Water system & Clean utilities

Water System in any pharmaceutical organization is of vital importance. Water is widely used in Pharmaceutical and related industry. Such as Potable water, Soft water and Purified water. Water used in process and in cleaning shall be pure and free from microbial and chemical impurities. GMP is specialized company for executing turnkey water system project.

 

Purified Water

In Pharma & Biopharma water is most widely used as a raw material or utility. Water used in manufacturing, cleaning of the equipments or in Process needs to be generated in pre-determined and validated process which includes.

  • Chlorination
  • Filtration
  • Softening
  • De-chlorination
  • Reverse Osmosis
  • De-ionization (EDI system)
  • Ultra-filtration etc
  • Distillation

At GMP we provide turnkey solution for water. From Raw water till the final purification GMP pay complete attention and design the system for ready to use. Our design is strictly comply regulatory requirements laid by different FDA guidelines, USFDA, WHO, UKMHRA, MCC and TGA etc.

 

Water for Injection

WFI is used for critical application and as name indicates it used in Injectable and related products. WFI is a key raw material for such products. WFI is also used in washing as final rinsing of the equipments etc. As per guidelines WFI is produced by Multi Column Distillation Plant (MCDP), water produced by such system should meet microbial norms of FDA.

 

Distribution systems (Water Loops)

Water produced from purification system shall be delivered at particular user point is a challenge. As the water gets easily contaminated by environmental condition, stagnancy etc, a continuous loop and recirculation shall be provided. At GMP we use critical instruments and design the system such a way that it never gets affected by environmental conditions. Thus maintaining the norms of chemical and microbial our design meets all the regulatory norms like conductivity, Endotoxin, TOC etc. All our systems are with 21 CFR part 11 compliance software and GAMP requirements.

 

CIP / SIP system

In Pharmaceuticals cleaning of equipments and process piping is very critical. Any residue of previous production batch shall wash away completely to avoid cross contamination. Thus cleaning is time consuming and more critical.
Our CIP and SIP skids are more efficient to take these challenges of cleaning. Our skids are completely with instrumentation and with atomization.

 

WHY CIP?

  • Superior Cleaning
  • Validated method for each product / soil
  • Lower operating cost
  • Safe – All the acids and alkalis are handled within the system.
  • Prevent wastages of water and cleaning agents and chemicals.

 

GMP provides all types of CIP system

  • Total Loss system
  • Single Re-circulation
  • Re-use (recovery)
  • Multi channel with different tanks system
  • Mobile CIP skids

 

Clean steam

Pure Steam is used in Pharma and Biotech for sterile application, for Autoclave sterilization etc. The condensate from Pure Steam shall meet the WFI water norms. Distribution piping of Clean Steam is a critical. We design the piping to avoid the wastage of Clean steam as clean steam is more costlier and critical. An improper sizing of pipes may lead to disturb the production process and loss of time during sterilization. We use of proper equipments and hygienic steam traps at appropriate places to avoid, any contamination and to deal with any impurities. Our distribution piping is as per ISPE guidelines and other regulatory norms.

 

Compressed air

Compressed air used in pharmaceutical shall be free from any impurities. At GMP we use proper filtration to avoid any air born particles travelling through the system. Proper filtration will be used at appropriate places to trap any foreign particles. We provide complete turnkey solution for compressed air system. Selection of accurate compressor, sizing and use as per application is GMP strength in providing the turnkey solution.

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