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CALITECH

GIDC Char Rasta, Vapi, Valsad, Gujarat

| GST  24AKZPP2155Q1Z7

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We are Leading Service Provider in Field of Calibration, Validation and HVAC validation Service , Providing service to reputed companies like Dr. Reddy's, Ranbaxy, Zydus, Ipca etc. We are successfully Audited by NABL. We provide certificate which complies ISO/WHO/MHRA/MCC/TGA/USFDA requirements. We also provide consultancy to design protocols and methods. Our services are speard all over india like Jammu, Himachal Pradesh, Uttranchal, Kolkatta,Ahmedabad, Indore,Goa,Hyderabad,Banglore etc. Having 04 branches in Ahmedabad, Kandla, Baddi and Dehradun. We have also latest technology for Steam Quality Test and Compressed Air Validation as per WHO requirement Regards, Premal Patel CEO+ Read More

Nature of Business

Service Provider

Total Number of Employees

11 to 25 People

Year of Establishment

2004

Legal Status of Firm

Individual - Proprietor

Annual Turnover

Rs. 2 - 5 Crore

GST Number

24AKZPP2155Q1Z7

Compressed Air Validation Services
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He demand for compressed air quality depends on its usage. In some industries extremely high quality air is of utmost importance. We have the tools to validate compressed air in accordance to iso8573 with respect to: dewpoint, oil carryover, moisture content, particulate burden.

we can also assess the air for trace gases (including carbon dioxide/monoxide) with the use of industry standard draeger tubes. For very high quality (class 1 or greater) we have connections with analytical laboratories that can analyse out filter papers for hydrocarbon and viable burdens. We have considerable experience working in pharmaceutical gmp areas providing validation of systems during iq, oq and pq validation stages. Out validation work is not limited to compressed air however; we can easily test in other inert gases using the same equipment and techniques.

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Calibration Service
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Calibration Service

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Calitech calibration facilities meets stringent requirements of International Standard ISO/IEC:17025. Calibration, which is a process of comparison, is therefore associated with a level of uncertainty. Our reports completely indicate the uncertainty associated with measurements.

“Calitech” is equipped with sophisticated Calibration equipment. The Calibration Accuracy of these Master Standards are traceable to National & International Standards. Facility includes Computerized Automatic Calibration & Report generation conforming to ISO Standards.

High accuracy calibration equipments, trained personnel & strict environmental conditions shows the strength of the “Calitech Calibration Laboratory” to meet the customer requirement and to provide service at its best.

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Product Validation Services
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  • Where environmental conditions, such as temperature, humidity, particle content and biological contamination are important aspects of pharmaceutical, biotechnical and or medical device production, validation and qualification of the HVAC system must be performed.
  • This validation must utilize a risk-based approach, which involves a high level of process understanding and focuses on potential problems, risks, and all suitable countermeasures. The validation must verify that in all areas where drugs or raw materials have air contact, the air cannot adversely affect the quality or efficacy of the product.
  • To fulfil regulatory requirements, a clean room HVAC system must maintain environmental condition within specified specifications. These conditions must be regularly monitored to ensure constant awareness of environmental conditions, such as temperature, humidity, pressure and particle levels. Digital outputs for alarms must also be monitored to ensure that an alarm will be raised if there is a change in any of the designated parameters.
  • All such environmentally controlled areas, zones and or rooms must be included in a preventative maintenance and calibration program that will monitor all trends and ensure continued use within the User Requirements specified specifications.

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Thermal Validation
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Thermal Validation

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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 & 21 CFR.

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.

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Temperature Mapping
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Temperature Mapping

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On Demand of our pharmaceutical Clients we have developed facility for temperature mapping of warehouses and clean-rooms.

Our Reports & Protocols are Developed as per guidelines of FDA, WHO, MHRA & 21 CFR.

Our Report Complies To WHO/MHRA/US FDA /TGA/MCC Requirements.

Our reports includes Graphical Representation, Lethality and F value calculation and Summary Reports.

We Provide Temperature Mapping Report with Mean Kinetic Temperature (MKT)

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Steam Quality Test
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Steam Quality Test

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From 1st October 2008 all member states of CEN (European Committee for Standardisation) who use steam in any moist heat sterilization application will be required to test the steam for non-condensable gases, superheat and dryness value.

Documentary evidence that the sterilizer complies with the requirements of the European standard will need to be established, maintained and declared.
The steam supply required for moist heat sterilization needs to be within the specifications set out in EN285:2006. This is:
Non-Condensable Gases: Required Result = 3.5%
Air and other gases such as Carbon Dioxide, which do not condense under the conditions of steam sterilization.
Superheat: Required Result = 25ºC
Superheat steam is a steam at a temperature which is greater than its boiling point for its pressure. It will not condense until its temperature drops to its boiling point and until this occurs the moisture required for sterilization cannot be produced.
Dryness Value: Required Result = 0.90: = 0.95 for Metal Loads
Wet steam can cause wet loads which in turn can be considered un-sterile. In today's world, confidence of sterility is paramount. Modern packaging prevents re-infection when dry but bacterial retentive properties will be dramatically affected by the presence of moisture. A value of 1 represents steam that is completely dry and free of moisture.

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CALITECH ★★★★★ ★★★★★ 3.0/5 ★★★★★ ★★★★★3.0 out of 5 VotesRated by 1 Buyers 5★ 4★ 3★ 2★ 1★ Office Number- 108, Patil Chamber, GIDC, Telephone Exchange Road, GIDC Char Rasta, Vapi, Valsad-396195, Gujarat, India

Premal Patel (Owner)

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