Contract Manufacturing and Packaging ServicesSource: STERIS Corporation
Biotest Laboratories manufactures a variety of products through numerous semi-automated and manual manufacturing lines.
Our contract services include assembly, passivation, cleaning, bonding, and aseptic bending and filling. Cleaning and passivation lines are batch processes that may include the following rinses: alcohol, detergents, USP purified water, WFIr and/or specified acid concentrations.
Packaging, labeling, bar coding, boxing and palletizing operations are also established for many of our manufacturing lines. Our contract packaging services include pouches and trays for radiation, ethylene oxide and steam sterilized products. Steam sterilization may also be performed onsite at Biotest Laboratories.
ISO 5 (class 100) areas are also available for stricter particulate sensitive operations involving manufacturing, assembly, cleaning and passivation for implantable device and drug delivery system lines.
Product types manufactured include:
- Catheter products
- Composite drug delivery systems
- Implantable microchips
- Liquid filling
- Ocular implants
- Pharmaceutical manufacturing aids
- Stainless steel and titanium implants
- Surgical supplies
- Tubing sets (infusion & perfusion)
Process validation is recommended for routine contract manufacturing. In particular, chemical bonding, packaging, cleaning, passivation, sterilization processes and laboratory test methods should be validated. Biotest Laboratories provides inspection tests on materials and products at various stages during the manufacturing process. These tests are conducted on incoming materials, components, validation samples, in process and product for final release.
These tests are conducted on incoming materials, components, validation samples, in-process and product for final release.
A dimensional, micron level non-contact measurement system with x, y and z axes, as well as length, is available. Visual inspections aided by various microscopic magnification levels and photographic methods are also available.
Testing services provided:
- Seal test integrity (pouches and tray)
- Peel test
- Dye test
- Burst test
- Visual intact
- Visual adhesive transfer
Product Inspection Services Provided
- Metrology system non-contact measurement to micron level
- Deltronic dimensional measurement
- Microscopic inspections
- Drop gauge