Bio Calibration Company has the capabilities that highly regulated laboratories in need of calibration services require.
Along with general FDA requirements, BCC’s Regulated Pipette Service offers our customers the service level needed to meet the following standards:
As our highest-level service offering, we can customize the service to your exact specifications, including sample data, uncertainty reporting, custom test points, custom certificate of calibration, custom calibration labeling, integration with your laboratories, and additional documentation.
With options available for both On-Site and Ship-In Services, we offer the flexibility required to service your laboratory’s equipment without affecting production. We understand that making sure your pipettes are properly serviced can be stressful, especially when there are several requirements and regulations you must abide by. So let us take the stress out of maintaining your pipettes with our Regulated Pipette Service.
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Pharmaceutical, biotech, medical device and contract laboratories working under GMP, GLP or other GxP rules need pipette calibration records that stand up to audits and investigations. Regulated Level is our highest level of pipette calibration: every pipette receives an ISO/IEC 17025:2017 accredited certificate of calibration with measurement uncertainty, as-found and as-left data, and 21 CFR Part 11 compliant electronic signatures.
Every level also includes full-range calibration, preventive maintenance with seal replacement, a leak test, a calibration label and a one-year calibration warranty. As-found data shows whether a pipette was within tolerance before service, which supports your impact assessment if a pipette is found out of tolerance.
We can follow your existing calibration SOPs, test points, acceptance criteria and certificate format, or help you write them. Certificates, labels and service history are available any time in our customer portal, and we can add ELN barcodes to certificates and labels. See our pipette calibration certificates and reports.
Same-day, on-site pipette calibration is available for regulated laboratories in New Jersey, Philadelphia and Southeastern Pennsylvania, Delaware, Maryland, New York, Connecticut and Massachusetts, so your pipettes never leave your facility. Ship-in pipette calibration at our ISO/IEC 17025:2017 accredited cleanroom laboratory has standard turnaround within 72 hours of receipt, with 24-hour expedited service available.