Cleanroom injection molding is a process used for producing medical device and combination product components in wide range of materials, enabling us to precisely match customer specifications. Along with advanced additive manufacturing, it delivers a full spectrum of capabilities.
Partnering with an outsourced contract manufacturer gives you access to the most cutting-edge equipment, highly skilled engineers and advanced technology which in turn helps to decrease project implementation lead-times and costs, whilst also overcoming limited capacity constraints. With the life saving device components and the need to ensure a low level of bioburden, outsourcing injection molding and other value-added services under one roof is a key advantage.
SteriPack uses cleanroom injection molding for medical device, combination and pharmaceutical components using a host of materials including medical grade elastomers and most thermoplastic grades is compliant to a variety of healthcare and medical standards and approvals (FDA, USP Class VI and others). We focus on complex components in medium to low quantities with the capability to producing parts from 0,1 to 100 cm³ in Class 7 and 8 controlled cleanroom environments. SteriPack injection molding is a part of complete device manufacturing process along with value-added services such as welding, printing, assembling, packaging and sterilization.
Value added services:
- Concept design
- Design development
- Design review (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
- Tool maintenance
- Injection molding validation
- Additive manufacturing / 3D printing
- Cleanroom injection molding
- Cleanroom contract manufacturing services
- Grey zone contract packaging services
System and technologies used:
- Scientific molding RJG – machine independent process that provides certain basic parameters to optimize molding process
- eDart – process monitoring and control system for plastic injection molding applications
- CT and X-ray scanning – A versatile high resolution system for 2D X-ray inspection and 3D computed tomography (micro CT and nano CT) and 3D metrology
- Global validation standards – IQ, DOE, FAI, OQ, PQ, Gauge R&R
- Arburg and Boy IMM – 200 tons with maximum volume of 350ccm
- Dryer with molecular sieves
Our expertise with resins and specialized medical grade plastics ensures that we can manufacture products to meet exact specifications. We are able to recommend resins of specific properties to meet customer requirements and ensure compatibility, as well as provide a tailored sterilization method.
- Commodity (PP, PS, PE)
- Engineered (ABS, PA, PC, POM, PSU, SBC, SMMA, PMMA)
- Exotics (COC, TPE, TPO, PEEK)
Technical data and additional equipment:
- Clamping force: 100 – 2 000 kN (200 ton)
- Injection volume: 0,1 – 350 cm³
- Max injection pressure: 2500 bar
- Distance between bars: 160 – 570 mm
- Minimum tool height: 100 mm
- Max plates distance: 900 mm
- Machine 6 zones and external 12 zones Hot Runner regulator
- Arburg and Wittmann external dryer
- Movacolor masterbatch dosing and mixing equipment
- Tool Temp and Wittmann thermoregulators
- Cooling water couplings standard
- 2 x hydraulic core pins
- 1 x valve gate controller
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.