Industry
Calibration for Biotech & Pharmaceutical Facilities
GMP facilities run on measurement, and the instruments that matter most are often the smallest ones. From pipettes calibrated to ISO 8655 — gravimetric and photometric — to balances calibrated in a mass laboratory held to ±0.5 °C, we support the daily metrology load of biotech and pharmaceutical operations with audit-ready data.
Standards & regimes we support
- FDA 21 CFR Part 211
- GMP / GxP
- USP
- ISO 8655
- Data integrity (ALCOA+)
Pipettes and balances, done properly
Pipettes are the highest-volume calibration item in most life-science labs and the easiest to get wrong. We calibrate to ISO 8655 using both gravimetric and photometric methods, reporting the data your quality system needs rather than a bare conformance statement. Because pipettes ship well, this is also one of the most common mail-in items from outside Southern California.
Balance calibration runs in a dedicated mass laboratory on four Mettler mass comparators, with the room held to ±0.5 °C and ±5 %RH during calibration and each weighing cavity independently monitored. We are accredited for ASTM and OIML Class 1 weights up to 25 kg — which is what lets us calibrate analytical balances with adequate margin rather than marginal ratios.
The cold chain and controlled environments
Data loggers and environmental monitoring instruments are the witnesses of your storage compliance: if a logger reads wrong, the entire record of "product stayed in spec" is wrong with it. We calibrate loggers, temperature and humidity instruments against traceable references, and map chambers, refrigerators, freezers, incubators, and ovens where they sit.
For 21 CFR Part 211 facilities specifically, the calibration expectations are explicit about records and about equipment being suitable for its intended use. Our guide walks through what that means in practice.
- ISO 8655 pipette calibration (gravimetric and photometric)
- Analytical and precision balances; ASTM / OIML Class 1 weights to 25 kg
- Temperature and humidity instruments
- Data loggers for cold chain and storage monitoring
- Stability chamber, freezer, and incubator mapping
On-site support and GMP-trained technicians
GMP-trained process technicians are available for on-site work and staffing placements, and our process-troubleshooting services help resolve deviations before they turn into findings. On-site scheduling generally requires three to four weeks of lead time, with after-hours and weekend options for emergencies.
Services biotech & pharma customers use most
Biotech & Pharma calibration FAQs
Do you calibrate pipettes to ISO 8655?
Yes — gravimetric and photometric pipette calibration under A2LA ISO/IEC 17025 accreditation, with full data reported. Pipettes are also a common mail-in item for customers outside Southern California.
What weight classes can you calibrate?
We are accredited for ASTM and OIML Class 1 weights up to 25 kg, calibrated on Mettler mass comparators in a mass lab held to ±0.5 °C and ±5 %RH during calibration.
Do you support 21 CFR Part 211 requirements?
Our certificates provide the traceability, data, and uncertainty that Part 211 calibration records rely on. See our 21 CFR Part 211 guide for a walkthrough — and consult your own quality/regulatory team for interpretation specific to your filings.
Other industries we serve
Calibration built for biotech & pharma.
Send your equipment list and the compliance regimes your customers reference — we'll come back with scope confirmation, pricing, and turnaround.