- ISO/IEC 17025:2017 Accredited Calibration Laboratory
- NIST Traceable Temperature Calibration Certificates
- Refrigerators (2°C–8°C), −20°C, −80°C & −196°C Cryogenic Storage
- All Makes and Manufacturers Serviced
- Nationwide Onsite Cold Storage Calibration & Validation
- GMP, cGMP, CAP, CLIA, FDA & USP Compatible Documentation
- Temperature Mapping Studies & IQ/OQ/PQ Qualification
- Vaccine, Pharmaceutical & Biorepository Storage Compliance
Complete Cold Storage Calibration & Validation — Pharmaceutical, Clinical, Biorepository & Cryogenic
Cold Storage Calibration by Regulatory Environment
Compliance-focused guides to NIST-traceable cold storage calibration, temperature mapping, recovery time and door-opening studies, IQ/OQ/PQ qualification, and −80°C ultra-low & −196°C cryogenic storage — written for your regulatory framework, whether you run a pharmaceutical GMP operation or a CAP/CLIA clinical laboratory.
Cold Storage Calibration & Validation for All Major Manufacturers
NIST-traceable calibration performed with certified reference thermometers and NIST-traceable data loggers. A partial list of manufacturers we service across all temperature ranges:
- Thermo Fisher Scientific — TSX Series II ULT, Forma ULT, Revco, laboratory refrigerators, and cryogenic systems
- PHCbi (Panasonic/MHI) — VIP Series ULT, Premium Series, MDF and MPR series medical-grade freezers
- Helmer Scientific — i.Series refrigerators, GX Solutions plasma freezers, and laboratory cold storage
- Eppendorf — CryoCube series, standard ULT freezers, and cryo storage systems
- MVE / Chart Industries — cryogenic LN2 biological storage systems, SC and XC series
- Stirling Ultracold — SU780XLE, SU105UE, and SXL Series ultra-low freezers
- K2 Scientific — pharmacy refrigerators, vaccine storage, and ULT freezers
- VWR — laboratory refrigerators, undercounter freezers, and upright ULT storage
- Haier Biomedical — DW-86L and DW-150W series ultra-low and cryogenic storage
- And many more — contact us if your manufacturer is not listed
What Is Included in Every Cold Storage Calibration Service
- NIST-traceable temperature probe calibration with current calibration certificates on all reference equipment
- Set-point verification at all programmed temperature set points across the full operating range
- High and low temperature alarm function testing and documentation
- Temperature uniformity check across accessible chamber locations
- Compressor performance and refrigerant system assessment
- Calibration sticker with unique barcode for laboratory asset tracking
- As-found temperature data documenting unit condition before service
- As-left temperature data after any adjustment or repair
- Electronic calibration report formatted for QMS and LIMS integration
- Happiness Guarantee on every calibration service
Basic calibration verification with sticker — the standard choice for internal quality programs that do not require a formal compliance certificate.
| Service Includes | Level 1 | Level 2 | Level 3 | Level 4 |
|---|---|---|---|---|
| NIST-Traceable Probe Calibration | ✔ | ✔ | ✔ | ✔ |
| Set-Point Verification | ✔ | ✔ | ✔ | ✔ |
| Alarm Function Testing | ✔ | ✔ | ✔ | ✔ |
| Calibration Sticker with Barcode | ✔ | ✔ | ✔ | ✔ |
| Calibration Certificate with As-Left Data | – | ✔ | ✔ | ✔ |
| As-Found and As-Left Temperature Data | – | – | ✔ | ✔ |
| Documented Measurement Uncertainty | – | – | ✔ | ✔ |
| ISO/IEC 17025 Accredited Certificate | – | – | ✔ | ✔ |
| Full Temperature Mapping Study (9-Point+) | – | – | – | ✔ |
| Recovery Time & Door Opening Testing | – | – | – | ✔ |
| IQ/OQ/PQ Qualification Package | – | – | – | ✔ |
| Options (All Levels) | ||||
|
Express Turnaround
24 hr / 48 hr / 72 hr
|
✔ | ✔ | ✔ | ✔ |
| Onsite Service at Your Facility | ✔ | ✔ | ✔ | ✔ |
| Repair & Adjustment if Out of Tolerance | ✔ | ✔ | ✔ | ✔ |
| Preventative Maintenance | ✔ | ✔ | ✔ | ✔ |
| Annual / Semi-Annual Calibration Program | ✔ | ✔ | ✔ | ✔ |
| Fleet / Multi-Unit Service Agreement | ✔ | ✔ | ✔ | ✔ |
Level 3 and Level 4 calibration and validation documentation satisfies FDA 21 CFR Part 211, CAP, CLIA, cGMP, GLP, and GxP cold storage compliance requirements. Level 4 temperature mapping and IQ/OQ/PQ packages meet ICH Q1A/Q1B pharmaceutical stability storage conditions and USP biologics storage requirements.
Cold Storage Calibration & Validation for Regulated Laboratory Environments
Femto Scientific’s ISO/IEC 17025 accredited calibration certificates and temperature mapping validation packages meet the requirements of the most demanding cold storage regulatory frameworks.
GMP & cGMP — FDA 21 CFR Part 211
cGMP requires that cold storage equipment used in pharmaceutical manufacturing be qualified (IQ/OQ/PQ), periodically calibrated on a documented schedule, and maintained with complete measurement traceability records. Our ISO/IEC 17025 accredited certificates with as-found/as-left temperature data and documented measurement uncertainty satisfy FDA 21 CFR Part 211 equipment qualification requirements and support manufacturing change control programs.
ICH Q1A/Q1B — Pharmaceutical Stability Storage
ICH Q1A(R2) and Q1B specify the temperature and humidity storage conditions required for pharmaceutical stability testing programs: long-term (25°C/60%RH), intermediate (30°C/65%RH), and accelerated (40°C/75%RH) storage, as well as refrigerated (5°C±3°C) and frozen (−20°C±5°C) conditions. Our temperature mapping studies and calibration documentation verify compliance with ICH stability chamber specifications and support stability program regulatory submissions.
FDA Vaccine & Biologics Storage Compliance
FDA regulations require that vaccines and biological products be stored under continuously monitored, calibrated conditions. The CDC Vaccine Storage and Handling Toolkit specifies that vaccine storage units be calibrated with a calibrated thermometer and that calibration records be maintained. Our NIST-traceable calibration certificates and vaccine refrigerator validation packages satisfy CDC, FDA, and ACIP cold chain requirements for all vaccine types and storage unit classes.
CAP & CLIA Clinical Laboratory Cold Storage
CAP and CLIA require that all cold storage equipment in clinical laboratories be maintained and calibrated on a documented schedule, with temperature records available for inspector review. CAP checklist items specifically address calibration of refrigerators and freezers used for specimen storage, reagent storage, and blood banking. Femto Scientific’s accredited calibration records satisfy CAP and CLIA documentation requirements and are formatted for direct inclusion in your laboratory quality manual.
Cold Storage Calibration Frequency by Laboratory & Regulatory Environment
Calibration frequency for refrigerators, freezers, and cryogenic storage must be established based on the regulatory framework, instrument criticality, stored product risk, and institutional SOP requirements. The guidelines below reflect common regulatory expectations — Femto Scientific can help you establish and document the appropriate schedule for your compliance program.
Cold storage units used in GMP pharmaceutical manufacturing, compounding, and stability programs are typically calibrated every 6 months, with quarterly calibration for critical storage units (e.g., primary drug substance refrigerators, -80°C sample archives). Calibration schedules must be documented in the instrument qualification master file and reviewed during FDA inspections.
Clinical laboratories operating under CAP or CLIA are required to calibrate all cold storage units used for patient specimens, reagents, and controls at minimum annually. CAP and CLIA inspectors review calibration records during accreditation surveys — non-compliant or undocumented calibration is a common finding. Semi-annual calibration is recommended for clinical freezers and blood bank refrigerators.
The CDC Vaccine Storage and Handling Toolkit requires that vaccine storage refrigerators and freezers use a calibrated temperature monitoring device with current NIST-traceable calibration. Calibration is recommended every 6–12 months depending on unit type and immunization program requirements. VFC (Vaccines for Children) program participants must maintain calibration records as part of program compliance documentation.
Biorepositories, biobanks, and cell therapy storage facilities (including CAR-T and stem cell storage) calibrate cold storage and cryogenic systems semi-annually, or more frequently for units storing irreplaceable clinical samples. Full temperature mapping validation is typically required annually or following any equipment repair or HVAC modification affecting storage room conditions.
Frequently Asked Questions About Refrigerator & Freezer Calibration
Ultra-low freezer calibration is the process of verifying that a −80 °C storage unit is maintaining temperature within its specified range using NIST-traceable reference standards. A complete calibration includes set-point verification with a calibrated reference thermometer, alarm function testing, as-found and as-left temperature documentation, and an ISO/IEC 17025 accredited calibration certificate. Femto Scientific performs ULT calibration from basic point calibration to full GMP IQ/OQ/PQ qualification with multi-point temperature mapping studies. All reference instruments are NIST-traceable with calibration certificates valid at cryogenic temperatures.
Calibration verifies that the freezer’s temperature sensor and display are accurate — a point measurement at the set-point comparing the freezer’s reading against a NIST-traceable reference. Temperature mapping is a spatial uniformity study using multiple calibrated data loggers at 9 or more positions to characterize temperature distribution, hot spots, cold spots, recovery time, and door-opening impact across the entire chamber over 24–72 hours. A freezer can pass a point calibration while having significant temperature gradients that endanger stored samples — only mapping reveals this. Mapping is required for GMP pharmaceutical storage qualification and ICH stability chamber validation.
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.
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.
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.
Freezer & Cold Storage Calibration Service Areas — Onsite Nationwide
Femto Scientific provides onsite refrigerator, freezer, ultra-low, and cryogenic storage calibration across major pharmaceutical, biotechnology, clinical, and biorepository markets in the United States. Our primary service concentration is in the northeastern U.S., with nationwide coverage through our partner service network.
- New York City, New York (NY) – Manhattan
- Somerset, New Jersey (NJ) – Headquarters
- Boston, Massachusetts (MA)
- Cambridge, Massachusetts (MA)
- Philadelphia, Pennsylvania (PA)
- Baltimore, Maryland (MD)
- Bethesda / Rockville, Maryland (MD)
- New Haven, Connecticut (CT)
- Hartford, Connecticut (CT)
- Providence, Rhode Island (RI)
- Newark, Delaware (DE)
- Manchester, New Hampshire (NH)
- Rochester, New York (NY)
- Richmond, Virginia (VA)
- Durham / Research Triangle, NC
- Charlotte, North Carolina (NC)
- San Diego, California (CA)
- San Francisco Bay Area, California (CA)
- Los Angeles, California (CA)
- Denver, Colorado (CO)
- Houston, Texas (TX)
- Phoenix, Arizona (AZ)
- St. Louis, Missouri (MO)
- Cincinnati, Ohio (OH)
- Cleveland, Ohio (OH)
- Indianapolis, Indiana (IN)
On-site cold storage calibration is available at any U.S. laboratory location. Contact us to confirm scheduling availability for your location and to request a service quote.