Lyophilisation enquiries
Lyophilisation is a freeze-drying process. An enquiry to GALVANTA COMPANY LIMITED in this area should identify the proposed formulation, presentation, process question and documentary requirements.
Formulation suitability
Identify the substance, question concerning the proposed process and formulation-specific evidence for suitability beyond an image of dried material.
Cycle information
Identify the data or documentation sought, distinguishing a proposed cycle, a development study and a validated production process.
Vial handling
Specify the container, transfer and handling questions relevant to the proposal.
Freeze-drying scope
Describe the proposed process and responsibilities, identifying separate evidence for manufacturing permission, process performance and product quality.
Stoppering and sealing
Identify the proposed closure system and the supporting evidence for closure integrity and compatibility beyond the pack description.
Laboratory assessment
Identify the defined study and reconstitution or other laboratory examination concerned.
Contact
Email [email protected] with your organisation, country and purpose. Do not send confidential formulations or physical materials without an agreed arrangement.
Prerequisites
The company holds no pharmaceutical manufacturing licence or GMP certificate. Any proposed work requires evidenced capability, applicable authorisations and a separate agreement. Freeze-drying equipment, qualified cycles and laboratory operations require separate evidence. This page states no installed line or container-handling capability. Laboratory questions do not constitute instructions for preparing or administering a medicine.