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Pharma Grade Rigid PVC PE Film For Suppository Packaging

Pharma Grade Rigid PVC PE Film For Suppository Packaging

Water preventing ability of suppository laminate film is 700 times higher than common plastic structure,so it brings better protection to suppositories,and the appearance is more beautiful and high grade. Besides,it also has good rigidty,compression resistance and dilatablility,it is suitable for all kinds of fluid medicine.

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Product Introduction

 

Product Desciption

 

Pharma Grade Rigid PVC PE Film For Suppository Packaging

 

 

Pharma Grade Rigid PVC PE Film For Suppository Packaging is a specialized pharmaceutical blister film engineered specifically for the demanding requirements of suppository packaging. Suppositories present unique challenges-large cavity depth requirements, contact with fatty bases (cocoa butter, Witepsol, hard fat), cold filling processes (5–10°C), and the need for secure sealing to prevent base weeping. This pharma-grade film combines a rigid PVC thermoforming layer with a lipid-resistant PE sealant layer to address all these challenges.

The PVC outer layer provides the structural rigidity needed for deep-draw cavities (up to 14mm), accommodating large suppositories (1–3g). The PE inner layer acts as a chemical barrier, preventing the suppository base from migrating into the PVC and causing swelling or stickiness-a common failure mode in suppository packaging. The PE layer also provides reliable sealing to aluminum lidding, even in the presence of trace fatty residue on the seal surface.

Manufacturing Standards: Produced under ISO 15378:2017 (GMP for pharmaceutical primary packaging materials) with full batch traceability and regulatory documentation for global pharmaceutical submissions.

Key Applications: Analgesic suppositories (paracetamol, diclofenac), anti-inflammatory suppositories (5-ASA, hydrocortisone), hormonal suppositories (progesterone, estradiol), pediatric suppositories, and veterinary suppositories.

 

 

Product Features
Product Name
China factory wholesale rigid suppository pvc pe lanminated film
Color
White
Thickness
0.1/0.03mm or customized
Width
50-750mm
Inner Core Diameter
76mm
MOQ
No MOQ limited
Certificate
ISO 9001,ISO 14001,GMP
Advantage
1.Oxygen, water vapor and aroma barrier
2.Free from plasticisers and heavy metals
3.High gloss and outstanding clarity
4.Wide range of transparent and opaque colours
5.Outstanding thermoforming properties
6.High quality heat-sealing properties & flexibility

 

 

 

 

 

 

 

pvc/pe Film for liquid

 

Key Features – Suppository-Specific Design

 

Deep-Draw Capability – Forms cavities up to 14mm to accommodate large (3g) suppositories without cracking or excessive thinning. Standard PVC films often fail at >10mm.

Cold Filling Compatibility – Remains flexible at 5–10°C (typical suppository filling temperatures). No brittleness or cracking during cold handling.

Lipid-Resistant PE Layer – Does not absorb cocoa butter, Witepsol, or other fatty bases. Prevents swelling, surface stickiness, and seal contamination.

Secure Seal with Fatty Residue – PE-to-lidding seal maintains integrity even if trace amounts of lipid are present on the seal surface. Tested with cocoa butter-contaminated seals.

Pharma-Grade Compliance – Manufactured under ISO 15378:2017 (GMP for pharmaceutical primary packaging). Full batch traceability and regulatory documentation.

Color Options for Light-Sensitive APIs – Clear (standard), Amber (UV-blocking), White (total light block). Amber and white grades available with same PE seal layer.

Print-Ready Outer Surface – Reverse printing on PVC outer layer. White/amber background provides excellent contrast for printed information.

 

Quality Assurance – Suppository-Specific Testing

 

In-Process Controls:

Thickness monitoring – online beta gauge (PVC and PE layers)

PE coat weight – XRF (target ±2 µm)

Formability test – 12mm cavity draw (no cracks)

Color consistency (amber/white grades) – spectrophotometer

Finished Product Testing (Per Batch):

Test Method Specification
Lipid Resistance 40°C/7 days cocoa butter contact No swelling, weight change <0.5%
Low-Temperature Flex 5°C bend test No cracks
Seal Strength ASTM F88 ≥20 N/15mm
Deep Draw 12mm cavity No cracks, no delamination
Haze (clear grade) ASTM D1003 <5%

Certificate of Analysis Includes:

Thickness (PVC + PE)

Lipid resistance test data

Seal strength (with specified lidding)

Deep draw test result

Color specification (if amber/white)

FDA/EU compliance statement

 

 

PVC Film for Cosmetic Packing

Suppository packaging is arguably one of the most underestimated areas in pharmaceutical blistering. Unlike standard tablet blisters, suppositories present unique demands in terms of size, weight, base chemistry, and filling processes. Here are the three most common production-line problems-and how Pharma Grade Rigid PVC PE Film For Suppository Packaging addresses each one:

Challenge 1: Seal Failure Caused by Fatty Base Residue

Common suppository bases (cocoa butter, Witepsol, hard fat) inevitably leave trace amounts of lipid residue on the sealing surface during filling and sealing. Standard PVC film heat-sealed to aluminum lidding can lose 40–60% of seal strength when contaminated with oil/grease. The result is "fatty weep"-the suppository base slowly migrating along the seal edge, causing greasy packaging appearance, consumer rejection, and even product recalls.

How This Film Solves It:
The PE layer is specifically formulated with lipid-repellent additives that maintain seal integrity even when trace amounts of cocoa butter or Witepsol are present on the seal surface. Independent testing shows seal strength retention of >95% after 30 days of contact with fatty bases-compared to <60% retention with standard PVC films. This means fewer leakers, fewer returns, and reduced production scrap.

Challenge 2: Cavity Cracking During Deep Draw Forming

Suppositories are large-typically 1–3g, requiring cavity depths of 10–14mm. Standard PVC films often crack or excessively thin at cavity corners during deep draws, creating stress points that can lead to pinholes and barrier failure. This is particularly problematic on high-speed rotary thermoforming lines where forming cycles are measured in fractions of a second.

How This Film Solves It:
The PVC layer in Pharma Grade Rigid PVC PE Film For Suppository Packaging uses a higher molecular weight PVC resin with optimized plasticizer balance. This provides superior melt strength and elongation at forming temperature (120–145°C), enabling clean, crack-free draws up to 14mm. Wall thickness at cavity corners remains ≥60% of starting thickness-well above the 50% minimum required for structural integrity.

Challenge 3: Cold Filling Brittleness

Suppositories are typically filled at 5–10°C to maintain solid form. At these temperatures, many PVC films become brittle and prone to cracking during web handling, forming, or sealing. The result is line stoppages, web breaks, and material waste.

How This Film Solves It:
The PE layer provides low-temperature flexibility-the film passes 5°C bend tests with zero cracking. This allows smooth running on cold filling lines without pre-heating the web or slowing production speed. Line operators report consistent web handling even during winter months when ambient temperatures drop.

 

Supply Chain Assurance – What Makes This Film "Pharma Grade"

 

The "Pharma Grade" designation on Pharma Grade Rigid PVC PE Film For Suppository Packaging is not a marketing claim. It represents a commitment to pharmaceutical-quality manufacturing standards that many generic film suppliers cannot match:

Supply Chain Element Our Commitment Industry Standard
Raw Material Sourcing PVC resin from ISO 15378 certified suppliers only Some suppliers accept non-certified sources
Production Line Dedicated line for pharma grades – no cross-contamination Shared lines – risk of contamination
Cleanroom ISO 7 (Class 10,000) for slitting and packaging Often no cleanroom
Batch Traceability Full genealogy – resin to finished roll Limited traceability
Change Control 90-day written notice for any material/process change Often no formal change control
Audit Readiness Open to unannounced pharma customer audits Resistance to audit
Retain Samples 5-year retention of every batch 1–2 years
Regulatory Documentation DMF reference letter, full migration studies Basic COA only

What This Means for You:
When you source Pharma Grade Rigid PVC PE Film For Suppository Packaging, you are not just buying film-you are buying documented quality, regulatory support, and supply chain transparency that your QA team can rely on during audits and regulatory submissions.

 

 

 

PVC-PE-Rigid-Film-for-Plastic-Ampoule-Packing-Machine

 

FAQ – Suppository Packaging Focus

 

Extended FAQs – Real Questions from Suppository Manufacturers

Q1: What is the actual seal strength when cocoa butter is present on the seal surface?
We tested seals with 0.5g cocoa butter intentionally placed on the seal area. Seal strength with Pharma Grade Rigid PVC PE Film For Suppository Packaging was 19 N/15mm (vs. 22 N/15mm clean)-retention of 86%. Standard PVC film dropped to 8 N/15mm (36% retention). This is the critical difference.

 

Q2: Can this film be used with high-speed filling lines (200+ cycles/min)?
Yes-we have validated this film on Uhlmann B1240 and Bosch lines at speeds up to 200 cycles/min. The rigid PVC web and low-COF PE layer ensure stable handling at high speeds. For speeds above 200 cycles/min, we recommend a trial to confirm compatibility with your specific machine.

 

Q3: Does the film contain animal-derived ingredients (tallowate, stearate)?
No-this film is 100% synthetic. We provide TSE/BSE-free and animal-origin-free certificates with every batch. This is particularly important for suppository manufacturers exporting to regions with strict halal or kosher requirements.

 

Q4: What is the maximum roll diameter?
Typical roll diameter: 400–500mm. Larger rolls (up to 600mm) available for customers with high-volume production. Roll weight: 50–80kg depending on width and thickness.

 

Q5: Can I get a version with a peelable seal (easy-open for elderly/patients)?
Yes-we offer a peelable PE sealant grade with controlled peel force (8–12 N/15mm). The film otherwise has the same PVC base and deep-draw capability. Minimum order 1 MT for peelable grade.

 

 

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