Sterile manufacturing
We provide contract manufacturing services to Life Sciences companies throughout the world :
Pharma & Healthcare
Microbiology
Cosmetics
Veterinary
Wish to outsource the end-to-end manufacturing of your sterile liquid products with time and cost effectiveness ?
Pharmaceutical excipients
Culture media
Cosmetic solutions
Medical devices & in vitro diagnostic
An unrivaled technical expertise and industrial infrastructures for the manufacturing and packaging of your sterile liquid products
Sourcing and
Control
- Supplied by the customer or selected by Indicia under supplier management process.
- Full raw material QC process carried out by Indicia in accordance with customer’s requirements.
- Formulation in accordance with our customer manufacturing instructions.
- Mixing in autoprocessor or tanks (heated or non-heated)fitted with disposable liner.
- In process QC management.
- Aseptic filling of liquid reagents is carried out on disposable filling lines, under class A laminar flow in a class B environment, by two experienced operators holding the required authorisations.
- The production environment is re-qualified in accordance with the provisions of the NF EN ISO 14644 standard.
Packaging
- Verification of product quality by visual inspection.
- Labelling according to customer specifications in terms of label format, logo, bar code, flash code, etc.
- Secondary packaging in boxes then on pallets as required.
Control
- QC on finished products conducted by in-house laboratory, according to European Pharmacopoeia and/or ISO reference standards.
- Custom controls on request.
- Physical, Chemical, Sterility and Performance testing
An experienced team committed to support the development, transfert and manufacturing of your product
Indicia assists its customers in all steps for a successful industrial application:
- Sourcing of raw materials
- Pilot batches
- Scale-up and industrialisation
- Implementation of regulatory Quality Controls
- Documentation system and recording
- Risk analysis
- Stability studies
We put Quality at the core of everything we do
ISO Certifications
NF EN ISO 9001, NF EN ISO 13485.
Good Manufacturing Practices
relating to medicinal products for human use and active substances used as raw materials in medicinal products.
In-house Quality Control capabilities
European Pharmacopoeia, ISO 21149 (cosmetic)
Experienced Staff
Indicia’s technicians hold the required authorisations which are regularly renewed by conducting media fill tests.
Full Traceability
Extensive documentation system (procedures, records, instructions, etc.) recorded within individual batch file
« Since 2005, our facilities have undergone more than 100 regulatory and client inspections »
