PVC
The most basic material for the forming web is PVC or Polyvinyl Chloride. The principal advantages of PVC are the low cost and the ease of thermoforming. The main disadvantages are the poor barrier against moisture ingress and oxygen ingress; moreover PVC has a negative environmental connotation due to its chlorine content. In the case of blister packaging the PVC sheet does not contain any plasticizer and is sometimes referred to as Rigid PVC or RPVC. In the absence of plasticizers, PVC blisters offer structural rigidity and physical protection for the pharmaceutical dosage form. On the other hand, the blister cavity must remain accessible by the push-through effect and the formed web may not be too hard to collapse when pressed upon; for this reason the PVC sheet thickness is typically chosen between 200µ to 300µ depending on the cavity size and shape. Most PVC sheets for pharmaceutical blisters are 250µ or 0.250 mm in thickness. Typical values for the Water Vapor Transmission Rate (WVTR or MVTR) of a 250µ PVC film are around 3.0 g/m2/day measured at 38°C/90%RH and the Oxygen Transmission Rate (OTR) is around 20 cc/m2/day. In order to overcome the lack of barrier properties of PVC film, it can be coated with PVDC or laminated to PCTFE or COC to increase the protective properties. Multi-layer blister films based on PVC are often used for pharmaceutical blister packaging, whereby the PVC serves as the thermoformable backbone of the structure. Also, the PVC layer can be colored with pigments and/or UV filters. The European Pharmacopoeia (EP) references the requirements for PVC blister packs for pharmaceutical primary packaging in the monograph EP 3.1.11 “MATERIALS BASED ON NON-PLASTICISED POLY(VINYL CHLORIDE) FOR CONTAINERS FOR DRY DOSAGE FORMS FOR ORAL ADMINISTRATION”. In order to be suitable for pharmaceutical blister packs, the PVC formulation also needs to comply with the US Pharmacopoeia <661>; EU food legislation; US 21.CFR and Japanese food contact requirements.
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