Cleanroom Injection Molding

SteriPack cleanroom injection molding 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 molding 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 molding 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 (mold flow analysis, tolerance analysis, feasibility studies)
  •  Prototype molds for proof of concept/design
  •  Single cavity and multi-cavity mold design and validation with mold life assessment
  •  Hot-runner and cold-runner mold design and build
  •  Global standardization of World Class Injection Molding machines
  •  Molding validation IQ, DOE, FAI, OQ, PQ, Gauge R&R
  •  State of art validation measurements using Computer Measurement Machine (CMM) and CT scan
  •  Tool maintenance

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 molding 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 molding
  •  Scientific molding approach (RJG)
  •  Masterbatch additive processing
  •  UV – ultraviolet light resistance
  •  Flame retardants
  •  Anti-fouling
  •  Anti-static
  •  Lubrication
  •  Anti-slip
  •  Corrosion inhibitors for metals packaged in plastic
  •  Anti-microbials
  •  Anti-oxidants
  •  Extrusion aids
  •  Phosphorescence
  •  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.

Cleanroom injection molding