SteriPack cleanroom injection moulding offer high precision medical device components using a host of materials including medical grade elastomers and most thermoplastic grades commonly used in medical device manufacturing. We offer Class 7 & 8 cleanroom plastic injection moulding of complex components for the life science markets of medical device, drug delivery and pharmaceutical products.
We strive to support our Customers from product development and R&D services with design for manufacture (DFM) of Customer’s plastic components to post-project implementation.
SteriPack adheres to stringent cGMP and ISO cleanroom injection moulding and operating procedures to ensure the highest quality in medical device components.
SteriPack supports in following processes:
- Material selection (resin & masterbatch, additives)
- Re-engineering and cost reduction improvement
- Design review & collaboration for each customer’s component
- DFM (mould flow analysis, tolerance analysis, feasibility studies)
- Prototype moulds for proof of concept/design
- Single cavity and multi-cavity mould design and validation with mould life assesement
- Hot-runner and cold-runner mould design and build
- Global standardisation of World Class Injection Moulding machines
- Moulding validation IQ, DOE, FAI, OQ, PQ, Gauge R&R
- State of art validation measurements using Computer Measurement Machine (CMM) and CT scan
- Tool maintanace
SteriPack’s Project Engineering Team provides expertise, knowledge and technical support to our customers within the Medical Device Manufacturing sectors.
As a certified ISO-13485 and FDA registered contract manufacturer we offer In-house Injection moulding of medical device components to the highest of standards of precision, cleanliness and tolerances as well as controlled documentation and traceability.
Cleanroom injection moulding:
- Dedicated ISO Class 7 & 8 cleanroom injection moulding
- Scientific moulding approach (RJG)
- Masterbatch additive processing
- UV – ultraviolet light resistance
- Flame retardants
- Corrosion inhibitors for metals packaged in plastic
- Extrusion aids
- Inline (work cell) tolerance validation – Computer Measurement Machine (CMM) and CT scan
SteriPack resin processing capabilities:
- ABS Acrylonitrile Butadiene Styrene
- HDPE High Density Polyethylene
- LDPE Low Density Polyethylene
- COC Cyclic Olefin Copolymers
- PA Polyamide (Nylon)
- PC Polycarbonate
- PE Polyethylene
- PSU PolySulfone
- PMMA Polymethylmethacrylate (aka acrylic, plexiglass)
- POM Polyoxymethylene (Acetal)
- PP Polypropylene
- PS Polystyrene
- TPE, TPU, TPV Thermoplastic Elastomer
- TPO Thermoplastic Polyolefin
- PEEK Poly Ether Ether Ketone
Typical application areas:
single use plastic components and devices to be further processed in assembly and packaging in-line processing under one roof.