Medical

Engineered to Protect Your Product and Accelerate Regulatory Approval

As a sterile pouch manufacturer and pharmaceutical packaging supplier serving Class I–III medical device makers, contract manufacturers, and pharma brands in 40+ countries, we understand packaging is an integral part of the regulated product. Our medical-grade flexible packaging solutions are purposefully designed to solve the toughest barrier, sterilization, and audit challenges, ensuring a secure and efficient path to market.

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Medical & Pharmaceutical Packaging

Sterile barrier. Fortress protection. Audit-proof compliance — engineered for pharmaceuticals that demand zero risk from factory to patient.

Sterility Assurance

Our Tyvek and medical paper pouches strictly comply with ISO 11607-1, validating a Sterility Assurance Level (SAL) of 10⁻⁶ from sterilization to the point of use.

Moisture & Light Sensitivity

Our aluminum foil pharma pouches deliver an ultra-high barrier (WVTR < 0.01 g/m²/day) and UV-blocking opaque films to protect active pharmaceutical ingredients (APIs).

Regulatory Compliance & Audit Risks

Every batch is manufactured under GMP controls with full material traceability, supporting your FDA 21 CFR 820 and EU MDR submission timelines.

Medical & Pharmaceutical Pouch Formats We Manufacture

Every medical product — from a sterile scalpel to a moisture-sensitive oral tablet — has an optimal pouch format defined by its sterilization method, barrier requirement, and regulatory classification. As an OEM medical packaging manufacturer with in-house multi-layer lamination and cleanroom-controlled converting, we are fully equipped to fulfill your custom flexible packaging requirements across all dimensions and specifications. Below is our complete capability matrix.

Recommended Pouch	Optimal Application Areas	Material Structures	Key Technical Spec
Sterile Barrier Pouch	Surgical instruments, implants, catheters, syringes	Tyvek / Medical Paper + Film Laminate	Sterilization: EO, Gamma, Steam compatible Integrity: Dye-penetration tested (ASTM F1929)
Aluminum Foil Pouch	Oral tablets, capsules, effervescent powders, APIs	PET / AL / PE, Paper / AL / PE	WVTR: < 0.01 g/m²/day OTR: < 0.5 cc/m²/day (High barrier)
Unit-Dose Stick Pack	Powder drugs, granules, OTC sachets, nutraceuticals	Multi-layer Foil Laminate	Dosing: 1–15g precision dosing Feature: Laser tear notch, Child-resistant option
Medical Device Bag	Surgical kits, wound care dressings, diagnostic devices	Sealable PE/PA Composite	Thickness: Puncture-resistant 4–6 mil Format: Large format up to 800mm
Liquid Spout Pouch	Oral liquids, ointments, gels, veterinary liquids	High-barrier AL Laminate	Cap: Tamper-evident closure Safety: 100% Leak-proof & drop-tested

Sterile-Safe Manufacturing & Material Capabilities

Zero cross-contamination. Zero sterilization risk. Zero labeling steps — engineered for medical and pharma products that demand absolute compliance from fab to patient.

Cleanroom Controlled Converting

Physically separated converting zone with HEPA-filtered air. Food and medical lines never run concurrently to prevent cross-contamination.

Sterilization Validation

Materials pre-qualified for EO (ISO 11135), Gamma (ISO 11137), and Steam (ISO 17665) with aeration-safe, non-fading buried inks.

Compliance Qualifications

ISO 9001 certified quality system; materials qualified for FDA 21 CFR 820 and EU MDR compliance support; partner audits supported on request.

Serialization Ready Primary Packaging

Direct-printed unique IDs and barcodes integrated into primary packaging, supporting EU FMD and US DSCSA traceability requirements without additional labeling steps.

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Medical & Pharma FAQs

Clear answers about medical & pharmaceutical packaging, customization, pricing, shipping and after-sales support.

Q1. Can you provide the necessary documentation for our regulatory audits?

Yes. Every batch ships with full batch records, COAs, and sterilization validation summaries to directly support your QA team’s compliance files.

Q2. Do you support small runs for clinical trials?

Yes. We support clinical trial runs with flexible order quantities evaluated per project, complete with serialization and unique random ID printing.

Q3. How do you ensure the pouch seals won't fail during transit or sterilization?

We conduct 100% visual inspection and sampling dye-penetration tests (ASTM F1929). Our peel strength is strictly documented between 0.5–4.0 N/15mm (ASTM F88).

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