EQUIPMENTS

What is an
equipments..???
Equipment may be defined as a
physical entity which is used to
carry out a general or specific
activity in the plant.
 Types of Equipments

Single piece
 E.g- tablet compression m/c, a
mixer, HPLC, FTIR, weighing balance
etc.
Integrated system
 E.g- water demineralising plants, an
air handling system etc.
 Management of Equipments in
Pharmaceutical Plants as per International
GMP Literature

 Location
 Design
 Construction
 Size
 Adaptation
 Cleaning & cross-contamination
 Preventive & Breakdown maintenance
 Contd……

 Installation,calibration, qualification,
validation
Automatic, mechanical, electronic equipment,
including computers
 Filters
 Weighing balance
 Life cycle of an Equipment

 Decision to purchase an Equipment

 Purchase of the Equipment
 Qualifying, installation validating
the Equipment
 Using the Equipment (operation, cleaning
and maintenance)
 Preventive maintenance and revalidation
 Replacing the Equipment
 Contd……

Why, how, level of technology, send to suppliers the factory acceptance test is done
Expected life, capacity prepared as at fabricators premises

equipment is received

SOPs are made qualification validation

SOP how to operate process like IQ,DQ PQ
For maintenance are
made

replaced by new better

advanced equipment
 WHO Guidelines for Equipments

 Equipments must be located, designed, adapted

and maintained to suit the operation to be carried out.
 Equipments should be installed in such a way as
to minimize any risk of error or of contamination.
 Production equipment should be designed , located,
and maintained to serve its intended purpose.
 Production equipment should be designed, so that it
can be easily and thoroughly cleaned on schedule basis.
 Production equipments should not present any hazard
to the products.
 Equipment Identification

WHO Guidelines:
Fixed pipe work should be clearly labeled to indicate
the contents and, where acceptable, the direction of
flow.

All service piping and devices should be adequately

marked and special attention paid to the provision of
non-interchangeable connections or adaptors for
dangerous gases and liquids.
 Equipment Cleaning & Maintenance

WHO Guidelines
The layout and design of the equipment must aim to
minimize the risk of errors and permit effective cleaning and
maintenance.

Washing and cleaning equipment should be chosen and used

so as not to be source of contamination.

Defective equipment should, if possible, be removed from

production and Q.C. or at least clearly labeled as defective.
 Filters
As a part of GMP, filters should be considered from
the following points-

1) Types of filter and filtration process

2) Compatibility of filter media with processing
materials
3) Cleaning of reusable filters and their
sanitation
4) Validation of filters
5) Disposal of filters
 Weighing Balance

WHO Guidelines
 Balances and measuring equipment of an
appropriate
other range and precision should be available for
production and control operation and should be
calibrated on a scheduled basis.
Weighing balance should be made
with following details

1. Description of balance
2. Model no.
3. Manufacturer name
4. Weighing range
5. Least count
6. Frequency of calibration
7. Location of balance
 Documents and formats to be maintained for every
equipment

Name and unique identification number of the

equipment

Equipment manufacturers, name and address.

Additional information on contact persons and their
mobile phone numbers may be useful

Equipments capacity in terms of holding and

output
 Contd….

Materials of construction of drug contact parts

Electric power requirement details

Utilities required to operate the equipment e.g.- water,

steam, compressed air etc
Indian Pharmaceuticals Ltd.
17
Machine History
Card
Modification
Sr.No. Date Time Nature of problem Time Sign
made/rectification made

Checked
From To Atte
by
 Indian Pharmaceuticals Ltd. List of
Equipment
18
Sr. Name of Capacity Date of Materials construction of contact
Make
No. equipment holding/output installation part made up of
 Indian Pharmaceuticals Ltd. Die Punch
Inspection Re19port

Sr. No. Tip size Body diameter Head Overall Working Cup
length depth
length
Reading Reading Go No go
1 2
 Indian Pharmaceuticals Ltd. Equipment/ Instrument
Services History Card
20

Details of repairs Service called Equipment Serviced

Sr. No. Remark
servicing/calibration on attended by
on
 Indian Pharmaceuticals Ltd.
Equipment Detail2s1 Card
Drive Details

Gear Box

Vacuum Pump

Air
Compression
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Vibrator

Coupling

Chain and
Sprockets