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
Pressure & Vacuum Calibration
- Pressure / Vacuum / Compound Gauge/Indicator/Recorders
- Inclined Manometers / Magnehelic / Photohelic Gauge /Manometers
- Pressure / Vacuum Switch & Transmitter
- Absolute Pressure Gauge/Transmitter
- Pressure / Vacuum Transducer/Sensor
- Differential Pressure /Vacuum Gauge/Indicator/Transmitter
- I / P Convertor
- BP Apparatus Safety Valve
- Safety /Control Valves
Analog Pressure Gauge
Digital Pressure Gaue
Digital Pressure Gauge
Pressure Gauge With Pneumatic Pump
Dimensional Metrology Calibration
- Digital / Analog Vernier Caliper
- Digital / Analog Height Gauge
- Micrometer/Micrometer Setting Standards
- Measuring Scale / Tape / Rule
- Thickness Gauge / Dial Gauge/Depth Gauge/Ball
- Filler Gauge/ Measuring Pin
- Combination Set/Degree/Bevel Protractor
- Test Sieve
- Measuring Cylinder / Beaker / Flask
- Glass pipette
- Weight Box
- Standard Weights
- Weighing Balance
Standard Weight Box
Weighing Balance Platform
- Digital Tachometer
- Tachometer Calibrator
Sound Level Calibrator
Sound Level Meter Dispaly
Electro Technical Calibration
- Temperature Indicator/Controller/Scanner
- Strip Chart Recorder
- Data Logger
- A.C./ D.C. Voltmeter/Ammeter
- Resistance Meter/ Megger/ Insulation Tester/Earth Tester
- Frequency Meter
- Timer/Stopwatch /Clock/Hour Meter
- Clamp Meter
- Digital/ Analog Multimeter
- Multifunction(Universal ) Calibrator
Temperature Indicator with Sensor
Wireless Data Logger
Temperature and Humidity Calibration
- Temperature Sensor with/without Temperature Indicator / Controller
- Glass / Room / Wall /Wet & Dry / Min Max Thermometer /Temperature Guage
- Digital Hygrometer/Room Monitoring Device
- Temperature Transmitter with /without Indicator
- Temperature Transmitter with Indicator
- Humidity Indicator with Sensor Humidity Transmitter with sensor
- Digital Thermometer
- Infrared Thermometer
- RH Sensor
- Wireless Temperature & RH Data
- Temperature RH Indicator Controller with/without Sensor
- Temperature Bath/Calibrator
- Hot Plate
- Water Bath
- Melting Point Apparatus
- BOD Incubator
- Hot Air Oven
- Muffle Furnace
- Stability Chamber
- HPLC Oven
General Laboratory Equipments Calibration
Tablet Harness Tester
- Lux Meter
- Anemometer/Air Velocity Meter
- pH/Conductivity/ORP Meter with Sensor
- pH/Conductivity/ORP Transmitter
- Tablet Hardness Tester
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).
- Cold Room
- Clean Room & Production Areas
- Stability Chambers
- Cold Chambers / Refrigerator
- De-progenation Ovens / Lab Ovens
- Muffle Furnace
- HPLC/GC Column Oven
- Temperature & Humidity Chamber
Hot Air Oven
HVAC & Clean Room Validation
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.
- Filter Integrity Leak Test (Using PAO / DOP)
- Air Borne Particle Count Test
- Recovery Time Studies
- Air Flow Visualization Test (Smoke Test)
- Air Velocity Measurement
- Air Changes Per hour
- Pressure Balancing Test
- Temperature & Humidity Test
- Light Intensity Measurement
- Sound Level Measurement
2i AT Iphotometer
System Quality Test
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.
- Dryness Value Test
- Superheat Value Test
- Condensable Gases Test
Comp. Air Validation
Compressed Air Validation & Nitrogen Air Validation
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.
- Non Viable Particle Count Test
- Dew Point Temperature
- Moisture Content
- Nitrogen Oxide
- Hydrogen Sulphide
- Sulpher Dioxide
- Carbon Monoxide
- Carbon Dioxide
- Water Vapour
- Nitrogen Air Validation
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.
Scope of Work
- PLC base Control systems.
- PLC base Control Systems with HMI/MMI user interface+Camera System.
- PLC base Control Systems with SCADA.
- Micro-Controller base control system.
- Operating Software for the SCADA.
- Equipment Validation (Incubator, Stability,etc..)
Computer System Validation Services Deliverables
- Qualification Doc. : GxP, RA, GAP, CSVP, IQ, OQ, PQ ,(If required),VSR , Test cases (if required) etc.
- Re-Qualification Doc. : RA, Requalification Protocol (Including IQ,OQ,PQ ), Test cases (if required) etc.
- Re-Validation Doc. : Performance Verification Protocol (Including IQ,OQ), Test cases (if required)
Work flow for computer system validation
- Master Validation Plan
- User Requirement Specifications
- Collection Of Raw Data Information And Required Reference Documents
- Gxp Assessent
- Risk Assessment
- Gap Assessment
- Generation Of Protocols/Reports (IQ, OQ & PQ)
- Execution Of Protocols/Reports (IQ, OQ & PQ) & Compiling
- Acceptance Criteria
- Deficiency Report
- Change Control
- Corrective Action & Preventive Action
- Final Submission Of All Reports
- Validation Summary Report