PVC Film (Pharmaceutical Grade)

Pharmacopoeia & Regulatory Compliance

✅USP <661> | Chinese Pharmacopoeia | ✅GMP Compliance

1. Product Summary

• Product Name: Pharmaceutical Rigid PVC Sheet (Polyvinyl Chloride Solid Sheet)
• Primary Application: Forming web (base material) for blister packaging of solid oral dosage forms (tablets, capsules).
• Key Standards: Complies with USP General Chapter <661>, Chinese Pharmacopoeia, and GMP requirements for primary packaging materials.
• Core Properties: Excellent moisture vapor barrier, high transparency, reliable thermoformability, and good sealing compatibility with PTP aluminum foil.
• Standard Thickness: 200 μm, 250 μm (Customizable).
• Standard Formats: Rolls customized to your blister machine width and length requirements.
• Minimum Order Quantity (MOQ): 1 pilot/sample roll.

2. Why Partner with GTIG Guomian?

• 🏭Consistent Quality & Reliable Supply
  End-to-end quality control ensures batch-to-batch consistency. Stable production capacity safeguards your supply chain.
• 📑Full Compliance & Comprehensive Documentation
  Each batch includes a detailed Certificate of Analysis (COA). Full regulatory support (e.g., Compliance Statements, DMF/EDMF availability upon request) is provided.
• 🔬Technical Expertise & Application Support
  We provide technical data sheets and processing guidelines, with expert support for optimizing your blister packaging parameters.
• ✈️ Pharma-Dedicated Logistics
  We understand GDP requirements for pharmaceutical materials, ensuring secure, traceable global delivery with complete documentation.

3. Primary Applications

4. Product Overview: Foundational Barrier for Drug Stability

Our Pharmaceutical Rigid PVC Sheet is manufactured from controlled pharmaceutical-grade PVC resin. It offers a smooth, clear, and uniform surface, excellent forming characteristics, and reliable seal performance with standard PTP foils.

Addressing a Key Challenge: Moisture sensitivity is a critical concern for solid dosage forms. Our sheet provides a high moisture barrier (WVTR ≤ 1.5 g/m²/day), effectively protecting drug stability and shelf life against humidity, oxygen, and environmental contaminants.

5. Our Integrated Solution

a. Quality-Assured Supply Chain
We use certified raw materials and implement Statistical Process Control (SPC) to monitor critical parameters like thickness uniformity and barrier properties, ensuring reliable performance on high-speed blister lines.

b. Regulatory & Technical Partnership
Our documentation is designed to streamline your regulatory submissions and audits. We offer material selection guidance tailored to your specific drug product requirements.

c. Seamless Scalability
Flexible order quantities support your journey from R&D and pilot batches to full commercial production, backed by dependable lead times.

Typical Cooperation Workflow:
Inquiry → Sample Evaluation & Testing → Documentation Review → Commercial Order → Production & Delivery → Ongoing Support

6. Key Technical Specifications

Note: Specifications are customizable. Above values are typical; refer to batch-specific COA for certified data.

7. Storage & Handling Recommendations

Store in a cool, dry, clean environment below 25°C and <60% relative humidity. Protect from direct sunlight and contaminants. Keep in original packaging until use.

8. Frequently Asked Questions (FAQ)

• Q: Can we get samples for machine trials?
  A: Yes. We provide free sample rolls for machine compatibility testing and will supply all necessary technical documentation.
• Q: What regulatory documents do you provide?
  A: We supply a batch-specific COA, Material Safety Data Sheet (MSDS), and a Compliance Statement. Regulatory Master Files (DMF/EDMF) can be referenced under agreement.
• Q: Are custom thicknesses or colors available?
  A: Absolutely. We can customize thickness and offer opaque or tinted sheets (e.g., amber for light protection) based on your order volume.
• Q: What is the standard lead time?
  A: Lead time for standard commercial orders is 4-6 weeks after confirmation. Pilot batches can be expedited.

9. Related Products & Materials

We also supply a comprehensive range of pharmaceutical packaging materials:

• High-Barrier Composites: PVC/PVDC, PET/PVDC, PVC/EVOH, PET/EVOH sheets.
• Other Substrates: PET sheets, Aluminum Foil (PTP), Cold-Form Foil, and various laminates.

10. Your Trusted Partner in Pharma Packaging

GTIG Guomian is committed to being your quality-driven partner for critical pharmaceutical packaging solutions. We combine material science expertise with a customer-centric approach to support your projects from development through to commercial success.

[📧 CONTACT US Today for Technical Data, Free Samples, or a Quotation]

Document generation date: January 7, 2026

© 2026 GTIG Guomian

– Professional Pharmaceutical API and Specialty Chemical Supplier