Industries We Serve
Application notes for the three regulated verticals where silicon-free packaging matters most — with the compliance documentation to match.
Protecting API integrity from fill to patient
Silicone migration can interact with active ingredients, coatings and biologics — and complicates regulatory filings. Our silicon-free structures remove that variable entirely.
- Cleanroom bags for API, excipients and tablet cores
- High-barrier bags for moisture- and oxygen-sensitive products
- USP <788> particulate and extractables documentation per lot
- EU 10/2011 and FDA 21 CFR migration support data
- Child-resistant and senior-friendly reclosable formats on request
Low-extractable film for yield-critical processes
Cell culture media, buffers and single-use components demand packaging that contributes nothing to the process. Silicon-free, amide-free films protect yield and simplify validation.
- Media and buffer containment with low-leachable profiles
- Compatibility with single-use system gamma irradiation
- Endotoxin-controlled converting on request
- Lot-level traceability from resin to packed bag
- Documentation packs for QA and validation teams
Sterile-barrier systems built for validation
Pouches and lidding films engineered for ISO 11607 sterile-barrier validation — with consistent peel, sterilization stability across EtO, gamma and e-beam, and particulate control.
- Peelable pouches with controlled, fiber-free opening
- AlOx lidding films with OTR ≤1 cc/m²/24h for sensitive devices
- EtO, gamma (25–50 kGy) and e-beam stable constructions
- Sterilization process indicators printed in-house
- Support for seal validation and accelerated aging protocols
Why procurement teams are switching now
The amide- and silicon-free bag market is projected to grow from US$2.6B (2025) to US$4.86B by 2034 at a 6.8% CAGR — driven by tightening food-contact and pharma regulations in the EU, US and China.
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Our applications engineers respond to every qualified enquiry within one business day.