NABL Accredited Autoclave Calibration Services in Lucknow | Thermal Validation

Comprehensive Service Offerings

Under our NABL scope, we offer specialized calibration for various configurations:

• Single-Point & Multi-Point Calibration: Calibration of the autoclave’s controlling RTD sensors at critical setpoints (e.g., 121°C, 134°C) to ensure linearity and accuracy.

• Temperature Distribution Studies (Mapping): Placing 10-16 independent sensors throughout the empty and loaded autoclave chamber to verify temperature uniformity as per HTM 2010 and EN 285 standards.

• System Accuracy Tests (SAT): Verifying the accuracy of the temperature controller, chart recorder, and data logger against a calibrated reference standard.

• Vacuum Leak Test Verification: For pre-vacuum autoclaves used in hospitals in Alambagh and Charbagh, we verify the vacuum phase to ensure efficient steam penetration.

Types of NABL Temperature Calibration Services

Our service portfolio is designed to cover the entire lifecycle of your temperature sensors. We offer :

• Single-Point Calibration: Verification of the controlling sensor at the sterilization set-point (e.g., 121°C).

• Multi-Point Uniformity Survey: Placing 9 to 16 sensors (depending on chamber size) to map the temperature distribution and identify "Cold Spots."

• Load Configuration Validation: Testing specific load patterns (e.g., vials, garments, waste) to ensure steam penetration into the densest part of the load.

• Biological Indicator (BI) Co-relation: Running biological challenges alongside thermal sensors to provide double-validation of sterility.

• Pressure & Timer Calibration: Calibrating the pressure gauges and cycle timers that work in tandem with temperature to ensure saturated steam conditions.

Get in touch

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Phone

+91 91676 71931

Email

support@vegacalibrations.com

Industry Segments We Serve

Pharmaceutical Manufacturing & Formulation Units

Lucknow and nearby industrial hubs like Kanpur and Unnao are home to growing pharmaceutical formulation plants. In this segment, the autoclave is a critical process equipment used for terminal sterilization of injectables, vials, and ampoules. The industry operates under the strictest regulations where a single temperature deviation can lead to a rejected batch worth millions. The calibration of autoclaves here is not just a maintenance task; it is a regulatory mandate. Manufacturers must demonstrate to auditors that their sterilization cycles are reproducible and effective. This requires high-precision calibration of the master sensors and periodic thermal validation to prove that the heat penetrates the densest part of the load. Without NABL-accredited calibration certificates, these facilities cannot export their products or pass CDSCO inspections.

Healthcare Institutions & Central Sterile Services Departments (CSSD)

The healthcare sector in Lucknow, encompassing major super-specialty hospitals in Hazratganj and Indira Nagar, relies heavily on autoclaves for infection control. Every surgical instrument, from scalpels to forceps, must undergo steam sterilization in the CSSD. If an autoclave's temperature controller is inaccurate, the instruments may not be sterile, leading to Hospital-Acquired Infections (HAIs). This segment requires rigorous calibration to ensure patient safety. Unlike industrial setups, hospitals often run autoclaves 24/7, leading to sensor drift. Regular calibration services ensure that the "Kill Time" for bacteria is achieved during every cycle, protecting both the patients and the hospital’s reputation from negligence claims.

Biotechnology & Research Laboratories

Lucknow is a hub for premier research institutes (like CDRI, NBRI, and IITR) located near Jankipuram and University Road. These labs utilize autoclaves for the sterilization of culture media, glassware, and biological waste. In a research setting, the integrity of the experiment depends on the purity of the media. If the autoclave fails to sterilize the agar media due to a temperature error (e.g., reaching only 118°C instead of 121°C), the cultures may become contaminated, ruining months of research data. Furthermore, laboratories handling bio-hazardous materials must ensure effective decontamination before disposal. Calibration ensures that these autoclaves function within tight tolerances, supporting the validity of scientific outcomes and safety protocols.

Food Processing & Dairy Industries

The food processing belt around Chinhat and Sarojini Nagar utilizes retorts and autoclaves for the sterilization of packaged foods and dairy products. In this industry, the goal is "Commercial Sterility"—destroying Clostridium botulinum spores while preserving the food's texture and taste. This balance requires extremely precise temperature control. If the temperature is too high, the food cooks too much, affecting quality; if it is too low, dangerous pathogens survive. Calibration services in this segment verify the accuracy of the thermal processing equipment, ensuring compliance with FSSAI regulations. It serves as a Critical Control Point (CCP) verification in the HACCP plan, directly impacting public health and shelf-life stability.

Industrial Use Cases

Validation of Sterilization Cycles (F0 Value Calculation)

A primary use case for our services in the pharmaceutical sector is the calculation of the F0 value—a measure of the lethality of the sterilization process. A client in Talkatora Industrial Estate may run an autoclave cycle set at 121°C for 15 minutes. However, the physical placement of the load might obstruct steam flow, causing the actual temperature inside the product vials to lag behind. Vega’s technicians place probes inside the dummy load during a validation run. We measure the accumulated heat exposure over time. If the calculated F0 value is below the required threshold (e.g., F0 < 12), the cycle is deemed non-compliant. Our data allows the client to adjust their cycle time or temperature setpoint to guarantee sterility assurance.

Identification of "Cold Spots" via Thermal Mapping

Every autoclave chamber has a specific "Cold Spot"—the point that is slowest to heat up. Identifying this spot is crucial for sensor placement. For a hospital in Mahanagar, we perform a "Temperature Distribution Study" using 12 wireless data loggers distributed geometrically within the empty chamber. We might discover that the bottom-rear corner is consistently 1.5°C cooler than the center due to condensate accumulation. This use case provides the facility manager with actionable data: the controlling sensor must either be moved to this cold spot, or an offset must be applied to the controller to ensure every point in the chamber reaches the sterilization temperature. This prevents partial sterilization where half the load is sterile, and the other half is not.

Audit Defense and Regulatory Compliance

During a regulatory audit (e.g., WHO-GMP or USFDA), inspectors invariably ask for the "Calibration Master Plan" and validation reports of critical equipment. A common use case involves a Quality Assurance manager in Nadar or Aminabad using Vega’s calibration certificates to answer audit observations. If an auditor questions the reliability of the autoclave's digital display, the manager presents our NABL-traceable certificate which proves the display was compared against a primary standard and found to be accurate within ±0.2°C. Furthermore, our "As-Found" and "As-Left" data demonstrates that the instrument is well-maintained, turning a potential compliance risk into a demonstration of quality control excellence.

Correction of Sensor Drift and Controller Offsets

Over time, the RTD sensors and PID controllers in autoclaves drift due to thermal cycling (heating and cooling repeatedly). A manufacturing unit on Kanpur Road might notice that their autoclave batches are showing signs of moisture retention or "wet packs," indicating issues with the steam cycle. Our use case involves diagnosing this thermal discrepancy. We might find that the sensor is reading 2°C higher than the actual temperature. This means when the controller thinks it is at 121°C, the chamber is actually at 119°C. Vega technicians not only identify this error but can often program a "Bias" or "Offset" into the temperature controller (if accessible) to correct the reading, restoring the machine to operational accuracy without the need for expensive hardware replacement.

Compliance & Audit Requirements

In industrially advanced landscape, data integrity for temperature measurement is the key to passing inspections:

• ISO/IEC 17025:2017: The global standard for calibration competence. All our reports are traceable to National Standards (SI Units).

• WHO-GMP & Schedule M: For pharma units, we provide the necessary documentation to prove equipment qualification (IQ/OQ/PQ).

• USFDA 21 CFR Part 11: Our data loggers and software generate tamper-proof reports required for electronic record compliance.

• NABH (National Accreditation Board for Hospitals): We help hospitals in Chowk and Gomti Nagar meet the CSSD quality indicators required for NABH accreditation.

• ISO 17665-1: Sterilization of health care products — Moist heat requirements.

Why Vega is Your Trusted Calibration Partner

At Vega, we don't just act as a vendor, we act as an extension of your Quality Assurance team.

• Speed: We understand that downtime in Amausi or Chinhat industrial areas costs money. We offer rapid mobilization of our validation teams.

• Expertise: Our engineers are trained to handle complex biological indicators and thermal mapping challenges.

• Pan-India Reach: Whether you have a clinic in Aliganj or a large plant in Raebareli, our standardized service quality remains the same.

• One-Stop Solution: From calibrating the pressure gauge on the autoclave to validating the entire thermal cycle, we handle it all.

Frequently Asked Questions (FAQs)

Q: Why is NABL accreditation important for autoclave calibration in Lucknow?

A: NABL accreditation (ISO 17025) ensures that the calibration results are accurate, reliable, and internationally accepted. For industries in Lucknow exporting products or seeking NABH/USFDA approval, NABL reports are mandatory to prove competence.

Q: What is the difference between calibration and validation?

A: Calibration checks if the temperature sensor and controller are reading accurately against a standard. Validation (Mapping) confirms that the entire chamber and the load reach the required temperature uniformly for the required time. Vega offers both.

Q: Can you help us determine the "Hot" and "Cold" spots?

A: Yes, our thermal mapping service specifically identifies the hottest and coldest points inside the chamber to determine the worst-case scenario.

Q: My autoclave printer shows the correct temperature. Do I still need calibration?

A: Yes. The printer takes data from the controller sensor. If that sensor has drifted, the printer will print "121°C" even if the actual heat is only 118°C. Only an external reference sensor can detect this error.

"We run a critical sterile injectable facility near Chinhat Industrial Area. We used to face repeated observations regarding our autoclave cycles during audits. Vega Calibrations stepped in and performed a detailed thermal mapping study. Their ability to identify the cold spot and calibrate our controllers has made our audits stress-free. Highly recommended for Pharma compliance." — Dr. S. K. Verma, Quality Head, Pharmaceutical Formulation Plant, Lucknow.

"As a NABH accredited hospital in Gomti Nagar, our CSSD protocols are strict. Vega’s team was professional, punctual, and very knowledgeable. They calibrated our steam sterilizers and provided the certificates within 48 hours. Their service quality is at par with the best in the metro cities." — Mrs. Anjali Mishra, CSSD Manager, Super Specialty Hospital, Lucknow.

"Our food processing unit in Kanpur Road requires precise retort sterilization. Vega’s technicians helped us optimize our cycle times through their validation services, saving us energy and ensuring product safety. They are the go-to experts for thermal validation in UP." — Rajesh Gupta, Plant Manager, Frozen Food Exporters, Lucknow.

Customer Testimonials