability, Storage
Contract Manufacturing of raw materials (Active Pharmaceutical Ingredients-APIs).
Lyofal freeze-dries active substances of pharmaceutical use (bulk), APIs (Active Pharmaceutical Ingredients), in clean rooms which are according to ICHQ7A guidelines or cGMP.
We freeze dry your APIs in liquid phase according to your schedule of conditions defined in a client subcontractor contract, in order to yield a dry and a packaged safe from moisture lyophilisate.
Pharmacy is a field where lyophilization brings many advantages :
- Conservation of fragile substances in aqueous medium,
- Obtaining a chemical and microbial stability of certain products,
- Chemical Stability,
- Facilitated Dosage,
- Solvent Extraction,
- Facilitation of solubility,
- Medical Devices.
In this APIs zone, several freeze-driers can treat in an industrial scale batches of a few kilos with several tons.
These freeze-driers, of last generations, are sterile under vapour. Some of them run with liquid nitrogen.
All our operations are subject to prior contractual agreements and are carried out in the strict compliance with the rules of confidentiality.