Clean Room Validation :

Clean room is one in which sterilized drug product containment & closure are exposed to environmental conditions designed to maintain product sterility and aseptic conditions. Clean room applications include testing of contaminants, cross contaminants, particulate count, cleanliness class, verification of cleanliness, air pressure differential, air changerate and verification unidirectional flow or containment conditions.

 
We undertake specific tests based on:
  • Quality Assurance of pharmaceuticals as a compendium of guidelines.
  • Good Engineering Practice, Good Manufacturing Practice in Pharmacy.
  • Medical Products, Space Applications.
  • ASHRAE standards ISPE baseline Pharmacy Engineering Guidelines.
  • International Clean Room Standards based on ISO:14644-1.
  • W.H.O.
 
We offer following Validation Services :
 
  1. HEPA filter Integrity
  2. Particle Count
  3. Velocity Measurement & No. of Air Changes
  4. Differential Pressure in the facility
  5. Temperature & RH
 

Salient Features of our Services:

 
  • System validation will be done by latest state of the art calibrated equipment for the above services
  • Sampling Rate of 1 CFM in case of HEPA Filter & Particle count.
  • Equipment has 6 size channels – Thresholds set at 0.3, 0.5, 1.0, 5.0, 10.0 & 25.0µm.
  • Validation for Particle Count is done with the equipment which has built in Clean Room Standards (FS209E, ISO14644-1, BS5295)
  • Undisturbed operation in Clean room as the equipment can be controlled from Office thro' Ethernet Connectivity.
  • Hotwire Anemometer for measuring Air Velocity.
  • Accurate reports with required inputs on corrective actions.
 
HVAC Projects Design and Execution:

 

A. Preliminary Design, Engineering and Planning
 
  • Receive set of Architectural drawings.
  • Discuss and collect basic engineering data from us.
  • Visit site and inspect the facilities available.
  • Study and review heat loads of various areas and evolve design and configuration of the HVAC system.
  • Submit design basis report with HVAC conceived togather with budgetary cost estimate and Utilities consumption's such as fuel, electricity and water for our approval.
  • Review existing sizing and selection.
 
B. Detailed Design Stage
 
  • Preparation of preliminary designs for our/Architects approval for comments, if any by way of drawings and adequate to explain the general planning and nature of works with basic dimensions inclusive of duct and shafts/Slab punches and such other features required for services obtaining the approval from us/Architect.
  • Preparation of working drawings and detailed specifications for all the required modifications aspects of the work and furnishing details required for execution of work and making available for scrutiny the detailed design calculations and obtaining the approval from us/Architect for the same.
  • Prepare engineering layout drawings for tender purpose such as below:
  • Main plant room layout/or package units room layout (With propose modification)
  • AHU room and layout/ FCU layouts
  • Schematic Condenser water piping layout (With propose modification)
  • Schematic chilled water piping layout
  • Typical piping/ducting support details.
  • P & I diagram (With propose modification)
  • Piping sizing and header(With propose modification)
  • detailed Duct layouts of Various areas with section details (With propose modification)
 
C. Execution Stage
 
  • Scrutinize and approve working details design layouts and drawings submitted by contractors
  • Visit site periodically for technical discussion and advice/assist your project in charge.
  • Advice/Assist your project in charge during final testing/commissioning and performance of the plant.
  • Co-ordinate with contractors that all HVAC, installations are done as per good engineering practices.
  • Co-ordinate with contractors for Commissioning and performance testing.
 
Pre insulated Ducting
 
We are the solution provider for pre insulated ducting which involves supply of material fabrication of ducts and installion work. We import poly earathane (puf) panels from Pal Middle East and are their distributors for gujarat.
 
Advantages of Pre insulated Ducting
 
  • Cleanable and hygienic
  • Environmentally Friendly, CFC, HCFC Free
  • Clean Air, Contains no microfibers
  • Environmentally Friendly, CFC, HCFC free
  • Resistance to fungus growth
  • Space Saving: Flush fitting installation possible
  • Low Leakage: Fully Sealed system conforms to DW 144 Class C-high pressure
  • Low "U" value
  • Energy Savings: Up to 20% annually
  • Fast-Track Installation: Rapid erection combined with single fix installation
  • Site fabrication capability
  • No limits to duct sizes
  • Self Supporting
  • high-Compressive strength
  • High rigidity/ integrity, Self supporting ducts
  • Base material is impermeable to moisture, insoluble
 
Precision Air Conditioning
 
System installation for server room, Data centres where high sensible heat load in involved and high cfm machines are required for such areas. We deal in Uniflair's pression acs.
 
Uniflair's precision air-conditioning products are equipped with unique intelligent fetures offering maximum reliability, efficiency, precision and due respect for the environment. no wonder then some of the most respected companies across 5 continents and 60 countries rely on Uniflair's precision air conditioning solutions to power their mission critical business.
305, Grand Monarch, Nr. Seema Hall,
100 Ft. Road, Satellite , Ahmedabad–380015 .