Tubes, gaskets, valves and LSR parts for bioreactors, packaging lines, GMP autoclaves, freeze-dryers and CIP/SIP cleaning processes. Platinum catalysis with USP Class VI and ISO 10993 testing in ISO 8 cleanroom under Good Manufacturing Practice.
In aseptic pharmaceutical and biotech processes, silicone is in direct contact with active substance, cell culture medium, biological product or water for injection. The GMP framework defines the manufacturing system; USP Class VI and ISO 10993 set the elastomer testing; the European Pharmacopoeia sets the admitted raw materials and additives. Every batch travels under a documentary file archived per MDR 2017/745, accessible for health authority and regulator audits.
A management system governing the production of raw materials, equipment and components for active substance and medical product. Every operation is documented (what, who, when, with what result). EU GMP guide Annex 1 applies to aseptic production. Progress group facilities operate under this documentation aligned with ISO 13485.
Components in contact with the product are cleaned without disassembly (Cleaning in Place) and sterilised with saturated steam on the line itself (Sterilization in Place). The silicone must withstand alkaline agents (NaOH 2-5 %), acids (HNO₃ 0.5-2 %) and steam at 121-134 °C over thousands of cycles without degrading. Series S14 of the Progress catalogue is optimised for this requirement.
Compatibility with autoclave (saturated steam 121-134 °C, ISO 17665), ethylene oxide (EtO, ISO 11135) and 25-40 kGy gamma radiation (ISO 11137). Validation of mechanical and dimensional properties after repeated cycles within the customer's qualification plan.
Unique batch number assigned at the banbury and maintained across the whole chain. Each shipment leaves with a certificate of conformity, compound data sheet, raw material CoA, dimensional control plan ISO 3302-1 E1 / M2, and references to applicable USP Class VI / ISO 10993 testing. Archive per MDR 2017/745 and ICH.
Apt (France, 550 m² ISO 8) operates extrusion and moulding of compounds for pharmaceutical processes under ISO 13485 with a documented inspection plan. Top Tech Silicones (Italy, 1,500 m²) concentrates aseptic LSR injection with six dedicated presses — the largest pharmaceutical LSR capacity in the group. Both plants operate under the same Progress management system and share an equipment and operator qualification plan.
European and US regulatory framework for aseptic production of medicines, biotechnology and related processes. Specific coverage of each series is verified case by case according to colorants, fillers and final-customer validation.
| Standard | Scope of application |
|---|---|
| EU GMP (Annex 1) | Good Manufacturing Practice for sterile medicinal products · process system |
| ISO 13485 | Quality management system for medical devices · applicable to pharmaceutical components |
| ISO 9001 | General quality management system |
| USP Class VI | US Pharmacopeia · biological compatibility test on elastomers |
| USP <87> / <88> | In vitro and in vivo biological reactivity · complementary tests to USP VI |
| ISO 10993-1 / -5 / -10 | Biological evaluation · cytotoxicity, sensitisation, irritation |
| European Pharmacopoeia | Raw materials and additives accepted for pharmaceutical components |
| ISO 14644-1 | Cleanroom classes · ISO 8 room for aseptic production |
| ISO 17665 / 11135 / 11137 | Validation of sterilisation by steam, EtO and gamma radiation |
| 21 CFR 177.2600 | FDA · rubber suitable for food contact and pharmaceutical processes |
| ISO 14971 | Risk management applied to medical devices and components |
| REACH (CE 1907/2006) | Registration, evaluation and restriction of chemical substances |
| RoHS (2015/863) | Restriction of hazardous substances in EEE associated with production |
Four series of the Progress catalogue cover the typical sector scenarios: contact with active substance (S17), peristaltic transfer pumps (S30), in-line CIP/SIP cleaning with repeated autoclave (S14) and visual process observation (S12).
NuSil-based platinum-cured VMQ · Shore A 25-80 · range −60 / +200 °C · full USP <87>/<88> and ISO 10993-1/-5/-10 testing. Qualified short-term implantable (
Platinum-cured VMQ · Shore A 50-65 · range −60 / +180 °C (+215 °C transient). Resistance to repeated deformation (controlled compression set) for peristaltic pumps transferring medium, aseptic filling and active substance dosing. FDA + USP VI + ISO 10993.
Peroxide-cured VMQ · Shore A 60-70 · range −60 / +200 °C. Optimised for resistance to saturated steam, coolant and oils in repeated CIP/SIP cleaning cycles. FDA + BfR IX/XV. For autoclave, freeze-dryer and GMP equipment gaskets with in-line sterilisation.
Platinum-cured VMQ · Shore A 20-90 (widest range of the platinum catalogue) · range −60 / +200 °C (+300 °C transient). Translucent version for visual detection of obstruction in process lines. FDA + CE 1935 + ISO 10993 + USP VI where the colorant allows.
The base polymer arrives with the supplier's CoA and declaration of compliance to USP Class VI, USP <87>/<88>, ISO 10993 and European Pharmacopoeia. Each banbury assigns a unique batch number maintained from formulation to primary packaging — mixing, calendering, extrusion or injection, post-cure in sealed stainless-steel oven, dimensional control and packaging.
Each shipment leaves with a GMP certificate of conformity, compound mechanical data sheet, dimensional control plan ISO 3302-1 E1 (extrusion) or M2 (moulding), sterilisation cycle history if applicable, and reference to applicable USP / ISO 10993 testing. The file is archived per MDR 2017/745, ICH Q7/Q9/Q10 and ISO 14971, accessible for audits by notified bodies and health authorities.
Reference catalogue of the families most requested in aseptic pharmaceutical and biotech production: bioreactors and cell culture tanks, packaging lines and vial filling, single-use systems, GMP sterilisation equipment (autoclaves, freeze-dryers) and ISO 8 cleanroom doors.
| Product | Typical application in the sector | Data sheet |
|---|---|---|
| Pharmaceutical LSR injection | Aseptic closures, sterile connectors, process valves, single-use systems | View details |
| Peristaltic hoses | Active ingredient transfer, vial filling, aseptic mixing | View details |
| Reinforced hoses | Pressurised process lines, transfer of media and water for injection | View details |
| Vulcanised seals | GMP autoclave, freeze dryer, process steriliser, flanged connections | View details |
| Platinum-cured O-rings | Sealing of cell culture tanks, bioreactors, fermenters | View details |
| Inflatable seals | ISO 8 GMP cleanroom doors with active expansion on closing | View details |
| Flat gaskets | Sealing of aseptic process equipment, reactor lids, packaging lines | View details |
| 2K bi-material overmoulding | Plastic-silicone components for single-use valves and connectors | View details |
Send us the process context (filling, mixing, biotech, single-use), the CIP/SIP cleaning requirements, the sterilisation method (autoclave, EtO, gamma), dimensions and estimated series. We confirm the applicable series (S17, S30, S14 or S12), available USP / ISO 10993 testing, assigned group plant and sample lead time tested. No purchase commitment.
