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In Utilities - Coggle Diagram
In Utilities
Water
Chilled waters
- produced by chiller (remove hat from liquid via vapor-compression)
- for cooling & dehumidifying air
Cooling waters
- produced by cooling water
- for heat exchanger, reactor jacket
Softened waters
- generated by ion exchange
- mineral content (hardness) removed/reduce
- constituted by calcium & Mg ions
Purified water (PW)
- high quality water
- meet chemical & microbial requirement
- pharm application
- raw material: production of non-parenteral drug products
- cleaning: process equipment
Requirements
- microbial limit (less than 100 CFU/ml)
Production
- reverse osmosis (RO)
- deionization(DI)
- ion exchange
- ultrafiltration (UF)
- distillation
-
Process Gas
Compressed Gas
Non-liquefied Gases
- bpt below -90C (O2, N2, Argon)
Liquefied Gases
- bpt near atm temps (-90 to 20C) like CO2
- liquid form in storage containers at ambient temp & Pa from 25 to 2500psig
Compressed Air (CA)
- O2 & N2 mixture
- classified into:
- breathing air - supplied to operators working in PPE in hazardous/dusty area
- instrument air - actuation of pneumatic controllers (eg. valves, transmitters)
- process air - process that don't require sterile air
- sterile air - aerobic fermentation, cell culture, breaking vacuum/cooling vessels after steam sterilization
Nitrogen (N2)
- diatomic, chemically inert gas, bpt: -196C
- Blanketing gas
- gas layer in headspace of product containers
- minimise risk of fire & dust explosion
- prevent undesired reactions with atm O2
- Cryogenic liquid
Steam
Plant Steam
- produced by boiler
- lower purity
- non-product contact process heating:
- heat exchanger, autoclave jacket
- drinking water as feedwater
- contain chemical dditived to control scale & corrosio
- produced using fire-tube steam boiler, fed by oil & gas
Pure (Clean) steam
- produced by distillation
- higher purity
- free from volatile additives (eg. amines) & entrained water droplets
- steam/condensate come in contact with product directly/indirectly
- parts sterilization, cleanrooms humidification
Requirement
- Chemical & microbial attributes
- condensate same as WFI (USP)
- Critical attributes
- steam for sterilization in autoclave
Generation
- purified/higher grade water as feedwater
- cause absence of volatile additives
- types of clean steam generators: reboiler, falling film
Water Sampling
Water Quality Monitoring
- for cleaning/initial rinsing (PW)
- for manufacturing/final rinsing
Tested regularly for
- Total Organic Carbon (TOC)
- conductivity
- endotoxin
- microbial count
Clean Utilities
- have direct impact on product quality
- must be validated