Industries · DMX-IND-02
Pharmaceutical grade materials with documentation for change control
Materials for validated production and packaging environments, where a grade change is a documented event. Selection is driven by biocompatibility class, extractables and leachables profile, sterilisation method and the retention of lot-level records your quality system requires.
- Standards
- USP VI · ISO 10993
- Sterilisation
- Steam · EtO · gamma
- Supply chain
- ISO 13485:2016
- Record retention
- 7 years
Supply chain standards
The standards we require from our supply chain
Biocompatibility and quality-system conformity are held by the certified manufacturing partners producing the stock. We require current certification and grade-level test data on file before a material is offered into a validated environment.
Certifications listed are held by certified manufacturing partners in our supply chain. Damrix is a distributor and does not hold manufacturing certification.
Sector requirements
What a validated environment demands of a material
A material entering a validated process carries an administrative burden alongside the technical one. Both are addressed before the first order.
REQ 01
Biocompatibility class
USP Class VI or ISO 10993 test data must exist for the specific grade and be traceable to the resin lot, not asserted at the family level.
REQ 02
Sterilisation survival
Repeat autoclave, EtO or gamma exposure degrades some polymers. PEEK, PEI and PPSU are specified where cycle counts run into the hundreds.
REQ 03
Extractables profile
Low-extractables grades are required for fluid-path and product-contact service. Additive and pigment packages are disclosed on request.
REQ 04
Change control
Grade substitutions and upstream source changes are notified in writing so your validation status is never altered without a record.
Qualifying materials
Grades applied in this sector
Grades below are carried with biocompatibility or fluid-path documentation available on selected variants. Medical and high-purity grades are identified by grade code, not by family.
- PEEKDMX-HP-101
Semi-crystalline high-performance thermoplastic for sustained load at elevated temperature, steam exposure and repeat sterilisation cycles.
FDAUSP CLASS VIEU 10/2011 - PEI / ULTEM-typeDMX-HP-104
Amorphous, transparent-amber high-temperature material with high dielectric strength and hydrolytic stability.
FDAUSP CLASS VINSF 61 - PSU / PPSUDMX-HP-107
Transparent-amber sulphone polymers that withstand repeated steam sterilisation and aggressive cleaning chemistry.
FDAUSP CLASS VINSF 61 - PTFEDMX-HP-105
Lowest coefficient of friction of any solid material, near-universal chemical inertness and the widest service temperature window we carry.
FDAUSP CLASS VI3-A DAIRY - PVDFDMX-HP-106
Fluoropolymer with high purity and resistance to halogens and strong acids; standard for ultrapure fluid handling.
FDANSF 61USP CLASS VI (select grades) - POM-C / POM-HDMX-EN-203
The general-purpose precision machining material — tight tolerance hold, low moisture uptake and consistent stiffness.
FDANSF 513-A DAIRY - PP-H / PP-CDMX-EN-206
Acid and base resistant, weldable and low cost; standard for fabricated chemical containment.
FDANSF 51USP CLASS VI (select grades) - UHMW-PEDMX-EN-201
Highest abrasion resistance of any thermoplastic with very low friction; the default wear material for food conveying and bulk material handling.
FDANSF 513-A DAIRY - PPSDMX-HP-103
Dimensionally stable, chemically inert semi-crystalline material with essentially no known solvents below 200 °C.
FDANSF 51 (select grades)UL 94 V-0
Documentation
What ships with the material
Every document is issued against the lot shipped so it can be filed directly against a validated process without a secondary request cycle.
Next step
Review a validated-environment requirement
Send the application, sterilisation method, biocompatibility class required and the documentation your quality system needs on file. We confirm qualifying grades and data availability.