White Paper- Calibration in the Pharmaceutical Industry

Product catalog summary

Introduction
The pharmaceutical industry is critical as it directly impacts the health of billions. Calibration in this sector ensures the integrity of processes and the safety of products. Regulations are stringent to prevent errors that could affect public health.

Pharmaceutical Operations
Pharmaceutical manufacturing often involves batch processes with numerous pressure and temperature measurements. Proper calibration of instruments is crucial for product quality. Documentation of calibration is essential for verifying process integrity and identifying errors.

Manual Documentation
Traditionally, calibration involved paper documentation, which was cumbersome and error-prone. Regulations require detailed records, including calibration history, error limits, and technician qualifications.

Electronic Documentation
Electronic systems, like Beamex's CMX software, reduce errors and improve efficiency by automating documentation. These systems comply with 21 CFR Parts 11 and 211, ensuring secure and traceable records.

Calibration Solutions
Beamex offers solutions like the MC5 Multifunction Calibrator and CMX software, designed for rugged environments and hazardous locations. These tools facilitate efficient calibration management and integration with systems like SAP/R3.

Summary
Automated electronic calibration saves time and reduces errors. Proper calibration is vital for pharmaceutical safety and efficacy. Beamex products and services, including installation and validation, support compliance with industry regulations.

Catalog excerpts

White Paper- Calibration in the Pharmaceutical Industry-1

EN_FICHE DIVA LClean-21x29,7 table.main {} tr.row {} td.cell {} div.block {} div.paragraph {} .font0 { font:6.00pt "Arial", sans-serif; } .font1 { font:7.00pt "Arial", sans-serif; } .font2 { font:17.00pt "Arial", sans-serif; } .font3 { font:27.00pt "Arial", sans-serif; } .font4 { font:32.00pt "Arial", sans-serif; } .font5 { font:35.00pt "Arial", sans-serif; } Beamex Calibration White Pape [email protected] Calibration in the pharmaceutical industry beamex World-class calibration solutions

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White Paper- Calibration in the Pharmaceutical Industry-2

EN_FICHE DIVA LClean-21x29,7 table.main {} tr.row {} td.cell {} div.block {} div.paragraph {} .font0 { font:8.00pt "Arial", sans-serif; } .font1 { font:9.00pt "Arial", sans-serif; } .font2 { font:11.00pt "Arial", sans-serif; } .font3 { font:13.00pt "Arial", sans-serif; } .font4 { font:35.00pt "Arial", sans-serif; } .font5 { font:46.00pt "Microsoft Sans Serif", sans-serif; } .font6 { font:9.00pt "Times New Roman", serif; } BEAMEX Calibration White Paper Calibration in the pharmaceutical industry Pharmaceutical Oprations T he pharmaceutical industry produces products that directiy affect the life...

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White Paper- Calibration in the Pharmaceutical Industry-3

EN_FICHE DIVA LClean-21x29,7 table.main {} tr.row {} td.cell {} div.block {} div.paragraph {} .font0 { font:8.00pt "Arial", sans-serif; } .font1 { font:9.00pt "Arial", sans-serif; } .font2 { font:11.00pt "Arial", sans-serif; } .font3 { font:13.00pt "Arial", sans-serif; } .font4 { font:9.00pt "Times New Roman", serif; } BEAMEX Calibration White Paper conformance with the rgulations, paper documentation was both cumbersome and prone to human error. Simply put, it is not difficult to make mistakes when calculations are performed manually and most dates, times, measurements, calculation results,...

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White Paper- Calibration in the Pharmaceutical Industry-4

EN_FICHE DIVA LClean-21x29,7 table.main {} tr.row {} td.cell {} div.block {} div.paragraph {} .font0 { font:7.00pt "Arial", sans-serif; } .font1 { font:8.00pt "Arial", sans-serif; } .font2 { font:11.00pt "Arial", sans-serif; } .font3 { font:13.00pt "Arial", sans-serif; } .font4 { font:12.00pt "Times New Roman", serif; } BEAMEX Calibration White Paper Print calibration certificate / sticker Dviation Report A Calibration process in a pharmaceutical company with the Beamex calibration system. CMX's change management complies to FDA requirements (21 CFR Part 11 Electronic Records and Electronic Signatures)....

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White Paper- Calibration in the Pharmaceutical Industry-5

EN_FICHE DIVA LClean-21x29,7 table.main {} tr.row {} td.cell {} div.block {} div.paragraph {} .font0 { font:8.00pt "Arial", sans-serif; } .font1 { font:11.00pt "Arial", sans-serif; } .font2 { font:13.00pt "Arial", sans-serif; } .font3 { font:17.00pt "Arial", sans-serif; } .font4 { font:9.00pt "Times New Roman", serif; } BEAMEX Calibration White Paper bench and calibration system for workshops and laboratories, which incorporates the functionality of the MC5 and can measure/generate additional parameters such as precision pressures. The ergonomic design and modular construction allow the user...

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