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Pharma

A. Utility Assessment:

Redundancy and Energy Performance of utilities is critical in successfully operating a central utility system with minimal down time and energy footprint. This is achieved by assessing the exiting installed capacity and operational consumption of all utility systems to identify gaps and assist in corporate energy planning.

Our utility assessment services involves

  • Study of classified area URS to confirm that humidity, temperature, ACPH and pressure requirements are correctly specified as per applicable cGMP and regulatory requirements.
  • Analysis of HVAC system and providing solutions to fill in gaps identified in regulatory compliance and performance.
  • We also map utility consumption using data loggers to identify maximum and minimum utility demand and utility consumption which is used to develop optimum equipment loading and capital investment plans.

Benefits

  • Ensuring cGMP and regulatory requirements are met for HVAC systems and clean utilities.
  • Provide solutions to close cGMP and regulatory gaps.
  • Provide solutions for performance gaps in clean and general utility systems.
  • Obtain actual maximum and minimum utility demand and utility consumption.

Industries served

  • API Manufacturing facilities
  • Finished Dosage form manufacturing facilities
    • Oral Solid Dosages
    • Liquids
    • Tablets and Soft Gelatin Capsule
    • Aseptic products

B. Utility Integrationt:

Pharmaceutical facilities experience a challenge that most of the utilities operate on part load, but cannot be combined to supply to multiple blocks. Air Handling Units (AHU’s) are found to have chilled water flow rates much higher than that required as per cooling requirement. These adversely affect equipment availability and operating efficiencies. Such a situation increases risk of equipment failure as well as excess energy footprint. Integration of utilities with proper control strategy ensures satisfactory levels of redundancy and optimal system performance.

Our integration techniques help use utility equipments for multiple blocks creating redundancy from available machines and reduce energy consumption.

Our Integration Services include

  • Mapping of plant demand, present as well as future, to identify average and peak.
  • System Architecture and Integration Design
  • Control Strategy and Data Analytics
  • Execution and installation phase

Benefits

  • Energy efficient control strategies
  • Improved redundancy
  • Lower energy foot print
  • Measured demand (maximum and minimum) of utility system.

Industries served

  • API Manufacturing facilities
  • Finished Dosage form manufacturing facilities
    • Oral Solid Dosages
    • Liquids
    • Tablets and Soft Gelatin Capsule
    • Aseptic products

C. Clean Utility Assessment:

In pharmaceutical facilities delivering uninterrupted supply of clean utilities is essential to reduce downtime and eliminate associated product loss. Redundancy in clean utilities such as pure water, water for injection and pure steam systems is critical. Clean utility systems are some of the largest consumers of plant utilities. However efficiency of clean utility systems are seldom measured or assessed.

Our clean utility assessment services involves

  • Study of pure water, WFI and pure steam generation system if specified as per applicable cGMP and regulatory requirements.
  • Mapping utility consumption using data loggers to identify maximum and minimum utility demand and utility consumption which is used to develop optimum equipment sizing/loading and capital investment plans.

Benefits

  • Ensuring cGMP and regulatory requirements are met for clean utility systems.
  • Provide solutions for cGMP and regulatory gaps identified.
  • Provide solutions to bridge performance gaps in clean utility systems.
  • Obtain actual maximum and minimum utility demand and utility consumption.

Industries served

  • Finished Dosage form manufacturing facilities
    • Oral Solid Dosages
    • Liquids
    • Aseptic products

D. cGMP compliance of cleanroom HVAC systems:

Cleanroom HVAC systems monitor and control the temperature, humidity, particle count and air change rates in Pharmaceutical Cleanrooms. By design, Pharmaceutical AHUs have very high circulating air flow rates compared to required dehumidified air flow rates resulting in reheat and simultaneous consumption of heating and cooling. Assessment and improvement of AHU systems helps in identifying unnecessary simultaneous heating and cooling.

Our Cleanroom HVAC services includes

  • Measurement of AHU system to identify cGMP, regulatory and performance gaps.
  • Measure and Identify unnecessary simultaneous heating and cooling.

Benefits

  • Ensuring cGMP and regulatory requirements are met for AHU systems.
  • Provide solutions to bridge performance gaps in clean utility systems.
  • Latent free solutions reduce reheat up to 70% and provide optimal temperature and humidity control.

Industries served

  • Finished Dosage form manufacturing facilities
    • Oral Solid Dosages
    • Liquids
    • Tablets and Soft Gelatin Capsule
    • Aseptic products