Alu Alu Blister Pack Machine
Table of Contents
|6||Commissioning and Documentation|
|S. No.||Parameters||Required Specifications|
Ø Base film-loading station.
Ø Pre-forming base film platen heating station..
Ø Cold forming station.
Ø Feeding systems which are product, layout or base foil dependent.
Ø Web transport station.
Ø Sealing Station for sealing of the base film to the lidding film.
Ø Embossing on the sealing station.
Ø Film indexing station.
Ø Punching station.
Ø Trim winding assembly.
This system is used to for small consumer goods, foods, and for pharmaceuticals.
The primary component of a blister pack is a cavity or pocket made from a formable web, usually a thermoformed plastic. This usually has a backing of paperboard or a lidding seal of aluminum foil or plastic. Blister packs are useful for protecting products against external factors, such as humidity and contamination for extended periods of time. Opaque blisters also protect light-sensitive products against UV rays.
Allocated floor space for the equipment is with a clear ceiling height of 3 Mts. Approx.
To be installed in 4.5×4.5 Mts. Area.
(i) Room Temperature NMT 27 degree C
(ii) RH 45-55%
(iii) Non flame proof area
As per Annexure-1
Material of Construction
|(i) Unit to be compact with ease of operation.
(ii) Ease of maintenance
(iii) Easily cleanable
(iv) All gaskets provided to avoid leakages should be amenable for easy removal and re-fixing,
(v) All electrical / pneumatic parts should be pre wired.
(vi) Complete safety interlock design
(vii) All bolts, nuts on the exterior part of equipment to be preferably with cap head or cap nut.
(viii) Parts which are required for cleaning should be provided with quick fixing arrangement
The equipment body should be SS 304,SS 316 L.
Power failure / recovery
|Max. Speed – 50 cycles / Minutes
Max Forming Area -140X220 MM
Min Pack Size – 30x60MM
Optimum Forming Depth –18MM
Max Reel Diameter – 440 MM
Max Lidding Foil – 226 MM
Max Core Diameter -70 to 76 MM
The system shall operate with a minimum of operator involvement. Operation shall be safe from an operator and environmental standpoint.
The system shall be operated locally at the equipment itself
Connected Load (Kw) – 15 KW
Average Power Consumption – 5 KW
(Approx.) Supply 3 Phase, 4W+E – 4 Wire + Protective Earth-in
Cooling Water Consumption –120 – 150 Ltr/Hr
Compressed Air – 16 CFM
Machine’s Dimensions- Approx. in mm
In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention of re-start
Depending upon the options chose in the overview section, the system will:
i. Manually restart based on operator inputs (operator initiates power recovery sequence).
|To provide utilities at ONE POINT is user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.|
|5.||Maintenance||Supplier should provide (at minimum) the following maintenance instructions,
i. Maintenance and operation manuals alongwith as built drawings
ii. Lubrication instructions
iii. Daily checks on machine
vi. Cleaning procedures
|Commissioning and Documentation
| The Supplier will submit DQ (Design Qualification) document.
· IQ/OQ/PQ to be completed by the supplier along with Company representatives.
· The Supplier to demonstrate the Performance of the machine at site as per agreed terms.
· The Supplier to submit the following certificates:
· MOC Certificates.
· Calibration certificates of all the instruments used having traceability to NPL / NIST
· Performance certificates of Tests conducted
· At manufacturers/Supplier end for Motors / Gear Box / Fan and other critical bought out items with Serial nos.
The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
Start up support
Post start up support
Supplier to train the respective technical associates of on operation, maintenance and cleaning of the equipment wherever applicable
Telephone / Fax / E mail ID / Address
Replacement parts availability list (normal lead times shall be listed).
System improvements (supplier shall notify user of any improvements.
|Packaging||Supplier to specify packaging of machine for safe transportation and delivery at the site|
|Deviations||Any deviation from URS shall be highlighted.|
|As per purchase order. To be delivered at :
|URS||:||User requirement specifications|
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube