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Equipment Design and Maintenance - Coggle Diagram
Equipment Design and Maintenance
Key Principles
Right Equipment
appropriate design & size
more working and in-process storage space
Minimise
mix-up/ cross-contamination
Risk of omission, wrong application of manufacturing steps
Allow orderly & logical positioning of equipment & materials
Easy to clean & maintain
Contact surface must not be
Reactive
Additive
Absorptive
Substances
Example
Oil
Lubricants
coolant
No direct contact with in-process materials or products
prevent alteration to safety, purity, strength of drug product
Non-fibre releasing
example (filters)
for liquid filtration
Location
Right facilities for the intended use
Example
Mixing equipment in clean room
diff room req for diff activities
Labelling equipment in packaging room
Particle generating operations to be out of production
Cleaning and maintenance
Routinely cleaned, maintained and calibrated
Prevents
Malfunctions
Contaminations
prevent alteration to safety, purity and strength of drug product
Design and Construction
Material of construction
Chemically inert
Resistant to corrosion
Example
Stainless steel grade 316L
Fluoroplastics
polyvinylidene fluoride (PVDF)
perfluoro alkoxyalkene (PFA)
Surface finishing
requirements
Smooth surface
Facilitate cleaning
if rough surface
increased surface area for bacteria
Ease of cleaning
Minimise microbial growth
example
316L Stainless Steel
Inner surface roughness
0.4 um
direct contact require more smoothness
Outer surface roughness
0.8 um
Dead leg
a spot with no fluid circulation
increase proliferation of microorganism & biofilm production
Additional notes
increasing turbulence decreases criticality of dead legs
If dead leg is drainable, criticality decreases
periodic cleaning + sanitisation decreases risk of contamination
long process time in pipe, increases risk of contamination
Using valves without pockets, decreases dead legs
Design considerations
Pipelines
inclined slightly downwards
Allow drainability
Water distribution loops
angled downwards
Pumps
All fluid contact material must be FDA compliant
example
seats, ball, diaphragms are food grade elastomers
Valves
body
made of SS316L
Diaphragms
silicone, PTFE
Location
Equipment must be located in the right facility
Supporting equipment
Out of production area
Properly encased
Identification
Equipment:
Identification number
Serial number
Dimensions
Capacity
Location
Purpose
Pipeworks:
Content
Flow direction
Cleaning and Maintenance
Clean and maintain regularly
Written procedures
Records
Cleaning procedure
Schedule
Methods of cleaning
Protection of clean equipment
Inspection before use
Equipment label for status of equipment
eg. Labels indicating 'cleaned' or 'sanitized'
Cleaning methods
Manual
Auto-cleaning systems
Clean-In-Place (CIP)
Typical operation
1) Pre-rinse with water
2) Caustic (alkaline detergent) solution wash
- remove fats, oils and greases
3) Rinse with water
4) Acid wash
- scale remover and pH satbilization
5) Final rinse
6) Dry using air heaters/fans
Sterilize-In-Place (SIP)
Designed for automatic cleaning and disinfecting without major disassembly
Preventive maintenance
Routine calibration of measuring instruments and equipment
Defective equipment removed/labelled
Records
Calibration records
Maintenance records
Cleaning and sanitization records
Change control
Equipment modification
Equipment replacement
Equipment relocation
Process modification
Material change
Identifies changes
Evaluates the impact
Re-qualifies when necessary
Ensures consistent quality