Going Paperless Save Time and Improve Data Integrity: Cleanroom Environmental Monitoring

Transcription

1 Going Paperless Save Time and Improve Data Integrity: Cleanroom Environmental Monitoring New Paperless particle counter technology and new ISO standard for calibration save time and improve confidence in quality. By Tony Harrison, UK Subject Matter Expert to ISO Technical Committee 209 Working Group 01, January 2013

2 Going Paperless Save Time and Improve Data Integrity: Cleanroom Environmental Monitoring New Paperless particle counter technology and new ISO standard for calibration save time and improve confidence in quality. By Tony Harrison, UK Subject Matter Expert to ISO Technical Committee 209 Working Group 01, January 2013 Introduction The intensely manual practices of cleanroom classification and routine monitoring are time-consuming and prone to data errors. Particle counter performance and accuracy can vary widely, leading to inaccurate particle counting data. 1. Typical Practice Challenges: Air particle counts are sampled at various locations in the cleanroom resulting in varied data readings due to complexed monitoring programs and devices Cleanroom operator uses inconsistent data which can cause error leading to inaccurate counting Highlights New Paperless particle counter technology can save up to 20% of the time spent on cleanroom environmental monitoring programs Going Paperless removes error-prone manual data collection and storage and meets the requirements of EU GMP Annex 11 and FDA 21CFR part 11 for data integrity 2. Manual data transcriptions for trending: 3. Paper reports: Not 21 CFR part 11, or EU GMP Annex 11 compliant Thermal printer paper = fades with time Transcription errors = possible product quality issues Additional time wasted preparing data by Data not secure and cannot be used for long term scanning thermal paper and making copies storage/batch release for digital record storage New ISO will reference ISO for particle counter calibration, delivering improved counter accuracy and increased confidence in particle counting results Fig 1 Potential data errors from cleanroom particle counting Cleanrooms as a system Cleanrooms may be considered as a system, with people typically the largest source of airborne particulate contamination and the cleanroom s air handling system designed to remove this contamination. The balance between incoming contamination and the removal of contamination is designed to deliver the required air quality of the cleanroom system to meet the requirements of the processes.

3 Air Handling Contamination Source Cleanroom Contamination Removal People Fig 2 Cleanrooms as a system Why is data integrity important? Routine monitoring data can be trended to detect any deviations or tendency to drift towards an out-of-specification situation (OOS) that may threaten product quality. However, if the data integrity cannot be relied upon, either through frequent manual data transcription errors, or through poor particle counter-to-counter measurement issues, then the benefit of data trending can be called into question. Improvements in data integrity are encouraged by the regulatory expectations of EU GMP Annex 11 and the FDA s 21 CFR part 11 documents, driving users to seek more robust and secure methods of collecting and storing portable particle counter data. Manual data transcription from particle counter paper print-outs into data trending and archiving systems is no-longer an option. Poor data integrity can lead to false data points that seem to indicate an OOS event. The resulting root-cause investigation may not be able to identify that there had been a transcription error or that the error was due to poor particle counter performance and the investigation may be left unresolved. Counts/m 3 Transcription error leads to false OOS Counter variance leads to false OOS Compliance Limit Actual High Limit Actual Low Limit time Fig 3 Poor data and transcription errors can lead to false 00S results and unresolved root-cause investigations

4 Barrier to energy savings The cleanroom air handling systems are typically one of the top three energy consumers on a pharmaceutical production site 1. Many cleanroom users are starting to look for potential energy savings from their cleanrooms to help meet carbon footprint reduction targets and also to help reduce operating overhead costs. One area for energy savings under consideration is controlling the air handling systems to adjust cleanrooms air change rates to match the varying contamination loading, especially in cleanrooms that were over-engineered in their original design. However, if the cleanroom monitoring data cannot be relied on, then these improvements in energy savings are difficult to realize with any confidence that quality will be maintained. Equally, the maximum energy savings may not be realized, leaving cleanroom owners with excessive margins of air handling system over-performance and energy consumption due to lack of ability to get to the real performance data. Counts/m 3 Transcription error leads to false maximum Counter variance leads to false maximum Missed opportunity for air change reductions and energy savings Reported maximum contamination Actual maximum contamination time Fig 4 Poor data and transcription errors prevent energy savings from being maximized Barrier to energy savings In order to improve confidence in counter-to-counter performance, the revised ISO document planned for publication in 2014 will provide a reference to ISO , Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces 3, to direct the reader to a standardized test method for particle counter calibration. ISO was originally published in 2007 and first appeared in the draft of the revised ISO published in December By the time the new ISO document is released in 2014, industries using portable particle counters will have had seven years notice to comply with ISO calibration method and to upgrade any non-compliant particle counters. Before the publication of ISO there were no internationally-recognized calibration standards for airborne particle counters resulting in widely varying performance from particle counting instrumentation. Since 2007, most international manufacturers of particle counters designed for use in ISO applications have improved their particle counter designs where necessary so that they can now meet the more demanding expectations of this new calibration standard. Cleanroom users can now achieve a much higher level of confidence that their cleanrooms are delivering the required level of quality controlled environment for their processes.

5 Complex Environmental Monitoring Programs In applications where large numbers of sampling locations with different sampling configurations are involved, manual configuration of the particle counter set-up at each location can lead to errors and the resultant unreliable data. Technician B Log-on A Suites 1 to 4 Log-on B Suites 5 to 8 Fig 5 Manual configuration for sample locations can be eliminated using advanced counter technology Advances in particle counter technology now allow the user to select the correct pre-programmed sub-set of sampling recipes and location labels through user log-on. So an operator carrying out a routine monitoring program can simply log-on to the particle counter to be offered only the sub-set of the entire pre-programmed recipe library pertinent to their daily routine. Equally, a cleanroom classifier can utilize this functionality to enter a cleanroom suite dedicated log-on to be offered the appropriate sub-set of the entire pre-programmed recipe library pertinent to that specific cleanroom suite. Paper trails and manual data transfer Most portable particle counters used for cleanroom classification or routine monitoring programs provide particle count data reports via on-board thermal printers. Cleanroom classifiers and those people carrying out routine environmental monitoring programs then have to tear off this paper and transfer it to a secure format in preparation for the batch release file and for archiving. However, thermal paper print-outs are not stable and will become totally illegible over time. So the particle counter operator then has to stick the print-outs onto paper and scan them in, whether as a photocopy, or into a PDF file. In order to then transfer the data from the paper print-outs into the data archiving/data trending system, the particle counter operator then has to manually type the data in. Each of these steps is time-consuming and error-prone; with some particle counter user teams reporting that they spend up to 20% of their working day photocopying and manually entering data.

6 Activity 1: Result: Tear and cut printout Wasted time & error-prone Workflow Item: Activity 2: Result: Activity 3: Result: Scan paper print-out Wasted time Manual data transcription Wasted time & error-prone Sampling Time Photocopying and entry to spreadsheet software (Excel ) Report writing Fig 6 Manual processes associated with particle coiunters can take up to 20% of the working day Going Paperless Save time and improve confidence in data New advances in particle counter technology have allowed the elimination of paper print-outs and manual data entry. Instead the new range of Paperless particle counters export the particle count data in secure PDF format for electronic batch release files and archiving and simultaneously in a format ready for Excel so that the data can be trended.

7 Data exported direct to Excel for trending No manual transcription errors EM program pre-configured and password protected no counter set-up errors ISO compliant counters accurate, repeatable results Data exported direct to secure PDF for electronic batch release file Secure for long-term storage Fig 7 Paperless technology resolves data integrity issues and saves time Going Paperless removes the need for manual paper processing and data transcription, freeing up to 20% of operator time, while at the same time meeting the requirements of EU GMP Annex 11 and FDA 21CFR part 11for data integrity. As an added bonus, data transcription errors are eliminated and data can be reliably used for trending. Conclusion A recent FDA warning letter highlighted large gaps in environmental monitoring data for a manufacturer of sterile drug product. Paperless particle counter technology removes manual data transcription errors and can save up to 20% operator time, leading to increased efficiencies and cost savings, while helping to eliminate data gaps. Particle counter accuracy and counter-to-counter reproducibility through ISO calibration improves confidence in particle counter trending data. Combined, Paperless technology and ISO calibration deliver overhead efficiencies, improved data quality control and support initiatives to reduce energy consumption and carbon footprint.

8 Bibliography 1. Energy Efficiency Improvement and Cost Saving Opportunities for the Pharmaceutical Industry. Energy Analysis Department, Environmental Energy Technologies Division, Ernest Orlando Lawrence Berkeley National Laboratory, University of California, Berkeley, California March Ref: LBNL Revision. 2. ISO :1999(E) Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness May 1, International Organization for Standardization Case Postale 56, CH-1211 Genève 20, Switzerland. 3. ISO Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces International Organization for Standardization Case Postale 56, CH-1211 Genève 20, Switzerland. About the author Tony Harrison is a subject matter expert to the UK British Standards Institute (BSI) cleanroom mirror group and one of the UK subject matter experts on ISO Technical Committee 209 Working Group 01 tasked with revising ISO and -2. He is also Convenor of ISO Technical Committee 209 Working Group 02 tasked with the revision of ISO and -2 for the classification of the cleanroom environment by microbiological cleanliness. Tony is employed by Hach Company as a Compliance and Applications Specialist.