User requirement specification for blister packaging machine
Blister packaging machine with be set out on the first floor, the capacity will be used for dietary supplement and medicines blistering processes.
Blister packaging machine must be automatic and have a capacity of 170 to 200 blisters per min.
Parts of the blister machine in contact with the product must be steel made, type 316 L (SS 316L).
Option of combined blistering process using PVC/Al, PVDC/Al foil, as well as cold form Al/Al foil is also demanded.
Tool removal time should be no longer than 30 minutes.
Blisters must have total size of 65 x 90 mm in dimensions and for 10 capsules packaging.
Appropriate technical data sheets are required, instructions for use and other reference documents according to GMP specifications and rules. Machine diagnosing
services and trial work period using sample capsules for the machine is requested.
Blister Machine must have general work part: propellant motor, foil winding mechanism, and foil embedding line (blister forming section). Blister Machine work must be supported by compressed air.
Control parts must provide the separation of empty, poorly closed blisters, as well as blister count.
Safety system must be able to automatically stop machine processes if irregular machine work is experienced.
Protection system must stop blister machine process if work irregularity occurs.
An appropriate display showing work parameters and providing dials for blister machine control is desired.
A continual electric current and compressed air supply must be provided for blister machine operation.
Supplier must provide training services regarding maintenance and machine operation that do not require official service engagement.
Installed equipment starting from installment and verification completion must have 2 year warranty.
Warranty must cover in place assessment and repair services in case of component manufacturing has suffered a factory error.
Service provider must inform user on any cases of product recall due to hidden defects or safety issues within the blister machine.
Machine supplier must provide maintenance services in both warranty period and after. Reaction time for services will be defined in the contract. Service provider must also provide spare parts in accordance to defined criteria in case of machine malfunction.
Blister machine commissioning. Commissioning during handover implies:
Electric installation check. Blister machine work verification.
Control parameter verification. Display performance verification
Blister machine qualification process. Installation and operational equipment qualification is required (IQ, OQ).
Performance qualification is required, in agreement with the service provider (PQ).
Documentation must be provided in both Serbian and English translations.
Instruction for use must contain information on general appearance, machine function, turn-on procedure, installation and maintenance processes instructions