Calitech Providing services for the following Parameters at its state of the art Laboratory which is equipped with Reference Calibration Standards.
The major calibration services that we provide are mention below
Calitech provides validation of Sterilization Equipments like Autoclave, Dry Heat Sterilizer and De-pyrogenation Tunnel.
Our Reports & Protocols are Developed as per guidelines of FDA, WHO, MHRA & all the software we use for validation are compiling to 21 CFR part 11.
Validation Protocol Includes Procedure/Pass Criteria/Lethality & Fzero and Fh Calculations, Graphical representation/ Min.& Max for each point Temperatrue, Hot & Cold Spot, Conclusion and result.
Our reports includes Graphical Representation, Lethality and F value calculation and Summary Reports.
The Reporting formats consist of Diagram Indicating Sensor Locations, Mini. & Max. Temperature at all locations, Graphical Representation of Temperature Vs Time, Hot & Cold spot, Standard Deviation and Mean Kinetic Temperature (MKT).
Test Includes,
HVAC Validation perform as per ISO 14664, EU cGMP, US Federal Standard 209E, USFDA Body WHO Geneva, USFDA, TGA (Australia), European standards (EMEA), MHRA, (European Countries) guidelines for all room classifications.
Test Includes,
Capture Hood
Particle Counter
TSI Anemometer
2i AT Iphotometer
With latest equipments for steam quality test, for testing quality of pure steam at user point like Autoclave, Sterilizers, Manufacturing tanks, SIP, Lyophilizer, PSG etc. It is Regulatory requirement to test the quality of steam periodically. We undertake the job and provide reports which compiles to EN 285 /HTM 2010 Guidelines for Sterilizer Validation.
Test Includes,
Compressed Air Validation, a very essential confiendence requirement for using the compressed air in production areas, we have latest set of equipment to carry test as per ISO 8573 guidelines. It is Regulatory requirement to test the quality of steam periodically.
Test Includes,
All computer systems and software impacting on product quality must be identified, and the risks in their use evaluated. From large-scale process control through to simple embedded code in a regulated device, pharmaceutical and medical device manufacturers are required to validate GxP-critical systems.
Validation can increase the usability and reliability of the system, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to customers and users.
We ensure that your computer systems are compliant with GAMP 5,FDA, GxP, 21 CFR Part 11,EU Annex 11,organizational quality system (GLP, GMP, and GCP) Other Governmental regulations and industry standards.
We undertake TURNKEY projects including AIR CONDITIONING, CLEAN ROOM PANELS , FIRE FIGHTING, PLUMBING, ELECTRICAL FOR PHARMACEUTICAL, API, HOSPITALS & MALLS.
Calitech Technical Services LLC offer modular clean room partitions, Clean room equipments, HVAC high side equipments such as chillers/ DX units, pumps and piping network and HVAC low side equipments such as air handling units (AHU), Ducting, Duct insulation, Filter Modules, Filters, Grills, Diffusers, Dampers and AHU manifolds. We develop DQ, IQ, OQ documents and validate the facility as per cGMP protocols.
Double Skin Air Handling Units are one of the most versatile and premium products in HVAC. Now, Air Handling Units play an important role in overall performance of HVAC system. In view of all theoretical & practical problems, Calitech has developed double skin units suitable for multiple applications. Self-supporting extruded aluminum framework with injected PUF insulated panels provides strength & rigidity. Pre-coated / Powder-coated AHUs are attractive & unique.
Making use of latest technologies, our organization is involved in manufacturing a wide array of Condenser Coils. Under this category, we offer a wide assortment of Evaporator Coil, Hot Water Coils, Chilled Water Coils, Steam Distributing coils BOD Incubator / Hot Air Oven / Muffle Furnace / Stability Chamber.
Manufacture & Exporters of Wide Range of Return Air Riser Made out of 18/20 Swg. CRCA / Galvanize Powder Coated / Stainless Steel 304 Construction for Suitable of Wall Mounted Top / Side Connection With Arrangement of Manually Operated Volume Control Damper , Aluminum Powder Coated / SS 304 Capsule Perforated Grill & 20u HDPE Washable Cassate Type Pre Filter.
We are Supply of Ceiling Suspension Galvanized /CRCA Sheet Powder Coated Construction Laminar Air Flow Housing with Low leakages G.I. Gear operated Volume Control Damper, Side Connection, PAO Testing arrangement, Pressure Plate to fixing of filter , Internal arrangement for fixing of HEPA Filter & SS Capsule Perforated Supply Air Grill.
Air filters – pre-filters, micro-vee & HEPA filters :-
Pre-filters are built into 18 Gauge Aluminium / 20 Gauge CRCA Powder coated / GI Construction. The filter can be easily washed or soaked in addition with detergent and then gently given and air pressure to dry it in the atmosphere. The Pre-filters are randomly tested as per ASHRAE 52.1 Synthetic Dust Load Efficiency test with Air Velocities and Static Pressure drops are measured on the TESTING RIG constructed as per Standards.
Micro- Vee filters are built into 18 Gauge Aluminium / 20 Gauge CRCA Powder coated / GI Construction. The filter can be easily washed or soaked in addition with detergent and then gently given and air pressure to dry it in the atmosphere. The Pre-filters are randomly tested as per ASHRAE 52.1 Synthetic Dust Load Efficiency test with Air Velocities and Static Pressure drops are measured on the TESTING RIG constructed as per Standards.
High Efficiency Particulate Air Filters are the most efficient air filters commercially available. Hepa Filters are built into 16 gauge Aluminium / SS construction are some times known as absolute filters, essentially dry arrestennce filters with exceptionally high efficiency 99.97% down to 0.3 microns. Hepa Filters are generally tested by Integrity Test by a Photometer. We use a glassfibre paper media (generally 125-130 pleats) in a normal filter of 2 ft. length, separated by piece of corrugated material generally used Aluminium to keep resistance & media velocity. The filter pack & separators are sealed with fire retardant solution when dry hardened providing positive seal for leakage.
Clean rooms are unique in their construction, having virtually every component built in during production to suit all applications and to meet industrial requirements.
Calitech offers a complete range of clean room partition and ceiling systems. These systems meet the technical requirements of high specification controlled environments such as Pharmaceutical, Biotech and Microelectronics, as well as Food-processing plants. The ceiling panels are non-particle shedding, load bearing, walkable panels and feature pre-formed cut outs for the housing of HEPA filters and other dedicated services.
We Develop, Manufacture, Supply and Install complete Clean Room Modular Flush Sandwich Panels / Partitions.Our Panels are manufactured with Galavanized Steel Sheet (G.I.) for the wall skin and high quality of exclusive material Aluminium Profiles for Top & Bottom tracks and Vertical sides of panels for better flexibility & durability.
We Develop, Manufacture, Supply and Install complete Clean Room Modular Flush Sandwich Panels / Partitions.Our Panels are manufactured with Galavanized Steel Sheet (G.I.) for the wall skin and high quality of exclusive material Aluminium Profiles for Top & Bottom tracks and Vertical sides of panels for better flexibility & durability.
We offer a complete range of Flush Doors with Vision Panels designed to integrate into wall systems like Sandwhich Panels / Partition and Masonary wall for Clean Room Application.These are Scientific Doors specialy for Clean Room Applications.
Calitech supply Static and Dynamic pass boxes meeting the customer specific requirements and to the highest standards. Passbox is designed to allow material transfer without much personnel movement. It also aids controlling ingress of particulate contaminants into clean rooms & between different classified areas.
Calitech supply Vertical and horizontal laminar air flow for offering highest product protection for samples and processes by providing ISO Class 5 particle free work area. The laminarity of the flow prevents cross contamination between the items handled in the working space.
Bio-safety cabinets are designed to provide personnel, environmental and product protection. Air flow is drawn around the operator into the front grille of the cabinet which provides personnel protection. Additionally, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination along the work surface of the cabinet.
We provide patrons with the superior quality of Dispensing Booth. Appreciated for its compact design, easy installation and high performance, the dispensing booth is fabricated by using latest machinery, Used for filling, refilling, weighing and sampling, the laboratory dispensing booth is used in various scientific laboratories.
Features :-
Calitech technical Services providing a broad spectrum of Epoxy Self Leveling Service, Flooring Service, Coating Service, Internal and External Wall Painting Service, Yellow Marking Walkway Epoxy Painting Service, Epoxy Chemicals and many more. This particular self-leveling Epoxy Flooring service is viewed as perfect for giving dust evidence, clean and cleanliness surface to the floor. In that capacity, the reach is exceptionally utilized as a part of various pharmaceutical units, operation theaters and nourishment industrial facilities.
© 2017, Calitech. All Rights Reserved./Designed By : Softyoug Solutions