Indicia Production
Sterile reagent production
Indicia Biotechnology provides custom-made liquid reagents and sterile solutions for IVD, pharmaceutical and cosmetic companies.
Based closed to Lyon (69, France), Indicia Biotechnology’s production site is 15 years experienced in tailor-made solutions.
These facilities are adapted for production of your reagents, aseptic solutions in small and medium scales (cleanrooms, biosafety level 2 laboratory, hoods, …).
Indicia Biotechnology’s production site complies with ISO9001:2000 and EN ISO13485:2004 international quality standards. We also meet GMP guidelines if required.
Our quality system and our knowledge in regulatory affairs are under constant review in order to improve and meet customer satisfaction.
Our offer includes
1- Formulation
Following your specifications, Indicia Biotechnology realizes simple or more complex and varied formulations in industrial tanks.
2- Aseptic or sterile filling
Batches from 1 to 1,000 liters.
Repartition capabilities around 10,000 units, depending on the type of packaging.
3- Quality control
Control of raw materials in compliance with the European Pharmacopoeia (if needed) and release tests on finished products.
Current controls: pH measurement, sterility, conducitivity, titration, osmolarity, environmental control, …and more if required.
4- Primary packaging
Tubes, bottles and bags…
5- Labelling
According to customers specifications :
- product name,
- customer reference,
- internal batch number and/or customer batch number,
- peremption date,
- storage conditions, risks labels (for example : toxic, flammable, corrosive, …)
6- Secondary and external packaging
Final packaging on filmed pallets
7- Distribution to the customer’s site
Choice of the carrier, controlled temperature possible, deliveries on specific days and hours.
Categories of products
- Pharmaceutical raw materials (buffers, conservatives,…), sterile API (active pharmaceutical ingredient)
- In Vitro Diagnostic reagents
- Hygiene and disinfection products (soda, bleach, …)
- Media fill for process simulation (aseptic filling test…)
Choosing Indicia Biotechnology for your sterile/aseptic production
- Reduced costs
- Immediate access to cutting-edge technical expertise and experience adapted to health industry
- Immediate availability of important and flexible production capacities
- A reduction of your production charge for a reallocation of your resources