Manufacturing of sterile drapes, drapes and pharmaceutical liners from extruded films and injection-molded parts
PEMAX Kunststoff GmbH
Stuttgart (Curiestraße 2)New on Amplifa
About PEMAX Kunststoff
PEMAX Kunststoff GmbH, headquartered in Stuttgart, manufactures plastic products for medical technology and the pharmaceutical industry, including sterile drapes for surgical instruments, microscope and equipment covers (drapes) as well as liners for the pharmaceutical industry. To ensure product quality, all components are manufactured in-house: from film extrusion and blow extrusion through thermoforming to injection molding. In addition, the company has its own toolmaking shop for injection molding and blow molding tools. The assembly of medical devices takes place in the cleanroom, partly using self-developed production automation systems and partly as manual assembly for very small series. The processing portfolio includes cutting and punching, heat contact and ultrasonic welding, sewing, printing, bonding and laser cutting. Base materials used include polyethylene, polypropylene, polyamide, ABS as well as rubber and latex substitute materials, optionally with FDA certification, DMF registration or approval under the European and US Pharmacopeia. Sterile packaging, labeling and sterilization by a qualified irradiation service provider round out the offering.
- Site
- Stuttgart
- Processes
- Film extrusion, Blow extrusion (blow molding), Thermoforming, Injection molding, Toolmaking (injection molding and blow molding tools), Cleanroom assembly and inspection, Cutting and punching, Heat contact welding
- Materials
- Polyethylene, Polypropylene, Polyamide, ABS, Rubber and latex substitute materials, Rubber (ocular ring)
- Certificates
- DIN EN ISO 13485
- Industries
- Medical technology, Pharmaceutical industry
- 01
Toolmaking
- 02
Film extrusion
- 03
Blow extrusion
- 04
Thermoforming
- 05
Injection molding
- 06
Assembly (cutting, punching, welding, sewing, printing, bonding)
- 07
Cleanroom assembly and inspection
- 08
Sterile packaging and labeling
- 09
Sterilization by irradiation service provider
Materials and Processes
Polyethylene
Base material for films, sterile drapes and packaging products with FDA certification and DMF registration.
Polypropylene
Used for extruded films, thermoformed parts and injection-molded components.
Polyamide
Used for requirements demanding higher mechanical and thermal strength.
ABS
Base material for injection-molded and thermoformed parts in the medical technology environment.
Rubber and latex substitute materials
Material base, among other things, for ocular rings and elastic components.
Locations
Stuttgart
DEHeadquarters with film extrusion, blow extrusion, thermoforming, injection molding, toolmaking and cleanroom assembly
- Materials
- Polyethylene, polypropylene, polyamide, ABS, rubber and latex substitute materials
- Film extrusion
- Blow extrusion
- Thermoforming systems
- Injection molding machines
- Cleanroom
- Self-developed production automation systems
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Film extrusionPlastics | – | – | – | – | Polyethylene, Polypropylene, Polyamide, ABS, Rubber and latex substitute materials |
| Blow extrusion (blow molding)Plastics | – | – | – | – | Polyethylene, Polypropylene, Polyamide, ABS, Rubber and latex substitute materials |
| ThermoformingPlastics | – | – | – | – | Polyethylene, Polypropylene, Polyamide, ABS, Rubber and latex substitute materials |
| Injection moldingPlastics | – | – | – | – | Polyethylene, Polypropylene, Polyamide, ABS, Rubber and latex substitute materials |
| Toolmaking (injection molding and blow molding tools)Engineering | – | – | – | – | – |
| Cleanroom assembly and inspectionAssembly | – | – | – | – | – |
| Cutting and punchingPlastics | – | – | – | – | – |
| Heat contact weldingJoining | – | – | – | – | Plastics |
| Ultrasonic weldingJoining | – | – | – | – | Plastics |
| SewingJoining | – | – | – | – | – |
| PrintingSurface | – | – | – | – | – |
| BondingJoining | – | – | – | – | – |
| Laser cuttingPlastics | – | – | – | – | – |
| Sterile packaging, shipping packaging and labelingAssembly | – | – | – | – | – |
Additional services
Reference customers
Quality
The products are assembled under controlled conditions in the cleanroom and continuously inspected according to work instructions and control plans. The quality management system is certified to DIN EN ISO 13485.
| Evidence | Stuttgart |
|---|---|
| DIN EN ISO 13485 |