Teclen manufactures sterile barriers and container systems for aseptic lyophilization in the pharmaceutical industry.
Teclen GmbH
OberpframmernNew on Amplifa
About Teclen
Teclen GmbH was founded in January 2017 by Rolf Lenhardt and is an owner-managed company based in Oberpframmern near Munich. Teclen develops, produces and sells the Lyoprotect® product line for sterile lyophilization (freeze-drying) in the pharmaceutical industry: stainless steel trays and dishes, single-use trays, bags for vials, bulk and direct fill, as well as the ePTFE membrane on PP non-woven as a sterile barrier. The products prevent fly-out and cross-contamination during sublimation, while vapor can escape through the hydrophobic membrane. Custom solutions are also offered for very small production volumes, tailored to the footprint of the respective freeze-dryer. Manufacturing takes place in-house or with experienced partners within Germany; all products are autoclavable at 121°C for 20 minutes and can additionally be sterilized with EtO and VHP. Reference customers include Numaferm, Heraeus Pharmaceutical Ingredients, ProJect Pharmaceutics, Lactosan and Cilian.
- Site
- Oberpframmern
- Processes
- Manufacture of stainless steel trays (Lyoprotect® Stainless Steel Trays) with ePTFE membrane as, Laser welding of 45° corners on stainless steel trays, Manufacture of custom single-use products (bags, single-use trays, membranes) for aseptic, Seam strength and seam leak tests (bag integrity), Incoming inspection by FTIR spectrometry, Endotoxin test (LAL test) and microbial barrier tests, Autoclavability of products (121°C, 20 min); sterilization with EtO and VHP possible
- Materials
- Stainless steel AISI 316L, ePTFE membrane on PP non-woven, Polypropylene non-woven (PP non-woven), Laser welding, Sterilization / Autoclaving
- Certificates
- ISO 9001 (TÜV SÜD)
- Industries
- Pharmaceutical industry, Biotechnology, GMP production of lyophilizates
- 01
Design and custom engineering
- 02
Procurement of plastic and stainless steel input materials
- 03
Manufacturing in-house or with experienced partners in Germany
- 04
Laser welding of the 45° corners on stainless steel trays
- 05
Assembly with membrane, gasket, filler assembly and fixing frame
- 06
100% visual inspection, release tests and release with CoA
Materials & Processes
Stainless steel AISI 316L
High-quality stainless steel for reusable trays and dishes with polished surface and works inspection certificate 3.1.
ePTFE membrane on PP non-woven
Hydrophobic, vapor-permeable sterile barrier that prevents fly-out and cross-contamination.
Polypropylene non-woven (PP non-woven)
Support material of the membrane and base material for single-use products such as bags and single-use trays.
Laser welding
Laser-welded 45° corners on stainless steel trays enable residue-free cleaning.
Sterilization / Autoclaving
All products are autoclavable at 121°C for 20 minutes; sterilization with EtO and VHP is possible.
Locations
Oberpframmern
DEDevelopment, production, quality assurance and sales
- Part weight / size
- Stainless steel trays up to 400 × 700 × 53 mm (up to 6000
- Lot size
- also very small production volumes, custom
- Materials
- Stainless steel AISI 316L (1.4404), ePTFE on PP non-woven
- FTIR spectrometer (incoming inspection)
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of stainless steel trays (Lyoprotect® Stainless Steel Trays) with ePTFE membrane asJoining | polished surface | 700 mm × 400 mm × 53 mm | – | – | Stainless steel AISI 316L (1.4404), ePTFE, PP non-woven |
| Laser welding of 45° corners on stainless steel traysJoining | – | – | – | – | Stainless steel AISI 316L (1.4404) |
| Manufacture of custom single-use products (bags, single-use trays, membranes) for asepticPlastics | – | – | – | – | ePTFE, PP non-woven |
| Seam strength and seam leak tests (bag integrity)Testing | – | – | – | – | – |
| Incoming inspection by FTIR spectrometryTesting | – | – | – | – | – |
| Endotoxin test (LAL test) and microbial barrier testsTesting | – | – | – | – | – |
| Autoclavability of products (121°C, 20 min); sterilization with EtO and VHP possibleSurface | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| FTIR spectrometer | – | – | – | – | Oberpframmern |
Quality
All membranes and components are 100% visually inspected; the chemical composition of the plastic input materials is checked by FTIR spectrometry. Release tests include seam strength and seam leak tests; external laboratories perform Gelbo Flex abrasion tests, LAL endotoxin tests and microbial barrier tests.
| Evidence | Oberpframmern |
|---|---|
| ISO 9001 (TÜV SÜD) |
History
- 2017
Foundation of Teclen GmbH in January by Rolf Lenhardt in Oberpframmern (Bavaria).