Trustworthy partner in contract manufacturing
We offer contract manufacturing services for manufacturers of Medical Devices, animal health, cosmetics and cleaning products as well as for product development needs. We act as Medical Device OEM and OBL manufacturer.
Our quality management system complies with the most stringent requirements in the industry. Our operations are certified according to the international ISO 13485 standard. We also fulfill requirements of Health Canada and Brazilian GMP for Medical Devices inspected by ANVISA. We comply with ISO 17025 standard and GLP practices in general.
High quality cleanrooms for aseptic filling
In our ISO 5 class clean room, we manufacture Sterile A products by aseptic filling with three automated bottling lines. Bottle sizes vary from 10 ml to 360 ml. Various other products including cosmetics, personal care, cleaning and animal health products are manufactured in the ISO 8 class clean room. Available bottling sizes are 50 – 600 ml up to 5 L canisters. For R&D purposes we can manufacture solutions from just a few milliliters to full scale manufacturing batches over 5000 liters.
Comprehensive design and quality management services
We provide comprehensive product development and design services for Medical Devices and wellness products, especially in liquid form. We can assist you with ideas for a final product or, offer you separate parts of a product’s R&D or its manufacturing according to ISO standards and MEDDEV regulations. These can be, for instance, desing, shelf-life investigations, aseptic manufacturing acc. to ISO 13408 or GMP regulations, preparing of technical files, risk analyses, clinical evaluations (CER), drawing of texts for sales package, QA/QC determination during production until final release of batches.
We offer also comprehensive laboratory services. You will find more information here.
Are you interested in our contract manufacturing services? Please contact:
Riikka Järvinen
Managing Director
Chemistry Division, Director
Tel. +358 50 5585375
riikka.jarvinen (at) piiloset.fi
