Blister Packing Machine is mainly used to form, fill and seal pharmaceutical products like tablets, capsules in blister pack. In operation, PVC or Aluminum base film web is drawn off from a reel and fed into the blister-forming unit where blisters are continuously formed. The web is then led to the sealing unit over a guide track. Over the guide track, the product is filled into the blisters by suitable automatic filling unit or manual feeding before the web enters the sealing unit. Aluminum foil is drawn off from a separate reel and is fed to the sealing unit where it is sealed with the base web, thus enclosing the product hermetically
The filled and sealed web is then fed by an indexing mechanism into the pack punch unit where the packs are separated from the web. The web trim is sheared off to allow collection. The blister pack may either be collected in bins or may be conveyed over a belt for further handling.
The Packaging machine will be used for packing coated and uncoated tablet in Blister Strip as primary packaging. After blistering, it will be carried out for secondary packaging – Auto cartoning Machine or Manual Packaging.
Capacity: 500 – 600 blisters/min.
Type: Both for Alu-Alu & Alu –PVC/PVDC
MACHINE SPECIFICATIONS
Operations
The machine should have following features in its respective parts –
Station
Machine must cover Pre-heating, forming, feeding, sealing, cooling, perforation or Slitting, embossing, punching (Die cutting) stations
Hoppers
Complete with bowl, vibrator, tray and sorter.
Feeding to hopper
Manual. By loader & Vacuum (optional).
Both the optional items should be quoted separately.
Must be closed system.
Feeding to pouch
Automatic feeding device required with brush, after feeding exhaust housing etc. (Type will be depended on the tablet size & shape.)
Separate price quotation required for Universal Brush Box Feeder, Track Feeder, Shutter Gate Feeder or any other type.
Must be closed system.
Sealing
Optimum sealing must be ensured by servo or any other mechanism.
Change Over
Change over must be quick & easy in order to reduce the time.
A set of tools must be provided to assist the removal and replacement of change parts.
Required number of change part will be finalized later on.
Machine Specifications
Indexing System
Self-indexing by servomotor.
Servo motor actions at various stations like heating, perforation, punching etc.
Empty Pouch detection & Auto Rejection(Online Camera)
Must detect empty pouch, different or irregular tablet, chipped tablet etc.
There will be marking on the defective blister.
Reject the defective particulate blister only at the end.
Measuring & Controlling System
Sorting of ‘out of specification’ tablets at high speed.
There might be on line sample collection option. (Optional)
Duster Collector
Should be quote as an optional item separately.
Chiller
Inbuilt and almost sound less.
Auto Cartoning & Online Weight Measuring
Should be quote as an optional item separately with detail specifications.
Interchangeability
Incase of several machines of same type must have to interchange facility of changeable parts of machine.
Materials to be used
All parts of equipment in contact with the product shall be stainless steel AISI 316 or AISI 316L
Other materials compliant with FDA Regulation e.g. PTFE, Silicon or viton rubber.
Surface that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive.
Product contact surface shall have a surface better than Ra 0.5 micron.
All product contact lubricants shall be food grade.
All non contact MS parts must be cladded with AISI 304
Cleaning
The design and construction of the equipment should be such that sharp angles and corners and other parts those are not easily accessible for cleaning are avoided.
All parts have to be designed in such a way that it can be dismantled easily for cleaning.
Machine should be modular design to have easy cleaning facility.
Supplier shall provide detail cleaning procedure & validation method.
Design & Construction
Design and construction should be as per European Medicine Agency (EMA) and FDA regulation and guidelines.
Heat Insulation
During normal operation, no external part of the equipment should reach a temperature in excess of 550C.
Where parts are likely to attain a temperature in excess of 550C, they should be insulated with mineral or chemical insulating materials and clad. For those parts in the pharmaceutical zone, this cladding shall be in stainless steel (AISI 304).
Electrical Requirements
All electrical equipment located in process areas should be rated to IP55 (dust proof and protected against water jets) unless specified otherwise and terminations within the machine made in sealed junction boxes.
Electrical equipment located in non-process technical (plant) areas should be rated to IP41 minimum.
The PLC controls the process and acquires data from it. Via HMI the operator is able to feed parameters and control commands for PLC. HMI visualizes the process and the functioning of the equipment to operator.
All programmes are initiated from the standby phase as indicated on the operator panel.
All text signs on control buttons; switches, operator panel etc shall be in English language.
Minimum protection class of control cabinets placed outside the clean room is IP54. Surface epoxy painted (not required for plastic materials).
