Cold Storage, Hot Topic: Why Freezer Calibration is Non-Negotiable in Life Sciences

Calibration
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Freezer calibration ensures that storage temperatures remain within the specified range required to preserve the quality and efficacy of sensitive materials. Deviations, even by a few degrees, can render biological samples, vaccines, or drugs ineffective or unsafe. Uncalibrated equipment may lead to:

  • Compromised Research Data: Fluctuating temperatures can degrade reagents and samples, leading to unreliable experimental results.

  • Regulatory Non-Compliance: Regulatory bodies require strict adherence to temperature controls for materials used in pharmaceutical and clinical applications.

  • Financial Losses: Damaged samples or materials often represent significant financial investments, not to mention the potential delay in project timelines.

Regulatory Requirements

The U.S. Food and Drug Administration (FDA) mandates stringent temperature monitoring and control for facilities handling biologics, pharmaceuticals, and other sensitive materials. Key regulations include:

  1. 21 CFR Part 211.94: Equipment used in storage must operate within specified temperature ranges, validated through regular calibration.

  2. 21 CFR Part 600.11: Facilities handling biological products must maintain storage conditions to ensure product potency and safety.

  3. Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP): Require facilities to document and regularly verify the performance of temperature-controlled equipment, including freezers.

Calibration records are often reviewed during inspections, making accurate and routine calibration essential to demonstrating compliance.

Types of Laboratory Freezers

Selecting the right freezer depends on the application, required temperature range, and storage volume. Common types include:

  • Ultra-Low Temperature (ULT) Freezers:

    • Temperature Range: -80°C to -40°C

    • Manufacturers: Thermo Fisher Scientific, Eppendorf, and Panasonic (now PHCbi)

    • Applications: Long-term storage of DNA, RNA, and proteins.

  • Pharmaceutical Freezers:

    • Temperature Range: -20°C to -10°C

    • Manufacturers: Helmer Scientific, Liebherr, and Stirling Ultracold

    • Applications: Storage of vaccines, medications, and biological samples.

  • Cryogenic Freezers:

    • Temperature Range: -150°C and below

    • Manufacturers: Taylor-Wharton, MVE BioMedical, and Worthington Industries

    • Applications: Preservation of cells and tissues, often in liquid nitrogen.

  • Lab-Grade Freezers:

    • Temperature Range: -30°C to 0°C

    • Manufacturers: Revco, So-Low, and VWR

    • Applications: General laboratory storage of reagents and samples.

Each freezer type demands calibration tailored to its operating range and application-specific requirements.

The Role of ISO 17025-Accredited Calibration Labs

ISO 17025 is the international standard for testing and calibration laboratories, ensuring that they deliver precise and reliable results. Working with an ISO 17025-accredited lab provides significant benefits:

  • Traceable Accuracy: Accredited labs use calibrated reference standards traceable to national or international measurement standards, ensuring accurate temperature readings.

  • Compliance Assurance: These labs are proficient in meeting FDA and other regulatory standards, minimizing the risk of non-compliance.

  • Expertise in Calibration: ISO 17025 labs are skilled in handling a wide variety of freezer brands and models, providing tailored calibration services.

  • Confidence in Results: Accreditation ensures adherence to rigorous quality management systems, bolstering confidence in the results.

Best Practices for Freezer Calibration

To maintain compliance and ensure optimal equipment performance, consider the following:

  1. Regular Calibration Intervals: Follow manufacturer recommendations and regulatory guidelines for calibration frequency.

  2. Environmental Monitoring Systems: Use digital data loggers or monitoring systems to continuously track temperature fluctuations.

  3. Comprehensive Documentation: Maintain detailed records of calibration certificates and procedures to streamline regulatory audits.

  4. Partnerships with Experts: Collaborate with ISO 17025-accredited calibration labs to ensure precision and compliance.

Freezer calibration is a non-negotiable aspect of life sciences operations, safeguarding the integrity of sensitive materials and ensuring compliance with stringent regulatory standards. From ultra-low temperature freezers to cryogenic systems, the accuracy of these critical instruments directly impacts research outcomes and patient safety. By working with ISO 17025-accredited labs and adhering to best practices, organizations can ensure the reliability and efficiency of their temperature-controlled storage solutions. Investing in proper calibration today protects the value and safety of life sciences advancements tomorrow.

Why use Tra-Cal for your freezer calibration? 

Our ISO-17025 accredited lab has calibrated freezers for the pharmaceutical, life sciences, and biotech communities for decades. Our expert technicians will come to your facility and calibrate your freezer to the manufacturer’s specifications, and you will receive a NIST-traceable calibration certificate and sticker that day. We also utilize our asset management software to store your freezer’s data and calibration certificate, and will remind you prior to the next calibration to ensure you are in compliance and audit proof. 

Here are just some of the freezer’s we calibrate at Tra-Cal:

  • Thermo Fisher Scientific

    • Forma 900 Series:  Models: 902, 905

    • Type: Ultra-Low Temperature (ULT) Freezer (-86°C)

    • Applications: Long-term storage of RNA, DNA, and proteins.

    • Revco ULT Series: Models: RDE40086A, RLE50086A

    • Type: ULT Freezer (-80°C)

    • Applications: Biologics and pharmaceutical samples.

    • TSX Series: Models: TSX60086A, TSX40086A

    • Type: High-efficiency ULT Freezers

    • Applications: Energy-efficient storage for sensitive pharmaceuticals.

  • PHCbi (formerly Panasonic Biomedical)

    • VIP ECO Series: Models: MDF-DU702VH-PA, MDF-DU502VH-PA

    • Type: ULT Freezer (-86°C)

    • Applications: Biological research and pharmaceutical manufacturing.

    • Cryogenic MDF Series: Models: MDF-C2156VAN-PA

    • Type: Cryogenic Freezer (-150°C)

    • Applications: Cell and tissue preservation.

  • Eppendorf

    • CryoCube F740 Series:

    • Models: CryoCube F740hi, F740is

    • Type: ULT Freezer (-80°C)

    • Applications: Genomic, proteomic, and vaccine storage.

    • High-Efficiency Freezers:

    • Models: F570h, F740h

    • Type: ULT Freezer (-86°C)

    • Applications: Research and clinical storage with reduced energy usage.

  • Stirling Ultracold

    • SU780XLE: Model: SU780XLE

    • Type: ULT Freezer (-86°C)

    • Applications: Biologics, vaccine, and pharmaceutical storage.

    • SU105UE Portable: Model: SU105UE

    • Type: Portable ULT Freezer (-86°C)

    • Applications: Field use for pharmaceuticals and biologics.

  • Helmer Scientific

    • GX Solutions Upright Freezer: Models: GXF500, GXF700

    • Type: Laboratory Freezer (-30°C to -20°C)

    • Applications: Pharmacy, biologics, and lab sample storage.

    • HF Series: Models: HF120, HF220

    • Type: Laboratory Freezer (-30°C)

    • Applications: General laboratory storage of reagents.

  • Taylor-Wharton (Cryogenic)

    • K Series: Models: K-Series LAB20K, LAB50K

    • Type: Cryogenic Freezer (Liquid Nitrogen)

    • Applications: Long-term cell and tissue preservation.

    • XT Series: Models: XT34, XT47

    • Type: Cryogenic Storage Dewar

    • Applications: High-volume cryogenic storage.

  • So-Low Environmental Equipment

    • Ultra-Low Freezers: Models: U85-22, U85-13

    • Type: ULT Freezer (-85°C)

    • Applications: Laboratory, pharmaceutical, and biotech research.

    • Cryogenic Freezers: Models: C85-5, C85-9

    • Type: Cryogenic Freezer (-150°C)

    • Applications: Preservation of biological samples.

  • MVE Biological Solutions

    • High-Efficiency Freezers: Models: MVE HEco 1800, HEco 800

    • Type: Cryogenic Freezer

    • Applications: Cell therapy and pharmaceutical research.

    • CryoSystem Series: Models: 6000, 4000

    • Type: Liquid Nitrogen Freezer

    • Applications: Cryopreservation of clinical samples.

  • Liebherr

    • Pharmaceutical Freezer: Models: LGPv 6520, LGUex 1500

    • Type: Pharmaceutical-grade Freezer (-30°C to -5°C)

    • Applications: Medications and vaccines.

    • Chest Freezer Series: Models: LGT 3725

    • Type: General Freezer (-45°C)

    • Applications: Storage of biological samples.

  • VWR

    • General Purpose Freezers: Models: 10761-000, 10761-002

    • Type: Lab Freezer (-30°C to -10°C)

    • Applications: Reagents and chemical storage.

    • ULT Series Freezers: Models: VWR ULT-15, ULT-25

    • Type: ULT Freezer (-86°C)

    • Applications: Biological and clinical sample preservation.

Our onsite freezer calibration service area includes:

  • Maryland

  • Pennsylvania

  • New Jersey

  • Delaware

  • Washington D.C.

  • West Virginia

  • Virginia

  • North Carolina

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