Validation

Compressed Air Validation

Ensure the safety and reliability of your compressed air systems with our comprehensive validation services. Our expert team conducts thorough testing, documentation, and analysis to ensure compliance with regulatory standards. We assess critical parameters such as air quality, pressure, and flow to identify any potential risks or inefficiencies. With our validation services, you can have confidence in the performance and integrity of your compressed air systems, ensuring optimal operation and peace of mind. Trust us to deliver accurate and reliable results that meet the highest industry standards.

SERVICES
Calibration Services
HVAC Validation Services
Compressed Air Validation Services
Temperature Mapping
AMC & Instrument Sales And Service

Our services

Compressed Air Validation

The Compressed air that comes in direct contact with Pharmaceutical Products is vital to assuring the Quality and safety of those products as per ISO 8573-1, EP, BP, and USP the following parameters need to be performed once in a year.

Compressed Air Test Parameters

  • Appearance
  • Solubility
  • Oil mist
  • Identification
  • Dew Point
  • Microbial counts
  • Hydrocarbons
  • Sulfur Dioxide
  • NO2
  • Moisture content
  • Carbon Dioxide Concentration
  • Carbon monoxide concentration
  • Dust Particles monitoring [NVPC]
  • Suspended Particulate Matter
  • Oxygen Content

Nitrogen

Nitrogen Gas is a Critical Component in the Production of Pharmaceutical Industry and effects on the Quality of the end Product. Therefore, it should be monitored and ensure that the desired quality of the nitrogen air is used in Production and need to be monitored once in a year as per ISO 8573-1, EP, BP, and USP the following parameters need to be performed once in a year.

  • Nitrogen Test Parameters
  • Description / Characters
  • Identification
  • Oxygen Content
  • Moisture content
  • Microbial counts
  • Oil mist
  • NO+NO2
  • Solubility
  • Dew Point
  • Sulfur Dioxide
  • Suspended Particulate Matter
  • Nitrogen Purity Test by GC
  • Dust Particles monitoring [NVPC]
  • Carbon Dioxide Concentration

Breathing Air

Breathing Air Validation – The Quality of Breathing air is important to ensure that the respiration System will function properly and reliable, Clean Natural Air is an odorless, colorless Gas mixture, Air contains three major elements makeup about 99.97% of Dry Air: Nitrogen [N2] at 78.09%, Oxygen [O2] at 20.95%, Argon [AR] at 0.93% an important minor component of Natural air is Carbon Dioxide [CO2] at 0.03% [300ppm].

Breathing Air Test Parameters

  • NO+NO2
  • Sulfur Dioxide
  • Oxyge Content
  • CO2 Concentration
  • CO concentration

Pure Steam Quality Testing

Steam Quality test to Qualify Plant / Utility / Clean / Pure steam generators, Steam Distribution systems and steam supplies to Autoclaves in accordance with cGMP, HTM2010, EN285, DIN 58950, ISO 14937:2000, ASTM ST79, ISPE Baseline guide for steam and water and PDA Technical Report No.1 & 48.

Steam Quality Test Parameters

  • Non condensable gases [Inert gases]
  • Dryness Value
  • Super heat Testing

Filter Integrity Test For Gas Filters [Compressed Air & Nitrogen]

Hydrophobic sterilizing grade Gas cartridge Filters shall be used for gases filtration, like Compressed Air, Nitrogen and Other Process gasses which directly contacts with Pharmaceutical Products that are vital to assuring the Quality and safety of those products as per PDA Technical report 6 the following parameters need to be perform once in six months or a year / as per the Requirement

Filter Integrity Test Methods

Water Intrusion Test

Is widely utilized in Bio /Pharmaceutical Manufacturing and Research Laboratories to perform inline integrity testing of Sterilizing grade gas filters with hydrophobic membranes. The Palltronic Flow star IV Instrument is specially designed and validated to perform this very sensitive test.

Bubble Point

The Palltronic Flow star IV integrity test instrument can determine the Bubble Point of a filter. The gas flow rate is measured at increasing pressure steps, and the Bubble Point is the transition of diffusive gas flow through wetted filter pores to bulk gas flow through de-wetted filter pores.

Forward flow Test

The Forward flow is the Filter Integrity test that is most common in Bio / Pharmaceutical manufacturing. All major filters supplier recommended the forward flow test as the method of choice for integrity testing of filter cartridge or capsule assemblies. The Palltronic Flow star IV instrument performs the forward flow test quickly and with extreme accuracy. The volume dosed flow meter can perform a forward flow test in a range of 0.1 to 1000 mL / min within minutes and with an accuracy of 0.1 mL / min or 3%.