In recent years, pharmaceutical cleanrooms have undergone a lot of changes and these can be attributed to industry dynamics in the form of acquisitions, mergers, and drug patent-cliffs, forcing production facilities to conform to the U.S. Food and Drug Administration (FDA) policies.
The FDA requirement for the monitoring of non-viable particle counts is a constant element for Cleanrooms. This is to ensure that the production of injectable drugs is carried out a in a safe and uncontaminated environment. This article describes the complexities involved in the manual management of particle count data with respect to cleanrooms, and provides guidance on how to apply a more efficient method to offset change control barriers.
Current Practice Challenges
In the pharmaceutical manufacturing industry, environmental monitoring (EM) managers, QA/QC professionals, and production managers alike generally adopt similar methods for particle monitoring. In this process, portable air particle counters, fitted with stainless steel iso-kinetic probes, are mounted on a cart and taken around cleanrooms to sample the air and determine the level of particle contamination.
Particle measurement is a routine task, with sampling of a pre-determined point of measurement done at standard intervals. To this end, sampling recipes and location selection depend on the area classification of each cleanroom. In general, both compiling and managing of particle counting data at each sampling environment can be summed up as follows:
- Use a portable air particle counter to calculate air particle counts at the sampling site
- Use the integrated thermal paper printer in the particle counter to print the data
- Assess the print-out data set to make sure that no alarm conditions exist
- Take out the printer paper from the air particle counter and tape the same to an A4 paper sheet
- Operators of cleanrooms should sign across the print-out and the paper sheet to ensure that the original data adheres to 21 CFR part 11 data security specifications
- When exiting the cleanroom, operators must take the print-out attached to the paper sheet and scan the same either in the form of a PDF file or hard copy
- Manually enter the print-out data into the LIMS or Excel spreadsheet for storing the data set
Figures 1 shows a standard particle counter with built-in thermal printer, and Figure 2 illustrates the current practice.
Figure 1. Typical particle counter
Figure 2. Current practice
The above steps are again performed for each sampling site, in each cleanroom of the facility. Irrespective of the age or size of the facility, most of the particle counter data of the cleanroom is controlled and managed using the above steps. However, these steps can take a significant amount of time in large pharmaceutical facilities.
Managing Particle Counter Data
Many pharmaceutical facilities still continue to manage their particle counting data of cleanrooms using the aforementioned steps. This is because it is not easy to change the existing FDA’s Good Manufacturing Practice (GMP) processes for a number of reasons.
The primary reason is that the FDA had inspected the drug manufacturing process and so far has not raised any compliance gap. In a FDA GMP pharmaceutical production setting, no published standards are available to define these processes. As a result, users must establish a suitable CIP process in line with their process goals.
The secondary reason is that commercially-available particle counting products are not suitable for meeting specific application needs. Most manufacturers of particle counters provide the following product portfolio to pharmaceutical cleanrooms to perform sampling and manage data:
- Solution #1: Portable air particle counter with built-in thermal printer
- Solution #2: Particle counting software developed for use with air particle counters
- Solution #3: Fixed location, on-line remote particle counters, which demand a constant monitoring software suite normally set up on the network. This is called as facility monitoring systems (FMS)
These products come with pros and cons, but nevertheless are still being used in pharmaceutical cleanroom facilities for more than 25 years.
Particle Counting Software
Any software product for that matter brings a new set of risks and imposes significant changes to established and approved cleanroom management processes. This is the major reason as to why operators of pharmaceutical cleanrooms follow the eight steps of manual data management.
Furthermore, due to limited production capacity, manufacturing uptime is very important to realize profitability in pharmaceutical production, and implementation of any change control process in large scale can take a long time to complete and bring the manufacturing process back on track.
Paperless Particle Counter
With the advent of a new, advanced particle counter system in the market, the eight manual steps of managing cleanroom data are now totally eliminated. The new system involves only a slight change to the current cleanroom procedures (SOPs) and does not require any software. Figure 3 shows a portable particle counter without the on-board thermal printer.
Figure 3: Paperless particle counter
Hach Company has developed an advanced yet simple portable air particle counter called the MET ONE 3400 particle counter. The system does not require any external software and instead generates a PDF and a separate EXCEL file written on a single USB memory stick. This USB stick is in turn plugged into the particle counter. The PDF file is secure and similar to paper printouts generated by the thermal printer; also the data is written on an excel record and thus prevents human transcription errors.
Operators of particle counters can easily collect samples throughout the cleanroom and store all their preferred data in the secure electronic form on the USB memory stick. In majority of cases, the environmental monitoring manager or QC department will require a slight change to SOPs, which can be accomplished easily.
The MET ONE 3400 paperless air particle counter helps in overcoming the complexities of manual management of cleanroom particle count data. This unique system is easy to use, does not require any external software, and streamlines the entire cleanroom data management.
About Beckman Coulter
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than a quarter of a million Beckman Coulter instruments operate in laboratories around the world, supplying critical information for improving patient health and reducing the cost of care.
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