Biopharmaceutical environmental monitoring is a labor-intensive, time-consuming effort required by major regulatory agencies all over the globe. Pharmaceutical companies growing their production capacity have seen an explosion in the monitoring data produced, and the work which is needed to collect, record and interpret them.
Beckman Coulter specializes in manufacturing instruments which optimize workflow efficiencies, the MET ONE 3400 portable air particle counter is one of them.
Innovative software and hardware solutions decrease implementation complexity while providing confidence that the data required have been collected, recorded, and made readily available to the environmental monitoring team.
Failure is not an option
Biopharmaceutical manufacturing of parenterally administered, aseptically produced, products must be carried out in an environment free of bacterial or viral contaminants in order to ensure safety and quality.
A thoughtfully designed and well-executed environmental monitoring program tests the controls used to maintain the cleanroom to the Good Manufacturing Practices standards (e.g., CGMP1 , EU-GMP2 , and PIC/S3 ) required. To verify they are being performed consistently, regulatory agencies will audit these programs.
Failure to execute these programs, by losing data records or missing locations, can result in scrapped product or an audit finding, like an FDA 483 letter, which can result in closure of the manufacturing plant.
Managers will try to identify a root cause upon discovery of these failures. An examination of the process will usually highlight these failure points:
- Failure to take samples from all required locations
- Failure to carry out the defined Standard Operating Procedure (SOP)
- Paper records are lost during the process of photocopying or scanning (to avoid fading)
- Manual transcription errors when entering data points into other electronic systems (e.g., LIMS or Excel)
- Failure to configure the counter to take the air volume needed
- Original paper records have faded over time
Often, these failures are attributed to user error. Corrective action for user error usually entails more training or labor-intensive quality checks; yet, neither solution deals with the error-prone, repetitive processes that have been established.
The only proven ways to decrease the likelihood of user errors in the system are automation and instrument-based software assistance.
Following FDA guidelines while using less paper
Data integrity failure is one of the leading causes for FDA audit findings. In order to help the pharmaceutical industry fully comply with CGMP guidance the US FDA has published clarifying guidelines regarding data integrity4. In their draft recommendations, the FDA states:
For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
The Simply Paperless system for the MET ONE 3400 series of portable air particle counters is designed to provide confidence in data integrity when employed for environmental monitoring.
The MET ONE 3400 possesses a number of mechanisms to ensure data are attributable. It has a password protected login for all operations once configured, meaning all data are attributable to a specific user.
In the MET ONE 3400 locations with full alphanumeric naming can be configured, clearly associating a sample with a location. Lastly, to clearly identify when the sample was taken, every sample is recorded with a time and date.
The utilization of electronic data recording that produces a text-based PDF, inherently improves legibility of records. The MET ONE 3400 includes a comment feature that enables users to add comments to each record, and results may be exported as PDF or XML, which is compatible with SGML.
The FDA recommends submitting copies of electronic records in PDF, XML, or SGML formats, to name a few.5 The MET ONE 3400 produces a secure PDF For added assurance, to prevent unauthorized data altering or tampering.
Building the data management and recording system straight into the MET ONE 3400 instrument ensures data is contemporaneously recorded. Reports are created and available for export via USB thumb drive or to a network via FTP immediately after the test.
Employing these data transfer mechanisms enhances the response time to data by eradicating any delays from manually transcribing data into another system. Utilizing an original, digitally recorded record avoids multiple workflow steps where data can be lost.
Over time, thermally printed paper records fade and for long life, must be gathered and photocopied. The photocopies are then entered manually into other tracking systems. Each step creates chances for paper records to be misplaced or mistyped into other databases.
Utilizing the MET ONE 3400 Simply Paperless system ensures all records are the originals which were created and generated within the instrument itself. Of all these data integrity requirements, accuracy is the main aim.
Workflow efficiencies realized with MET ONE 3400’s Simply Paperless system increase accuracy by minimizing the chance for human error while eliminating manual configuration, calculation or data entry.
A workflow review can disclose multiple touchpoints where data integrity failures could result in an audit finding or a production lot rejection. MET ONE 3400’s Simply Paperless feature considers each of these failure points.
- Paper records are lost during photocopying or scanning (to avoid fading)
- No paper records are used, avoiding the need for photocopying/scanning and eliminating the possibility of their loss.
- Failure to perform the defined Standard Operating Procedure (SOP)
- Locations are pre-programmed into groups.
- Users see only the SOP(s) and location groups for which they are responsible.
- Failure to configure the counter to take the air volume required
- Locations are preconfigured with the correct timing to achieve the air volume required.
- Original paper records have faded over time
- Secure PDFs of the data are stored on a USB thumb drive or uploaded to a file server.
- Failure to take samples from all the locations required
- All locations for each SOP are grouped together in the order in which they should be taken.
- Users are only required to select the Next button to cycle through all locations.
- Manual transcription errors when entering data points into other electronic systems (e.g., Excel or LIMS)
- Outside data processing tools can read data straight from a secure PDF, XML or text format. Results may be processed or stored for later analysis, recall or trending.
By reducing the possibility of human error and eliminating work steps whenever possible The MET ONE 3400 is designed to optimize workflow efficiencies.
Using the MET ONE 3400 Simply Paperless portable air particle counter simplifies compliance with global regulatory standards and decreases the possibility of an audit finding because of data integrity issues. The result is confidence that the facility and its data are compliant.
Chart. Five manual touchpoints increase the chances of data integrity errors in a typical routine environmental monitoring program. Source: Beckman Coulter Life Sciences
- Ensure use of most current SOP
- Read and understand SOP
- Manually type each sample location name
Manually configure counter
- Sample time
- Number of samples
- Results averaging
- Correct multiplier for m3
- Manually transcribe results
- Food and Drug Administration. Guidance for industry. Sterile drug products produced by aseptic processing – current good manufacturing practice, 2004. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Office of Regulatory affairs (ORA) Division of Drug Information, HFD-240 Center for Drug Evaluation and Research, Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 USA.
- European Commission. EudraLex. The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice. Medicinal products for human and veterinary use, Annex 1: Manufacture of Sterile Medicinal Products, 25th November 2008. European Commission Enterprise and Industry Directorate-General, B-1049 Bruxelles/Europese Commissie, B-1049 Brussel – Belgium.
- Pharmaceutical Inspection Co-operation Scheme, PIC/S Guide To Good Manufacturing Practice for Medicinal Products, 1st January 2017, PIC/S Secretariat 14, rue du Roveray CH - 1207 Geneva Switzerland.
- U.S. Department of Health and Human Services Food and Drug Administration Data Integrity and Compliance With CGMP Guidance for Industry. April 2016. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Veterinary Medicine (CVM).
- U.S. Department of Health and Human Services Food and Drug Administration Guidance for Industry, Part 11, Electronic Records; Electronic Signatures — Scope and Application. August 2003. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Office of Regulatory affairs (ORA) Division of Drug Information, HFD-240 Center for Drug Evaluation and Research, Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 USA.
About Beckman Coulter Life Sciences
Beckman Coulter Life Sciences is dedicated to empowering discovery and scientific breakthroughs. The company’s global leadership and world-class service and support delivers sophisticated instrument systems, reagents and services to life science researchers in academic and commercial laboratories, enabling new discoveries in biology-based research and development.
A leader in centrifugation and flow cytometry, Beckman Coulter has long been an innovator in particle characterization and laboratory automation, and its products are used at the forefront of important areas of investigation, including genomics and proteomics.
Primary activity / Product lines
- Flow Cytometry
- Particle Counting and Characterization
- Liquid Handling and Robotics
- Nucleic Acid Sample Preparation
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