Products Description
Regulatory-Compliant PVC/PVDC Film with Full Traceability for Pharmaceutical Primary Packaging
What it is:
A rigid PVC/PVDC blister film manufactured under full material traceability from raw resin receipt to finished roll. Every kilogram of film can be linked back to specific lots of PVC resin, PVDC dispersion, plasticizers, and processing conditions. Designed to meet the documentation requirements of pharmaceutical companies filing Drug Master Files (DMF) or submitting to EU, FDA, MHRA, and WHO.
Why "full traceability" matters for pharma:
Regulators require that any primary packaging material be traceable in case of a defect or quality issue. Without lot-level traceability, a single contamination event can force a recall of millions of packs. Our TraceRx system records data at six control points and provides a complete Certificate of Analysis (COA) with batch genealogy.
Construction:
Base layer: PVC (clear or white) – 200–350µm
Barrier coating: PVDC (standard or high barrier) – 40–90 g/m²
Optional sealant: PE or heat-seal lacquer (PE for easy sealing, lacquer for low-temperature)
Traceability scope:
PVC resin: supplier, lot number, date of receipt, silo storage location
Plasticizers & stabilizers: individual batch numbers, mixing ratios, expiry
PVDC dispersion: manufacturer, batch, viscosity, solids content
Coating parameters: line speed, drying temperature, coating weight target
Slitting & packaging: operator ID, inspection results, roll serial number
Available formats:
Widths 100–1200mm; roll lengths up to 3000m; core 76mm
Key Advantages (Regulatory & Traceability Focus)
Complete "cradle to gate" traceability
Each roll receives a unique GS1-128 barcode that encodes: product code, batch number, manufacturing date, and a serialized roll ID. Scanning the code instantly retrieves the full batch record from our secure server – including raw material certificates, in-process QC, and final test results.
Designed for DMF and ANDA filings
We provide a Drug Master File (DMF) Type III (packaging material) that you can reference. The DMF contains complete chemistry, manufacturing, and control information. No need to generate your own data – we supply the package.
Change control notification
We contractually agree to notify you 90 days in advance of any change in raw material supplier, manufacturing site, or specification. This complies with ICH Q7 and FDA 21 CFR 211.94(c). Many film suppliers do not offer this.
Reduced audit burden
Your quality team can request our Supplier Quality Technical Agreement and Audit Report Summary (redacted). We have been audited by five major pharma companies (names disclosed under NDA) and passed with zero critical findings.
Segregated production line
TraceRx films are manufactured on a dedicated line that never processes non-pharma grades. No risk of cross-contamination with industrial or food-grade materials.
Permanent inkjet marking on each roll
Every roll is side-stamped at 5m intervals with batch number and "TraceRx" logo. Even if the outer label is lost, the roll remains identifiable.
In-process testing (performed on each master roll):
Thickness profile (ASTM D374) – 20 points across web
Seal strength (PE sealant version) – ASTM F88
PVDC adhesion – tape peel test
OTR & WVTR (MOCON) – one sample per 5000m
Clarity/haze (ASTM D1003)
Residual solvent by GC (headspace) – quarterly, or per customer request
Retain samples:
We keep a 1m² sample from every master roll in a climate-controlled vault for 5 years (or longer by agreement). The sample is labeled with the same batch number and can be retrieved within 24 hours for any investigation.
Electronic batch record (EBR):
All data is stored in a read‑only, time‑stamped database with full audit trail (compliant with 21 CFR Part 11). You can request a read‑only login to view your batch records online.
Certificate of Analysis (COA) includes:
Batch genealogy (raw material lot numbers)
All test results with specification limits
Statement of compliance with EU 10/2011, FDA 21 CFR
Date of release and expiry of film shelf life
Digital signature of QA manager
Performance Data (Regulatory Grade – Standard Barrier)
Because traceability does not alter physical properties, the performance of TraceRx film matches standard pharmaceutical PVC/PVDC. Below are typical values; we will qualify to your specific requirement.
| Property | Typical value | Test method |
|---|---|---|
| OTR (23°C, 0% RH) | 3.5–6.0 cm³/m²·day | ASTM F1927 |
| WVTR (38°C, 90% RH) | 1.5–3.0 g/m²·day | ASTM F1249 |
| Haze (clear grade) | <4% | ASTM D1003 |
| PVDC coat weight | 30–60 g/m² | XRF |
| Seal strength (PE sealant, 140°C) | >25 N/15mm | ASTM F88 |
| Modifier content (if impact grade) | 0% (standard) or as ordered | FTIR |
| Total thickness tolerance | ±3% | ASTM D374 |
Note: For barrier-critical drugs (e.g., nitroglycerin tablets), we can provide high-barrier PVDC coating with OTR <2.0 – same traceability system applies.
Packaging (Traceability Extension to Shipping)
Primary packaging of the film:
Each roll is sealed in a moisture-barrier bag made of aluminum foil laminate. The bag is heat-sealed and labeled with a GS1-128 label containing:
(01) Global Trade Item Number (GTIN)
(10) Batch number
(21) Serial number (unique per roll)
(11) Manufacturing date
(91–99) custom fields: e.g., roll length, width, thickness
Secondary packaging (carton):
The carton label repeats the batch number and includes a tamper-evident seal. We also place a miniature QR code inside the carton flap that links to an online video showing the QC testing of that batch (optional, free).
Pallet labeling:
Each pallet has a license plate barcode that aggregates all roll barcodes. A packing slip lists every roll's serial number for easy receipt verification.
Document pouch:
Attached to the outside of each pallet is a waterproof pouch containing:
Signed Certificate of Analysis (hard copy)
Certificate of Compliance to EU/FDA
Material Safety Data Sheet (MSDS)
Instructions for storage and use
Sample packaging for regulatory trials:
We ship samples in sterile, sealed pouches with a chain‑of‑custody form. Each sample is accompanied by a mini‑COA and a declaration of traceability for that specific cut.
Product Applications (Pharmaceutical Primary Packaging)
Solid dosage forms (tablets, capsules):
Standard blisters for antibiotics, analgesics, vitamins, antidiabetics
High‑humidity regions: our traceability helps with stability documentation
Hygroscopic drugs:
Use with high-barrier PVDC. Traceability ensures batch‑to‑batch consistency of WVTR.
Ophthalmic & topical solid inserts:
Small, low‑volume blisters where any packaging defect is critical.
Clinical trial supplies:
Full traceability is mandatory for blinded studies. We provide double‑blinded labeling option – only your CRO can decode the batch.
Generics exporting to regulated markets:
Having a DMF‑ready supplier simplifies your regulatory filing in US, Europe, Canada, and Australia.
Not for:
Liquid-filled blisters (use cold‑form foil or specific liquid barrier).
Sterile packaging that requires terminal sterilization (but can be used for non‑sterile blisters in a sterile suite – ask for our cleanroom packing).
FAQ (Pharma Traceability Focus)
Q1: What exactly does "full traceability" mean for a roll of film?
A: It means we can tell you, for that specific roll: which PVC resin lot, which PVDC batch, which stabilizer lot, which operator ran the coating, the date and time of production, the QC results at each stage, and the final inspection log. We can produce this in under 15 minutes from our database.
Q2: Do you provide a Drug Master File (DMF) that I can reference?
A: Yes. We have filed a Type III DMF with the FDA (DMF number available on request). You can reference it in your NDA/ANDA. For EU, we provide an equivalent "Certificate of Suitability" (CEP) package for PVC/PVDC (though CEP is not mandatory, we supply all necessary data).
Q3: How do you handle change control?
A: We sign a Quality Technical Agreement that includes a 90‑day notification for any change in raw material, process, equipment, or site. If you request no change without prior approval, we honor that. No surprises.
Q4: Can I audit your facility before purchasing?
A: Yes. We welcome quality audits (onsite or remote). We provide a vendor questionnaire response first. Audit costs (if onsite) are shared – you pay travel, we provide meeting space and documentation.
Q5: What is the lead time for a traceability‑compliant sample?
A: We keep "pharma‑grade master rolls" in 3 common thicknesses (220, 250, 300µm) ready for slitting. Sample roll (20–50 kg) can be shipped within 5 working days, complete with a full COA and traceability report.
Q6: Do you offer serialized roll numbers for our ERP integration?
A: Yes. We can send an ASN (Advanced Shipping Notice) file in XML or CSV format before shipment, listing each roll's serial number, batch, and weight. You can upload this directly into your SAP or Oracle system.
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