Blistering Machine

To describe the procedure for validation of the blistering machine to ensure that it meets installation, operational, and performance qualihcation requirements 

It is the responsibility of the production manager and technical services manager to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

Thermoforming station (pocket depth, pocket rupture) Forming head pressure and pressure distribution Cooling water supply for heated and cooled tools Vacuum exhaust system Empty hopper detector Fill control system 

Sealing station overload protection Cooling station 

Perforating station (foil strain shift and perforation presence) Compensation loop before punching station Punching station (foil strain shift) 

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Time interval prior to daily blistering machine start every 2 during production... 

Blister machines utilise the fact that a plastic film can be softened by heat and then formed in a mould by ... 

Greater emphasis has been put on blister packaging systems in recent European developments. Most machines can be coupled with a leaflet/cartoning system. In many instances the cartoning operation is an integral part of the blister machine. 

Mobile Blister Machines, and deblistering—The neglected aspects ... 

In addition to catering for conventional thermoformed blisters using a plastic tray and a foil-based lid, most blister machine manufacturers now offer facilities to increase moisture protection, by use of either a tropicalised blister (by an additional foil over cover) or a cold formed, foil-based tray. Considerable competition is expected between these and similar options, where a high level of climatic protection is required. The other options include blisters in sachets and overwraps to cartons. Output speeds, climatic protections achieved, overall cost and patient/marketing preference, will influence the final pack choice. 

Hard PVC is used for blister packages. It is preheated in a blistering machine and then round or capsule-like cavities are being formed in a moulding station. PVC is relatively permeable to water vapour and therefore not suitable to contain hygroscopic tablets or capsules. However, water permeability is greatly reduced when the PVC-film is combined with a thin layer of PVDC (polyvinylidene chloride). 

A blister pack or strip is a container with a foil that is shaped so that it can contain separate dosages [26]. An aluminium lidding foil closes the form foil. Blisters are mostly used to package tablets or capsules. For blister packs a form foil of PVC or laminate of PVC/PVDC (polyvinylidene chloride) is used. The form foil is warmed in a blister machine and a mold station makes round or capsule-Uke pockets with compressed air. PVC is permeable to water vapour and therefore not suitable for tablets or capsules that are moisture sensitive. To package such products the PVC form foil should include an outside layer of PVDC. PVDC permeates less water vapour. Dependent on product sensitivity to moisture, different PVDC-thicknesses can be chosen. When complete resistance to water vapour is necessary a form foil that consists of a formable aluminium laminate (consisting of polyamide, soft aluminium and PVC) has to be used. 

Costs are related to material prices, output speeds, wastage, machine depreciation, downtimes, etc. (see below). Depending on the choice of material, blister packs of the push-through variety can be as economical as glass bottles in quantities up to around ninety items per pack. At quantities below twenty-five items, there are positive cost advantages in most cases. Both these comments must be accepted as rather general statements—the actual break-even point has to be calculated for each set of circumstances. The above indications assume that both a glass bottle and the blisters have to be packed into cartons, with a CRC fitted to the bottle pack. 

A broad summary can be made of machines, materials, outputs, costs, etc. in comparison with glass and plastic bottles, metal cans, and strip packs as shown by the general costings. As the requirement for a unit dose or multiple unit dose increases, both blister and strip packs are ensured of a significant increase. Blisters may gain in space and cost saving but lose out in climatic protection, unless cold formed foil, a foil tropicalised blister, or an overwrapping system is used. 

New machines, cold forming, a plastic/foil blister/pocket, which use areas of materials between those of blisters and strips are also likely to increase. Whether these are actually strips or blisters will depend on the forming process used. 

The pharmacist normally purchases the blisters in reels, and has a special sealing machine for the lidding operation. The pockets can usually be individually labelled (on the lidding) using a computer-based system involving self-adhesive labels. 

Strip packaging machines are far simpler and smaller than blister packaging units, usually simply consisting of a feed system, product insertion plus heat sealing, and a guillotining operation to size. 

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