Manufacturing

Bio-Techne (formerly Bionostics) specializes in flexible manufacturing in our modern, FDA registered cGMP facility certified to ISO 9001:2008 and ISO 13845:2003. Capabilities range from high volume automated filling to labeling and packaging:

Formulation batch sizes from 15ml to 1000L
Ampoule filling from 1ml to 5ml
Pasteurization, autoclaving, irradiation
Bottle and vial filling in a multitude of configurations
Single use packaging in a variety of configurations
Vision systems and weight checks

Engineering

The Bio-Techne (formerly Bionostics) engineering staff works with our customers to identify and understand their unique packaging requirements. From development to production, we ensure delivery of the highest quality packaging solutions with optimal manufacturability. Engineering services include:

Validation services

New component configurations
Installation, Operation (IQ/OQ) and Performance Qualifications for equipment and machines
Manufacturing processes
Ship studies

Detailed documentation

Formulation processes
Filling operations
Labeling and packaging assemblies
Design and customization of packaging configuration

Custom design

Primary container specific for ease of use
Material evaluation and selection
Packaging specific for end user application