Autoclave Calibration Services in Jeddah | NABL Accredited

At Vega Calibrations, we understand that in the high-stakes industrial landscape of Jeddah—from the bustling pharmaceutical hubs in Modon Industrial City to the advanced healthcare facilities in Al-Rawdah—precision is not a luxury; it is a regulatory safeguard. Our Autoclave Calibration and Thermal Validation services are meticulously designed to ensure your sterilization equipment operates within the strictest tolerances required by international and local Saudi standards. We do not just "check" your sensors; we perform comprehensive Thermal Mapping and Heat Distribution Studies to verify that every corner of your autoclave chamber reaches the required sterilization temperature (typically 121°C or 134°C). Our service portfolio covers the entire lifecycle of autoclave validation. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Comprehensive Service Offerings

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

  • Thermal Mapping & Validation: Comprehensive temperature distribution studies for autoclaves, dry heat sterilizers (DHS), and tunnels, covering ranges from ambient to 300°C.

  • RTD (Pt-100) Sensor Calibration: Calibration of the controlling sensors and strip chart recorders used in autoclaves, with a specific focus on the sterilization band of 121°C – 134°C.

  • Pressure Gauge Calibration: Verification of the autoclave’s pressure, typically at 15 psi (1.05 bar) to 30 psi, ensuring saturated steam conditions are met.

  • Time & Timer Verification: Ensuring the "hold time" displayed on the autoclave controller matches the actual elapsed time, a critical parameter for sterilization cycles.

  • Data Logger Calibration: Calibration of the independent data loggers used for mapping to ensure the validation data itself is error-free.

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 & Biotechnology Manufacturing

Jeddah is rapidly evolving into a bio-pharma powerhouse, particularly with the expansion of Modon Industrial City 1 and Modon Industrial City 2. In this segment, the autoclave is the heart of sterile manufacturing. Pharmaceutical companies producing injectables, vaccines, or sterile ophthalmic solutions cannot afford a single degree of deviation. If an autoclave display reads 121°C but the internal chamber temperature is actually 120.5°C, the sterilization cycle may fail to destroy resistant spores like Geobacillus stearothermophilus, leading to a non-sterile batch. For our clients in the King Abdullah Economic City (KAEC) pharmaceutical clusters, our service is vital for ensuring that the final drug product poses no risk to patient health. We focus heavily on validating the "coolest point" in the chamber to ensure that even the most stubborn pathogens are eliminated, satisfying the rigorous audits conducted by the Saudi Food and Drug Authority (SFDA).

Healthcare, Hospitals, and Central Sterile Supply Departments (CSSD)

The healthcare sector in Jeddah, spanning from major government hospitals on Madinah Road to private specialty clinics in Al-Zahra, relies heavily on autoclaves to sterilize surgical instruments, gowns, and dressings. In a hospital CSSD, the volume of turnover is massive, and equipment wear and tear is high. A drifting temperature controller in a hospital autoclave can lead to the reuse of unsterile surgical tools, causing Hospital-Acquired Infections (HAIs). Our calibration services for this segment are designed to be rapid and non-intrusive to ensure 24/7 hospital operations are not disrupted. We provide certification that meets the requirements of the Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI). By validating these autoclaves, Vega Calibrations acts as a direct guardian of patient safety, ensuring that every scalpel and clamp used in operating theatres in North Obhur or Al-Balad is 100% sterile and safe for use.

Food and Beverage Processing & Packaging

The food processing units located in Jeddah Industrial City Phase 3 and near Briman utilize large industrial retorts (autoclaves) for the sterilization of canned foods, pouches, and dairy products. In this industry, the stakes are different but equally high: preventing Clostridium botulinum (botulism). The "thermal death time" of such bacteria is precise. If the autoclave fails to maintain the target temperature for the specific holding time, the food inside may rot or become toxic on the shelf. Conversely, if the temperature is too high due to a faulty controller, the food's texture and nutritional value are destroyed, leading to product wastage. Vega Calibrations helps food manufacturers in South Jeddah optimize their sterilization cycles to balance food safety with product quality, ensuring compliance with HACCP (Hazard Analysis Critical Control Point) and SFDA food safety regulations.

Scientific Research and Academic Laboratories

Jeddah is home to prestigious research institutions and universities, such as those near King Abdulaziz University and the technology zones towards Thuwal. In these research environments, autoclaves are used for two critical purposes: preparing sterile culture media and decontaminating hazardous biological waste before disposal. For a research lab, an improperly calibrated autoclave can ruin weeks of experiments by introducing contamination into culture media. More dangerously, if bio-hazardous waste is not autoclaved at the correct temperature before disposal, it poses a severe environmental health risk to the community. Vega Calibrations provides high-accuracy validation for these labs, ensuring that the "kill cycle" is effective. We understand that research samples are high-value and often irreplaceable; therefore, our calibration protocols in these academic zones are executed with extreme care to maintain the integrity of the scientific process.

Industrial Use Cases

Validation of Sterilization Cycles (F0 Value Calculation)

One of the most critical use cases for our clients in Yanbu and Rabigh is the calculation of the F0 value. The F0 value is a mathematical calculation that expresses the equivalent sterilization time at 121°C. It is not enough for an autoclave to just "reach" the temperature; it must accumulate enough heat lethality to kill bacteria. Vega Calibrations installs multiple sensors inside the chamber to calculate the accumulated F0 value during the cycle. This use case is essential for pharmaceutical companies that practice "Parametric Release," where the product is released based on process data rather than end-product sterility testing. By providing a certified F0 calculation, we allow manufacturers in Jeddah’s industrial zones to release batches faster and with higher confidence, significantly reducing inventory holding costs and improving supply chain efficiency.

Identification of "Cold Spots" via Thermal Mapping

Every autoclave, no matter how advanced, has a "Cold Spot"—the point within the chamber that is slowest to heat up. This is often near the drain or in the center of a dense load. Identifying this spot is the primary use case for our thermal mapping services in Obhur and Prince Sultan Street clinics. If the cold spot only reaches 119°C while the controller displays 121°C, sterilization is compromised. Vega Calibrations uses wireless data loggers placed in a geometric pattern throughout the chamber to hunt down this cold spot. Once identified, we configure the autoclave’s controlling probe to govern the cycle based on this worst-case location. This ensures that if the cold spot is sterile, the entire load is sterile, providing a fail-safe guarantee for medical and industrial operators alike.

Optimizing Steam Penetration for Porous Loads

In the textile and medical dressing industries found in Al-Khumra, autoclaves are used to sterilize porous loads like surgical gowns, drapes, and towels. The use case here involves ensuring that steam penetrates deep into the fabric layers rather than just treating the surface. Air pockets trapped inside porous loads act as insulators and prevent sterilization. Our calibration service involves "Bowie-Dick" test cycles and load-specific validation where sensors are buried deep inside the fabric bundles. We verify that the autoclave’s pre-vacuum pulses are effective at removing air. This is crucial for clients in King Abdulaziz Medical City areas, where a non-sterile surgical gown could lead to deep-tissue infections. We fine-tune the vacuum and pressure phases of the cycle to guarantee 100% steam penetration.

Audit Readiness and Regulatory Compliance Checks

For export-oriented businesses in Jeddah Islamic Port and Modon, the primary use case for calibration is surviving the audit. Whether it is an SFDA inspection, a US FDA audit for exporters, or an ISO 13485 surveillance visit, the first thing auditors ask for is the calibration certificate of the autoclave. They look for traceability to international standards (NIST/NABL) and proof that the instruments used for calibration were themselves valid. Vega Calibrations provides a "Gold Standard" audit folder. We don't just give a sticker; we provide a comprehensive report detailing the uncertainty of measurement, the reference standards used, and the deviation charts. This use case transforms calibration from a maintenance task into a strategic compliance asset, helping our clients in Tahlia Street corporate offices avoid warning letters and production stoppages.

Compliance & Audit Requirements

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

  • · ISO/IEC 17025:2017: The general requirement for the competence of testing and calibration laboratories. Our reports are fully compliant.

    · SFDA (Saudi Food and Drug Authority): Mandatory for all pharma and food facilities in Saudi Arabia. Requires documented evidence of sterilization efficacy.

    · SASO (Saudi Standards, Metrology and Quality Organization): General safety and quality standards applicable to industrial machinery in KSA.

    · HTM 01-05 / EN 285: Specific standards for steam sterilizers used in healthcare, detailing the pass/fail criteria for thermal profiles.

    · 21 CFR Part 11: For pharmaceutical clients, our data logging software ensures electronic records are secure and tamper-proof.

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.

  • Pan-India Presence, Local Expertise: While we serve the entire country, our dedicated teams in the Indore region ensure that we can reach your facility rapidly, minimizing your machine downtime.

  • Audit-Ready Documentation: Our calibration certificates are designed with the auditor in mind, featuring clear traceability, uncertainty calculations, and reference to international standards.

  • Holistic Solution: We don’t just stick a sticker on your gauge. We analyze the health of your control loop, advise on sensor placement, and help you troubleshoot heating issues, ensuring you pass your audits with flying colors.

Frequently Asked Questions (FAQs)

Q: Can you perform thermal validation for autoclaves in Modon Industrial City?

A:· Absolutely. We service all industrial zones in Jeddah, including Modon 1, 2, 3, and the warehouse districts near the Port.

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: What is the difference between Controller Calibration and Thermal Mapping?

A: Controller calibration checks the accuracy of the sensor displaying the temperature. Thermal mapping uses multiple independent sensors (dataloggers) placed throughout the chamber to ensure the temperature is uniform in every corner, not just where the controller sensor is located.

"Operating a sterile manufacturing unit in Modon Industrial City Phase 3 requires zero margin for error. Vega Calibrations handled our annual autoclave validation with incredible professionalism. Their thermal mapping pinpointed a cold spot we hadn't noticed for years. Highly recommended for SFDA compliance." Quality Assurance Manager, Pharmaceutical Co., Jeddah

"Our hospital in Al-Rawdah has a very busy CSSD. We needed a partner who could work over the weekend to calibrate our sterilizers. Vega’s team was punctual, and their reports were detailed enough to sail through our CBAHI accreditation." Head of Biomedical Engineering, Private Hospital, Jeddah

"We process packaged food in Jeddah Industrial City 2. Temperature control is vital for our retort pouches. Vega provided us with excellent insights into our heat distribution, helping us reduce cycle times while maintaining safety. A true technical partner." Plant Manager, Food Processing Group, South Jeddah

Customer Testimonials