We offer clients a manufacturing service for clinical trial samples and medical device components using electrospinning and associated processes. We have engineering capabilities to combine electrospun membranes with other materials or device components.
We operate in ISO Class VII clean rooms to stringent quality-controlled operating procedures governed by ISO 13485:2016 certification. We provide supporting documentation including Certificates of Conformance for all batches.
Our capabilities include:
- Cleanroom modules that permit segregation of workflows
- Electrospinning machines from three manufacturers
- Vacuum drying and removal of residual solvent
- Thermal annealing
- Solution dispensing
- Die-cutting and laser machining
- Sonic welding
- Packaging including a blister pack line
We provide further services through our network of approved suppliers:
- Sterilisation by gamma-irradiation, e-beam or ethylene oxide treatment
- Bioburden and sterility studies
- Plasma treatment
We supply the first electrospun material component to be included in an FDA-approved medical device and sold in the USA.
Quality is checked visually and by SEM within the clean room. All materials are supplied to customers with Certificates of Analysis/ Conformance.