This document discusses the design, construction, identification, cleaning, and maintenance of equipment used in pharmaceutical manufacturing. It covers topics such as: - Designing equipment based on user requirements and material being processed. Size is determined by batch size and capacity needs. - Equipment must be properly identified with batch number and processing stage. Major equipment are numbered and recorded. - An equipment log tracks all operations, cleaning, and maintenance done on equipment along with batch numbers and personnel. - Cleaning and maintenance is important for preventing contamination and ensuring product quality. Standard operating procedures outline cleaning and maintenance procedures.

1. Presented by: Guided by:
MR. GOMTESH MILIND DOSHIMR. GOMTESH MILIND DOSHI Dr. S.S CHITLANGEDr. S.S CHITLANGE
M.Pharm.1st
year[QAT] Sem-1 Principal & Professor
Roll No. 526 Dr. D Y Patil IPSR,PIMPRI,PUNE
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2. CONTENT
1) DESIGN, SIZE AND CONSTRUCTION OF
EQUIPMENT
A) DESIGN
B) SIZE
C) LOCATION
D) CONSTRUCTION
2) EQUIPMENT IDENTIFICATION
3) EQUIPMENT LOG
4) CLEANING AND MAINTENANCE OF EQUIPMENT
5)AUTOMATIC AND ELECTRONIC EQUIPMENT
(computer system)
6) BIBLIOGRAPHY
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3. INTRODUCTION
i) EQUIPMENT: Pieces of plant, machine, instrument to do
specific activity e.g. mixer, grinder, granulator
ii) EQUIPMENT: may be single piece or set of integrated
pieces to perform common activity e.g. water
demineralization plant
iii) Performance of equipment: affects manufacturing or control
activity
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4. DESIGN, SIZE, LOCATION AND
CONSTRUCTION OF MATERIAL
1)DESIGN:
 URS: User tells his requirement based on this URS (User
Requirement Specification is made) for equipment is made
 what operation equipment will perform
 Capacity: In put (holding) and output capacity
 Material (API etc.) will be processed
 Cleaning method is Used
 Validation how to do validation
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5. 2. SIZE:
Batch size / vol. of material decides size
i) Physical dimension: L x W x H of equipment, size of
room, avoid difficulties in taking in to room, new wall
construction
ii) Holding and output capacity, Minimum or maximum
volume of material decides size
Autoclave for small
scale
Autoclave for large scale
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6. 3. LOCATION:
i) Based on equipment layout, mix up, contamination
ii) Utility services required to equipment
iii) Easy material handling & movement
iv) Man movement for repair and cleaning.
v) Equipment discharge gas, powder fumes
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7. 4. CONSTRUCTION:
(Material of Construction – MOC)
i) Easy of cleaning
ii) Easy of operational
iii) Easy of maintenance
iv) Contamination: MOC does not react with material (API)
MOC does not absorb material (API)
Document required:
1) Machine/equipment/layout drawing showing the
location in room
2) Machine equipment manual 7

8. Preparation of URS Of Equipment
URS: List of all requirements of buyer regarding the
equipment to be purchased.
•Use of equipment in mfg
•Required capacity of equipment
•Space availability for installation
•Accuracy of equipment
•Cleaning requirement
•Power supply
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9. EQUIPMENT IDENTIFICATION
As per US FDA guidelines CFR 211.05:
a) All compounding and storage containers, processing lines and
major equipments used during production of batch of a drug
product shall be properly identified at all times to indicate their
contents and when necessary the phase of processing of the
batch.
The label shall be following detail:
 Name of product
 Batch No.
 Batch Size
 Processing stage
 Supervisor
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10. b) Major equipment identified by a distinctive
identification number or code that shall be recorded in
the Batch Production record to show the specific
equipment used in manufacturing of each batch.
Documents Required:
 SOP for numbering of equipment
 List of major equipment with their distinctive
identification number or code
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11. EQUIPMENT LOG
1) Equipment Log or Register: Each manufacture maintains a
log or register. Log mentions the name of various operation
(operation, cleaning or maintenance) done on various
equipments
2) Content / Details in Log: Following details are mentioned in
log.
 Sr. No.
 Name of equipment (with identification number, code)
 Product Batch no. handled
 Name of activity / operation (operation, cleaning or maintain
and with date
 Name operator and supervisor working on equipment
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12. Documents Required:
 Equipment Log: for activities e.g. operation, cleaning
and maintenance
 SOP for major equipment of operation, cleaning,
maintenance
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13. CLEANING AND MAINTENANCE OF EQUIPMENT
1) Need cleaning, Maintenance And Sanitation:
Prevents malfunction of equipment, cross contamination,
and achieve identification, purity, strength and safety of
product.
2) When cleaning required:
 Change over from one batch to another
 Change over from one product to another
 Change over from potent to non potent
 Change over from non potent to potent
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14. 3) Water washing sample:
Water washing sample is analyzed to check
acceptable level of cleanliness.
4) Duration of cleaning:
Equipment should be cleaned after use, checked
before use, after specific interval of time rewashing is
to be done.
Documents Required:
 SOP for maintenance and cleaning of equipment
 Equipment log for operation, cleaning and
maintenance.
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15. Department: Month:
Equipment: Make:
Equipment code no.: Working capacity:
Cleaning SOP no.: Maintenance SOP no:
Date Sign Remark Date Sign Remark
Cleaning Maintenance
Equipment Cleaning and Maintenance Record
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16. Introduction / Computer System
i) Automatic, mechanical and electronic equipments or computer
systems is used in R&D, QCL, QA and Production
ii)It is mandatory that performance of computer system is
confirmed that results are consistent, accurate and repeatable
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17. Why is computer validation required?
1) Minimize Risk to Patient life and increase product quality
and Good will
2)Business Opportunity: Validated computer system is
Required to export in Australia, Europe, USA and South
Africa
3) Helps in perfecting the system and make free from any
errors
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18. BIBLIOGRAPHY
1) M.A.Potdar Pharmaceutical quality assurance ,Nirali
publication.3 rd
, 1-14
2) www.pharmaguideline.com
WHO ,Geneva-1999
3)Quality assurance of pharmaceutical guideline material
Vol-ll,
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19. THANK YOU
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