Alu Alu Blister Pack Machine

Alu-Alu Blister Pack Machine

Table of Contents

General
Salient Features
Operational Requirements
Utilities
Maintenance
Commissioning and Documentation
Training
Packaging
Deviations
Delivery

TECHNICAL 

General/Equipment No./Description/Use

Required Specifications

Equipment No.

It contains

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.

Field Identification

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

Salient Features / General

(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

Material of Construction – The equipment body should be SS 304,SS 316 L.

Electrical Construction –  Non flameproof

Operational requirements

Capacity :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

Control Parameter –

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

Functional Requirements

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

Machine Width : 1200

Machine Height : 2000

Machine Length : 4000

Power failure / recovery

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).

Utilities

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.

Maintenance

Supplier should provide (at minimum) the following maintenance instructions,

i. Maintenance and operation manuals along with 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.

Development

The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.

Training

Start up support : Supplier to train the respective technical associates of  on operation, maintenance and cleaning of the equipment wherever applicable
Post start up support :

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.

Delivery :As per purchase order. To be delivered at :

Company Address

Annexure-1

GLOSSARY

URS:User requirement specifications
DQ:Design Qualification
IQ:Installation Qualification
OQ:Operational Qualification
PQ:Performance Qualification
0C:Degree Celsius

 

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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

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