Femto Scientific provides ISO/IEC 17025 accredited refrigerator and freezer calibration that keeps clinical and diagnostic laboratories CAP- and CLIA-ready — NIST-traceable certificates with as-found and as-left data and documented uncertainty for the blood-bank refrigerators, reagent storage, specimen freezers, biorepository units, and vaccine cold-chain storage your accreditation depends on.
- CAP checklist & survey-ready records
- CLIA 42 CFR 493.1252 compliant calibration
- As-found & as-left data on every certificate
- Documented measurement uncertainty (k=2)
- Blood bank, biorepository & reagent storage
- Vaccine cold-chain refrigerator calibration
- NIST-traceable references & data loggers
- Onsite service for high-volume clinical labs
Cold storage calibration records your CAP inspector can check off without a second question.
Refrigerator & Freezer Calibration Requirements for CAP and CLIA Laboratories
Clinical laboratories accredited by the College of American Pathologists (CAP) or operating under CLIA must calibrate the cold storage that holds specimens, reagents, and blood products, and keep the records available for survey. ISO/IEC 17025 accredited calibration is the cleanest way to demonstrate that competency for every refrigerator, freezer, blood-bank unit, and biorepository storage system.
CAP Survey Readiness
CAP checklists require calibration records for the refrigerators and freezers used to store patient specimens, reagents, and blood products. Our certificates document NIST-traceable calibration, the calibration date, as-found/as-left results, and reported uncertainty — exactly what surveyors expect for specimen-integrity and blood-bank storage.
CLIA 42 CFR 493.1252
CLIA requires equipment to be maintained and calibrated per manufacturer and quality-standard specifications, using NIST-traceable references within the established interval. Our accredited certificates meet those requirements for clinical cold storage and integrate directly with your LIMS.
Specimen Integrity & Cold Chain
An out-of-tolerance refrigerator can compromise specimen integrity, degrade reagents, or break the vaccine cold chain. Accredited calibration with documented uncertainty and as-found data gives you the evidence to demonstrate temperature validity — and to scope impact if a unit is found out of tolerance.
A Full Calibration, Not Just a Daily Temperature Log
A daily min/max temperature log confirms the unit is running; it is not a calibration. Accredited calibration verifies that the controller and monitoring device read accurately against NIST-traceable references and documents it for CAP and CLIA compliance. Both belong in your quality program — serving different purposes.
- Set-point verification across the clinical range
- Refrigerators (2°C–8°C), −20°C & −80°C freezers
- Blood bank (1°C–6°C) & plasma freezers
- As-found & as-left data with adjustment
- Documented expanded uncertainty (k=2)
- Electronic certificates for paperless QMS
Most CAP and CLIA laboratories calibrate cold storage at least annually. Compare service levels and turnaround on the refrigerator & freezer calibration service page, or read the companion pharmaceutical & GMP cold storage guide for GMP requirements.
CAP & CLIA Cold Storage Calibration FAQs
Blood bank refrigerators are purpose-designed cold storage units for storing red blood cell components, whole blood, and other blood products that require storage at 1 °C to 6 °C per AABB Standards for Blood Banks and Transfusion Services. They differ from standard laboratory refrigerators in several key ways: they include continuous temperature monitoring with audible and visual alarms that activate whenever the temperature falls outside 1 °C to 6 °C, they have forced air circulation to minimize temperature gradients, they are often equipped with backup power and remote alarm notification, and they are typically validated to maintain temperature during power failures for a defined period. AABB Standards require that blood bank refrigerators be monitored continuously and that temperature records be maintained. AABB accreditation requires calibration of temperature monitoring devices. For blood bank refrigerators used in CAP-accredited clinical laboratories, CAP checklist item TRM.30550 and related items address temperature monitoring and calibration requirements. Femto Scientific provides calibration services for blood bank refrigerators from all major manufacturers (Helmer Scientific, Thermo Fisher Scientific, Jewett Refrigeration, Follett), producing certificates formatted for AABB and CAP accreditation documentation.
ICH Q1A(R2) defines refrigerated storage conditions for pharmaceutical stability testing as 5 °C ± 3 °C, corresponding to a range of 2 °C to 8 °C. This is the most common specification for pharmaceutical refrigerators. Vaccine storage refrigerators must maintain 2 °C to 8 °C per CDC and WHO requirements, with a target of approximately 5 °C. Blood bank refrigerators for red blood cell storage must maintain 1 °C to 6 °C per AABB Standards. Pharmacy refrigerators storing compounded medications under USP <797> must maintain temperatures appropriate for the stored preparations, typically 2 °C to 8 °C. The specification for any particular pharmaceutical refrigerator must reference the applicable regulatory or compendial storage requirement for the specific products stored, and the refrigerator qualification must verify that the unit maintains the required temperature throughout the storage volume under the specified operating conditions.
GMP/cGMP pharmaceutical facilities: every 6 months minimum (quarterly for critical units). CAP/CLIA clinical labs: annually at minimum, semi-annual strongly recommended for blood bank refrigerators and clinical specimen freezers. Vaccine storage (CDC/VFC program): every 6–12 months with calibrated NIST-traceable monitoring. Biorepositories and cell therapy: semi-annual for −80 °C and LN2 systems. Triggered recalibration is always required after refrigeration repair, controller replacement, unit relocation, or any HVAC change affecting the storage room ambient temperature.
Documentation ranges from a calibration sticker (Level 1) through a full ISO/IEC 17025 accredited certificate with as-found/as-left data and measurement uncertainty (Level 3), to a complete GMP qualification package including temperature mapping report with all probe locations, recovery time data, door-opening study results, hot/cold spot identification, IQ/OQ/PQ protocols and reports, and FDA-audit-ready validation documentation (Level 4). All documents are delivered electronically in PDF and formatted to meet GMP, ICH, CAP, CLIA, or institutional requirements.
Yes. Femto Scientific provides calibration and qualification for liquid nitrogen cryogenic storage systems from MVE/Chart Industries, Thermo Fisher Scientific CryoPlus, and Haier Biomedical cryogenic systems. Services include cryogenic temperature verification at vapor and/or liquid phase using NIST-traceable cryogenic-grade thermocouples, alarm testing, LN2 level sensor verification, and full IQ/OQ/PQ qualification packages for GMP cell therapy, gene therapy, and biobanking programs with 21 CFR Part 11-compatible documentation.
Keep Every Clinical Refrigerator & Freezer Survey-Ready
Send us your unit count and types — we’ll return a quote with turnaround options and a recommended calibration interval that keeps your laboratory inside CAP and CLIA requirements year-round.