NABL Accredited Autoclave Calibration Services in Manesar | Thermal Validation

Comprehensive Service Offerings

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

• Thermal Mapping & Validation: We place multiple sensors (as per 1m³ volume rules) inside the chamber to map temperature distribution, identifying cold spots and ensuring the "F0 Value" (sterility assurance level) is achieved throughout the load.

• Loop Calibration: We calibrate the entire measurement chain, from the Temperature Controller display to the RTD sensor inside the chamber, ensuring what you see on the panel is exactly what is happening inside.

• Pressure Gauge Calibration: Since steam sterilization relies on saturated steam physics, we calibrate the pressure gauges to ensure the pressure-to-temperature correlation is correct.

• Time-Temperature Profile Verification: We verify the "Hold Time" accuracy of your controller to ensure the load is exposed to the sterilizing temperature for the exact required duration.

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 & Biotechnology

The pharmaceutical industry in hubs like Manesar and nearby Gurugram relies on autoclaves as the primary defense against biological contamination. In this segment, the margin for error is effectively zero. Autoclaves are used for sterilizing porous loads (garments, filters), liquid loads (vials, ampoules), and solid equipment (stainless steel vessels). The calibration of these units is not just a maintenance task; it is a regulatory mandate under GMP and WHO guidelines. If a pharmaceutical autoclave’s temperature controller drifts by even 0.5°C below the setpoint, the sterilization cycle may fail to kill resistant spores like Geobacillus stearothermophilus, rendering an entire batch of life-saving drugs unsafe. Vega’s services ensure that every sensor within the autoclave—from the drain probe to the active chamber probes—is reading accurately. We help these facilities prove "Sterility Assurance" to auditors by validating that the equipment consistently delivers the required lethality (F0 value) across all load configurations, preventing costly recalls and ensuring patient safety.

Healthcare, Hospitals, and Biomedical Waste Facilities Hospitals

Healthcare, Hospitals, and Biomedical Waste Facilities Hospitals and Central Sterile Services Departments (CSSD) in Delhi NCR, including Faridabad and Noida, utilize autoclaves to sterilize surgical instruments, dental tools, and linens. In this segment, the calibration of autoclaves is directly linked to infection control. A poorly calibrated autoclave can lead to Post-Operative Infections (surgical site infections), which are a massive liability and health risk. Furthermore, biomedical waste treatment facilities in areas like Bhiwadi and Sonipat use massive industrial autoclaves to decontaminate hazardous waste before disposal. For these heavy-duty machines, the challenge is often uneven steam penetration due to dense waste loads. Vega Calibrations provides robust calibration services that verify the steam quality and temperature uniformity even in these challenging environments. We ensure that the temperature controllers are strictly adhering to the 121°C mandate for the required time, providing the documentation needed for NABH accreditation and Pollution Control Board (PCB) audits.

Automotive and Aerospace Composites Manufacturing

While often associated with biology, autoclaves are critical in the heavy engineering sectors found in IMT Manesar, Neemrana, and Rewari. Here, industrial autoclaves are used for curing carbon fiber composites and bonding layers of materials under high heat and pressure. Unlike sterilization, the goal here is material structural integrity. The temperature controller must execute complex "ramp and soak" profiles where the temperature rises at a specific rate to cure the resin without cracking it. If the calibration is off, the composite parts—used in vehicle chassis or aircraft components—may suffer from delamination, voids, or incomplete curing. Vega’s calibration services for this segment focus on the precision of the programmable logic controllers (PLCs) and the uniformity of heat distribution. We ensure that the pressure and temperature curves match the engineering specs exactly, preventing the production of brittle or structurally unsound parts that could fail catastrophically in the field.

Food Processing and Canning Industry

The food processing belt extending towards Panipat and Sohna utilizes autoclaves (often called retorts) for the commercial sterilization of canned foods, pouches, and ready-to-eat meals. In this industry, the "Botulinum Cook" (121°C for 3 minutes equivalent) is the gold standard to prevent Botulism, a deadly foodborne illness. Calibration here is a matter of public health and brand survival. If a retort’s temperature controller reads 121°C when the actual temperature is 119°C, the food inside may rot or harbor deadly toxins, leading to massive product recalls and brand destruction. Conversely, if the temperature is too high, the food overcooks, destroying its texture, taste, and nutritional value. Vega Calibrations acts as a critical partner for food manufacturers, calibrating their retort control systems to ensure the delicate balance between food safety and food quality. We verify that the thermal process is delivered accurately to the "Cold Point" of the can or pouch, ensuring a long shelf life without preservatives.

Industrial Use Cases

Sterility Assurance Validation (F0 Calculation) in Pharma

A prominent use case in the pharmaceutical plants of Gurugram and Pataudi involves the validation of the "F0 value." A Quality Assurance Manager might face a situation where a batch of injectable vials must be sterilized. The protocol demands that the load be exposed to 121°C for 15 minutes to achieve a specific microbial kill rate. However, the autoclave controller only measures the temperature at the drain, not inside the vials. Vega’s team intervenes by introducing independent, calibrated data loggers directly into the vials (the load) during a validation run. We might discover that while the controller shows 121°C, the liquid inside the vials only reaches 118°C due to lag time. Using this data, we calculate the actual F0 value and help the customer adjust the cycle time (e.g., extending it to 20 minutes) to compensate. This use case transforms calibration from a tick-box exercise into a process optimization tool that guarantees product safety.

Composite Curing Uniformity for Auto Parts

Consider a manufacturer in Bawal or Dharuhera producing carbon fiber hoods for high-performance cars. They use a large industrial autoclave to cure the resin. The use case here revolves around "Thermal Uniformity." The part is large, and if one side of the autoclave is 5°C hotter than the other due to poor air circulation or uncalibrated sensors, the resin will cure unevenly, leading to warping or internal stress. The manufacturer calls Vega for a thermal survey. We place 12 to 16 sensors across the autoclave volume and run a mock cure cycle. Our data reveals the "hot" and "cold" zones of the vessel. Based on our report, the maintenance team adjusts the baffles and fan speeds or applies offsets to the multi-loop temperature controller. This ensures that every square inch of the carbon fiber part experiences the exact same thermal profile, resulting in a defect-free, high-strength component ready for assembly.

Microbiological Media Preparation in Research Labs

Research and testing laboratories in Manesar and Delhi frequently use autoclaves to prepare culture media (agar) for microbiological testing. The use case here is preventing the "Caramelization" of media. If the autoclave gets too hot (overheating due to poor calibration), the sugars in the growth media burn (caramelize), which inhibits bacterial growth and ruins the experiment. Conversely, if it doesn't get hot enough, the media isn't sterile, leading to contamination of the cultures. A Lab Manager realizes their experiments are failing and suspects the autoclave. Vega performs a calibration and finds the temperature controller is reading 2°C lower than the actual temperature, causing the heaters to overdrive the chamber to 123°C instead of 121°C. By correcting this offset, we restore the integrity of their research, saving the lab time and money on wasted reagents and failed experiments.

Medical Waste Decontamination for Regulatory Clearance

A biomedical waste treatment plant near Bhiwadi or Noida processes tons of infectious waste daily. Their use case is strictly regulatory. They must prove to the Pollution Control Board that their autoclave cycles are successfully decontaminating the waste before it goes to a landfill. The challenge is that waste bags are dense and difficult to penetrate with steam. The facility manager uses Vega’s services to perform a "Load Challenge" study. We place biological indicators (spore strips) and temperature sensors deep inside the densest waste bags during a cycle. The data might show that the center of the waste load is not reaching the required temperature. We then help the facility redesign their loading pattern—spacing bags out or using different containers—and recalibrate the controller to run a "pre-vacuum" pulse more aggressively. This ensures complete steam penetration, regulatory compliance, and environmental safety.

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.

• 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.

• Rapid Mobilization: Our teams can reach sites in Rewari, Bilaspur, or Sonipat quickly to minimize your machine downtime.

• Audit-Ready Reports: Our certificates are designed to pass the scrutiny of the toughest auditors, from the USFDA to local government bodies.

• One-Stop Solution: From calibrating the temperature controller to mapping the entire autoclave chamber, we handle it all.

• Pan-India Reach: While we serve the Manesar belt deeply, our standardized quality allows us to serve your sister plants in Gujarat, Maharashtra, or the South with the same excellence.

Frequently Asked Questions (FAQs)

Q: How often should I calibrate my autoclave in Manesar?

A: Regulatory bodies like the FDA and NABL typically recommend calibration every 6 months, or annually at a minimum. However, heavy-use autoclaves in pharma or hospitals may require quarterly checks.

Q: What is the difference between Autoclave Calibration and Validation?

A: Calibration checks if the sensors and controllers are accurate (e.g., Is the display reading 121°C when the sensor sees 121°C?). Validation (IQ/OQ/PQ) proves the process actually sterilizes the load (e.g., Did the steam penetrate the center of the bag?). Vega offers both.

Q: Why do my Bowie-Dick tests fail after calibration?

A: A failed Bowie-Dick test usually indicates a vacuum leak or poor steam quality (non-condensable gases), not necessarily a temperature error. Our team can help troubleshoot vacuum levels and steam supply issues during our visit.

Q: Can you calibrate autoclaves onsite in IMT Manesar?

A: Yes, we specialize in onsite calibration. We bring our portable dry blocks, oil baths, and reference sensors to your facility in IMT Manesar, Gurugram, or Dharuhera to calibrate the equipment without moving it.

"We run a high-volume sterile injectables plant in IMT Manesar. We faced constant audit observations regarding our autoclave temperature distribution. Vega’s team didn’t just calibrate the controllers; they performed a full thermal mapping that identified a cold spot near the drain. Their detailed root-cause analysis helped us fix the issue. Truly professional service." — Rajesh K., Quality Assurance Manager, Pharmaceutical Sector

"As an auto-component manufacturer in Bhiwadi, curing our composite parts requires absolute temperature precision. Vega Calibrations has been our partner for three years. Their technicians are always on time, and their calibration of our high-pressure autoclaves ensures our parts never fail the stress tests." — Amit V., Plant Head, Automotive Composites

"Running a busy hospital in Gurugram, we cannot afford downtime in our CSSD. Vega’s team calibrated our four steam sterilizers over a weekend. Their reports were spotless and helped us sail through our recent NABH assessment without a single non-compliance." — Dr. S. Mehra, Medical Director, Healthcare

Customer Testimonials