Storage and distribution loop

 

Storage tanks and distribution pipework systems are potential sources of contamination, particularly from bacteria. Good design and proper maintenance regimes are needed to minimise problems. The choice of materials of construction is also critical. Metals, other than stainless steel (316L / 1.4435 or 1.4404), should be avoided. There are many high purity plastics (PVDF) available but care needs to be taken to avoid those with fillers and additives which could contaminate the water. Storage tanks should be protected from ingress of contaminants with suitable vent filters. The purified water is recirculated continuously and cooled to maintain purity. UV disinfection is often used to maintain microbial purity in the distribution loop. Disinfection with Ozone is growing in popularity because it is generated in-situ and is twice as powerful an oxidant as chlorine.

Periodic sanitisation with heat is commonly used in pharmaceutical water installations. There are two main methods: hot water and over-heated water. Hot water sanitisation is the most straightforward method by heating up the water to 85°C/185°F and hold it during a validated period of time.

Dedicated to the design and operation of premium distribution systems

Key criterias for purified water (PW) & water for injection (WFI) loops

  • No stagnant conditions and areas of low flow rate
  • Temperature control, <25°C/77°F for purified water and >85°C/185°F for water for injection
  • Continuous and turbulent flow at all points in the distribution loop
  • Proper slope of the pipeline to ensure drainability
  • Stainless steel surface finish with appropriate roughness in order to avoid nutrient and biofilm accumulation
  • Air breaks
  • System fully drainable
  • No deadlegs according 6D rule (CFR 212)
  • Periodic sanitisation or sterilisation of the storage tank and loop
  • Storage tank protected with 0.2 micron hydrophobic vent filter
  • PW & WFI distribution designed as loop configuration
  • Sufficient instrumentation and monitoring equipments. Critical ones will be commissioned and qualified