| HS Code | 953711 |
| Product Name | PVC/PVDC Duplex Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Product Category | Pharmaceutical packaging material |
| Material Composition | Polyvinyl chloride (PVC) film duplexed with polyvinylidene chloride (PVDC) coating |
| Grade | Pharmaceutical grade |
| Primary Function | Moisture, oxygen, and light barrier protection for pharmaceutical dosage forms |
| Compatible Dosage Forms | Tablets, capsules, granules, injections |
| Route Of Administration Compatibility | Oral and injectable |
| Appearance | Transparent to slightly opaque, uniform, glossy film |
| Thickness | Typical PVC layer 250 µm; PVDC coating 40–90 g/m² |
| Water Vapor Transmission Rate | Typically less than 0.5 g/m²/24h at 38°C/90% RH |
| Oxygen Transmission Rate | Typically less than 1.0 cm³/m²/24h at 23°C/0% RH |
| Heat Sealability | Heat sealable to compatible lidding materials |
| Sterilization Compatibility | Ethylene oxide, gamma irradiation, electron beam |
| Regulatory Compliance | USP Class VI, ISO 10993, FDA 21 CFR, EU Pharmacopoeia |
| Storage Conditions | Store in a dry, cool, well-ventilated area away from direct sunlight |
| Shelf Life | 24–36 months from date of manufacture |
| Packaging Format | Rolls, sheets, or custom-cut pieces |
As an accredited PVC/PVDC Duplex Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
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On cam-driven platen blister installations configured for immediate-release tablet packaging, a pharma-grade PVC/PVDC duplex web is fed from the unwind side with the PVDC-coated surface positioned away from the contact heater. The rigid PVC base thickness is selected between 200 µm and 300 µm; a 250-µm base with a PVDC coating weight of 40 g/m², 60 g/m², or 90 g/m² is specified according to the moisture-sensitivity profile of the tablet core. The uncoated PVC face is heated in two zones to 145–155°C before entering a plug-assisted forming station, where the forming surface is held at 120–135°C because PVDC begins thermal discoloration above 170°C and PVC softens around 80–85°C. Cavities for 8-mm diameter compressed tablets are formed to depths of 6–7 mm using a draw ratio of 1:0.7 with plug tip radii of 2.5–4 mm and compressed air at 4–6 bar. The terminal cavity web is sealed against 20-µm hard-temper aluminium lidding coated with 4–6 g/m² of vinyl heat-seal lacquer at sealing jaw temperatures of 160–180°C and dwell times of 0.4–0.7 s. A 60-g/m² PVDC-coated 250-µm PVC web typically exhibits a water vapour transmission rate of not more than 0.8 g/m²/24 h at 38°C/90% RH when tested according to USP <671> or ISO 15106-2, while uncoated PVC of the same thickness is specified in the range of 2.5–3.5 g/m²/24 h. This barrier level is suitable for film-coated tablet cores containing moisture-sensitive active pharmaceutical ingredients when ICH Q1A stability studies support a sealed cartridge with desiccant. The finished primary pack is a 7-, 10-, or 14-cavity push-through blister card overprinted and inserted into a paperboard carton.
The following supplier-reported values are used for initial triage before production qualification:
| PVDC coating weight | Base PVC thickness | Supplier-reported WVTR at 38°C/90% RH | Typical maximum cavity depth | Primary process constraint |
|---|---|---|---|---|
| 40 g/m² | 250 µm | 1.0–1.5 g/m²/24 h | 6 mm | corner barrier loss on tablet sidewall |
| 60 g/m² | 250 µm | 0.5–0.8 g/m²/24 h | 9 mm | PVDC whitening at deep-draw corner |
| 90 g/m² | 300 µm | 0.25–0.45 g/m²/24 h | 12 mm | coating cracking at flange transition |
Published data for specific deep-draw cavity geometries remains limited; these values require verification on the selected production grade and cavity tooling.
Hard-shell capsule blister webs differ from tablet webs in cavity geometry and forming stress. The formed cavity must accept a filled capsule body of 14–22 mm length and 5.3–7.6 mm diameter. Tooling is cut to a draw ratio of 1:0.8 or greater, and plug-assisted pressure forming is required to maintain sidewall thickness. Production-scale trials on intermittent-motion machines have shown that PVDC coating adhesion failure appears as opaque white streaks along the corner radius when cavity depth exceeds 9 mm for a 250-µm PVC/60-g/m² PVDC web. Cross-sectional inspection may show local PVDC thickness loss at the bottom corner, with the effective barrier shift measurable by ASTM F1249 or ISO 15106-2. Published data for this specific deep-draw cavity configuration is limited; however, the visual failure mode is sufficiently reproducible to trigger a grade change to 90 g/m² PVDC and a reduction in forming temperature to 125–130°C. The plug tip radius is reduced to 3–4 mm to distribute material flow, and the compressed air pressure is limited to 5 bar to avoid micro-cracking in the PVDC layer. Terminal capsule blisters are sealed to aluminium lidding at 165–180°C and are used for proton-pump inhibitor pellets, antihypertensive hard-shell capsules, and enteric-coated granules filled into HPMC capsules. Oxygen transmission testing under ASTM D3985 is added for capsule products containing oxygen-sensitive fill oils or polyunsaturated fatty acids; 90-g/m² PVDC grades are specified when the oral dosage form requires an oxygen transmission rate below 2 cm³/m²/day at 23°C and 0% RH. The formed web is also assessed for residual vinyl chloride and extractables under USP <661> protocols before release.
Oral granule wells differ from capsule and tablet cavities by using shallow rectangular cells with large seal areas rather than deep pockets. A typical cell measures 18 mm × 24 mm with a formed depth of 4.0–5.5 mm, which minimizes draw stress and permits the use of 40-g/m² PVDC unless the granulate is highly hygroscopic. For povidone- and lactose-based granulations, the 90-g/m² coating is substituted because the formulation sorption isotherm begins to rise sharply above 35% RH. The sealing process is operated in two stages: a first sealing station applies 40–50 N per cavity at 155°C to activate the aluminium lidding lacquer, and a second cold-pressure station reduces channel leaks before die-cutting. On-line residual oxygen measurement rejects any cell with oxygen content above 3% after sealing, a critical control for granule blends containing ascorbic acid or other oxidation-prone excipients. The PVDC coating is positioned on the product side so that plasticizer migration from the PVC base is retarded; this orientation is particularly relevant when the granule bed contains low-melting fatty acid binders. If the granule product requires a moisture vapour transmission rate below 0.10 g/m²/day, the duplex web is not appropriate and cold-form aluminium/aluminium geometry is substituted. The terminal pack is a 20-well or 28-well card with peelable or push-through lidding, used for oral granules such as potassium citrate and mesalazine unit doses where dosing accuracy and child resistance are required.
Secondary packaging for injection devices does not require the primary barrier of an oral dosage cavity, but the PVC/PVDC duplex web is used in thermoformed trays for prefillable syringes and glass cartridges because the PVDC layer reduces water vapour ingress during cleanroom storage and provides a cleaner peeling surface than uncoated PVC. Trays are thermoformed in an ISO Class 8 packaging hall at web temperatures of 120–130°C to avoid excessive PVC plasticizer volatilization. Cavity layouts for 0.5-mL, 1.0-mL, and 2.25-mL prefillable syringes include finger flange pockets and tip protection recesses. A 40-g/m² PVDC coating is preferred for this configuration because heavy PVDC layers can develop micro-cracks during aggressive finger-flange pocket forming and may contribute particulate matter levels above the limits established in EU GMP Annex 1. The formed tray is sealed with medical-grade Tyvek or coated paper lidding at 130°C; the seal is tested for a minimum peel strength determined by the filling-line operator, commonly in the range of 3–5 N/15 mm under ISO 11607-2. Injectable drug products are never in direct contact with the PVC/PVDC web; the tray is a secondary packaging component only. Qualification includes USP <661> extractables testing, ISO 15378 quality management for primary packaging materials, and bioburden controls under ISO 11737-1 where the tray enters an aseptic filling area. The sealed tray is placed inside a foil laminate pouch with desiccant for storage and transport to the filling line.
Clinical trial packaging lines operate with short batches and repeated tool changes across 5-count, 7-count, 10-count, and 21-count blister cards. The same 250-µm PVC/60-g/m² PVDC web is retained across these configurations to avoid changing web width, unwind tension, and sealing parameters. Recipe-controlled servo drives index the forming station according to cavity pitch; when pitch changes from 72 mm to 78 mm, the upper preheat zone is held at 125°C because higher temperatures cause PVDC embrittlement at the punch edges. Quality assurance after every tool change includes a WVTR measurement on a formed cavity sidewall, because PVDC thickness loss at pitch-change edges is the main source of barrier variation. ASTM F1249 or ISO 15106-2 is used to confirm that the formed 60-g/m² grade remains below 0.8 g/m²/24 h at 38°C/90% RH. For blinded investigational products with limited stability data, the protocol may require moisture ingress not exceeding 0.5 g/m²/day; if that limit cannot be maintained after forming, the material is replaced by cold-form aluminium laminate for that production campaign. The clinical trial card containing blinded oral dosage forms or injectable device trays carries subject identification codes and is overwrapped in a desiccated pouch. This segment relies on the duplex web only when the trial protocol permits a measurable water vapour ingress window; otherwise the packaging engineer switches to higher-barrier foil construction.
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The product designated PVC/PVDC Duplex Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is a rigid poly(vinyl chloride) substrate with a continuous poly(vinylidene chloride) barrier layer applied to the seal side. It is supplied as rollstock for thermoformed blister cavities, push-through packs, and tray structures used with immediate-release and modified-release tablets, hard gelatin and hydroxypropyl methylcellulose capsules, granulated active pharmaceutical ingredients, and powder components of reconstitution kits. The material is specified as the formed web in pharmaceutical primary packaging and is normally sealed against aluminium lidding foil with a heat-seal lacquer. It is not specified as a primary contact material for terminally sterilised aqueous injectable solutions; glass vials, cyclic olefin polymers, or coated elastomeric closures are used in those systems. For dry powder injection packaging, the duplex film can serve as a secondary tray or cavity material, but published data for use of thermoformed PVC/PVDC as a direct wettable contact layer for injectable liquids is limited. The product family is ordered by nominal PVC thickness and PVDC coating weight; common forms include 200/40, 250/40, 250/60, 250/90, and 300/60.
A rigid PVC base layer is calendered or extruded from unplasticised suspension homopolymer with a K-value typically between 57 and 60, a density of approximately 1.38 g/cm³, and a glass transition temperature near 80 °C. The PVC base film is normally supplied with machine-direction tensile strength of 45–60 MPa and elongation at break above 100 % when tested according to ISO 527-3. The PVDC barrier layer is deposited from an aqueous or solvent-based vinylidene chloride copolymer dispersion to a dry coating weight of 40 g/m², 60 g/m², or 90 g/m²; the dry PVDC density is approximately 1.65 g/cm³. The coating is continuous across the web, but edge trim zones and splice regions are not considered specification surfaces for packaging. Supplier acceptance criteria commonly allow PVC thickness tolerance of ±5 % and PVDC coating weight tolerance of ±10 %. The film is slit to widths from 80 mm to 800 mm with core internal diameter 76 mm and roll lengths from 300 m to 1000 m, depending on gauge. The material is transparent or tinted; amber tinting is available for light-sensitive formulations, but the UV-blocking capacity should be confirmed by spectrophotometric testing of the formed cavity because the PVDC layer is not a designated UV filter.
| Configuration | PVC base gauge | PVDC coating weight | WVTR range at 38 °C/90 % RH (ASTM F1249-20) | Common use |
|---|---|---|---|---|
| 200/40 | 200 µm | 40 g/m² | 1.0–1.6 g/m²·d | High-speed lines for non-hygroscopic tablets |
| 250/40 | 250 µm | 40 g/m² | 0.8–1.5 g/m²·d | Moisture-sensitive oral solids |
| 250/60 | 250 µm | 60 g/m² | 0.5–1.0 g/m²·d | Humid climate zone distribution |
| 250/90 | 250 µm | 90 g/m² | 0.3–0.6 g/m²·d | High-barrier oral solid dose |
| 300/60 | 300 µm | 60 g/m² | 0.4–0.9 g/m²·d | Large cavities and hard gelatin capsules |
Barrier performance is derived primarily from the PVDC layer. Uncoated 250 µm PVC shows WVTR in the range 2.8–3.2 g/m²·d at 38 °C and 90 % RH; a 40 g/m² PVDC coating reduces permeability by roughly 60–85 %, and a 90 g/m² coating can reach 90 % reduction relative to the uncoated substrate. Oxygen transmission rate measured by ASTM D3985-17 follows a similar direction; published supplier values for the 90 g/m² duplex film are typically below 2 cm³/m²·d·bar at 23 °C and 0 % RH, compared with 80–150 cm³/m²·d·bar for uncoated rigid PVC. The table values are not specification limits; they are representative ranges from supplier technical bulletins and must be confirmed on the exact gauge, PVDC copolymer composition, and sealing lacquer.
Thermoforming on rotary machines requires contact heating of the PVC side because direct heating of the PVDC face can create surface tack, coating transfer, and premature cross-linking. Flat-plate machines set preheating plate temperatures between 120 °C and 150 °C for 250 µm duplex film, with plug-assist temperature controlled at 60–80 °C and forming air pressure at 4–6 bar. On rotary lines running shallow tablet cavities at 250–400 blisters/min, contact heater temperatures are typically 140–170 °C; thicker 300 µm or 350 µm films require higher heat input or reduced line speed. Twin-track flat-plate machines processing 200/40 film for capsule cavities generally operate at forming temperatures of 125–135 °C. The practical processing window on rotary lines is within ±5 °C of the setpoint for thin 200/40 films because underheating produces incomplete cavity definition and overheating produces PVDC tack on forming plugs. Cavity geometry must maintain corner radii above 2 mm and a draw ratio below approximately 0.5–0.6; deeper draw ratios produce corner thinning and PVDC microcracking that appears as white striations under polarised light. The film should be conditioned at 20–25 °C and 40–60 % RH for 24 h before thermoforming to reduce curl and static-induced misfeeding. Storage outside this humidity window can produce edge curl and sealing-lacquer defects; rolls should be reconditioned before use. Batch-to-batch variance in PVDC coating weight on slitting lines is principally observed as seal-strength drift at the web edge; operators should sample both edges and centre because slitting tension can alter coating thickness distribution and because centre-to-edge gauge variation may exceed 5 % on wide webs.
PVDC functions as both barrier and heat-seal receptor, but the sealing window is narrower than for PVC monofilms. Representative sealing conditions against aluminium lidding foil with a compatible heat-seal lacquer are 160–190 °C crimp head temperature, dwell time 0.6–1.2 s, and sealing pressure 3–5 bar. Sustained seal-head residence above 200 °C causes dehydrochlorination of the PVDC layer, visible as amber discoloration on the crimp pattern and a characteristic HCl odour. The same failure can occur when machine stoppage leaves film stationary under heated sealing tools; automatic seal-head lift or rapid cool-down should be enabled. Seal integrity tests based on destructive burst testing and dye penetration should be performed at start-up and after every film splice. Delamination at the PVC/PVDC interface is commonly traced to insufficient corona or primer treatment on the PVC web, leading to channel leaks around the blister perimeter. The specification should include a peel-adhesion acceptance value for the PVC/PVDC interface; a typical lower limit is 0.6 N/15 mm when tested by a 180° peel method, but the exact limit is grade-dependent and should be derived from sealing-lacquer compatibility data. Air entrapment between PVDC and aluminium lidding foil is another failure mode; knurl geometry, sealing pressure, and dwell time should be adjusted so that air channels are eliminated without crushing the cavity flange.
For solid oral dosage forms containing moisture-sensitive APIs, selection among PVC/PVDC, PCTFE/Aclar triplex, COC/PVC, and cold-form aluminium depends on the permitted water vapour ingress over shelf life. PVC/PVDC retains a transparent thermoformed cavity and can run on existing PVC lines with minor adjustments. The duplex film is less barrier than PCTFE laminates of comparable thickness; however, PCTFE requires a triplex construction and carries a significantly higher material cost per square metre. Aluminium cold-form blisters provide the lowest moisture ingress but are opaque, increase package volume, and require higher forming forces. COC-containing films improve moisture barrier relative to PVC but have different heat-seal and trimming behaviour. EVOH-based structures provide high oxygen barrier only at low relative humidity; the oxygen barrier of EVOH decreases sharply above 60–75 % RH, whereas PVDC barrier remains more stable under humid storage. The PVC/PVDC duplex is therefore used where a moderate barrier improvement over PVC is required without changing the blister machine infrastructure. The primary differentiation from a plain PVC monofilm is the PVDC sealing-side barrier; the product should not be confused with PVDC-coated lidding foil or with a PVC/Aclar/PVC triplex, because the forming-side thermal behaviour and barrier contribution are not equivalent.
If the packaging specification demands WVTR below 0.5 g/m²·d under ASTM F1249-20 at 38 °C and 90 % RH, the 90 g/m² PVC/PVDC duplex may meet the requirement only when cavity geometry and seal area are optimised. The overall package permeation depends not only on the web WVTR but also on the formed cavity surface area, web thinning, seal width, and lidding foil quality. Thinning at the cavity corners can reduce local PVDC thickness by 10–20 %; therefore the flat-sheet WVTR value cannot be directly used to calculate shelf life without a forming factor. For regulatory submission, moisture ingress should be measured on the formed blister or, if that is not available, simulated using a finite-element diffusion model with corrected thickness distribution. If the calculated package-level moisture ingress falls above the stability budget, the next step is a 90 g/m² duplex with increased seal width, a PCTFE triplex, or a cold-form aluminium laminate. The transition from 250/40 to 250/90 increases PVDC coating weight but does not change the PVC forming force; therefore the same cavity geometry can usually be retained.
Material suppliers are expected to provide a written statement that the PVC base layer complies with Ph. Eur. 3.1.11 and that the PVDC coating complies with 21 CFR 177.1630 for vinylidene chloride copolymers. The final formed packaging system is evaluated under USP 661.1 for plastic materials of construction and USP 661.2 for plastic packaging systems, with extractables assessment conducted under USP 1663 and leachables under USP 1664 where the dosage form is injectable or high-risk. The supplier should also report residual vinyl chloride monomer content below 1 ppm and residual vinylidene chloride monomer below 5 ppm by headspace gas chromatography. Barrier test certificates should state the instrument type, conditioning protocol, and standard method: ASTM F1249-20 for WVTR and ASTM D3985-17 for oxygen transmission. The product should be stored at 15–25 °C and 40–60 % RH; exposure to direct sunlight and UV sterilisation should be avoided because PVDC undergoes photolytic darkening. The operational boundary for the duplex film is defined by thermoforming temperature, seal-head dwell, and storage humidity rather than by chemical incompatibility with solid oral dosage forms; contact with amine-based liquid formulations is not specified and should be avoided unless supported by extractables data.
