Wednesday, June 24, 2009

Putting Paper in the Past

An environmental sampling process that employs technology, ensures cleanroom efficiency and security.

Today’s industry standard for collecting and recording the environmental monitoring (EM) process is paper. This paper-based method, which, for the most part, has not varied much since its inception in the late 1970s, can be time consuming for everyone involved, from the technician to the supervisor, and additionally has the potential for multiple errors introduced inadvertently at any step. Consider the popular grade school game “telephone.” One person starts a story that is continually twisted as it transfers from person-to-person until the last individual receives it and shares a totally different story from what was originally told. This misunderstanding and twisting of facts is not exclusive to verbal transmission of stories, as this can also be initiated by people’s handwriting and is often seen in the healthcare as well as the microbiology industries. What a technician writes on the media container or test worksheet in the lab may be misinterpreted by the next person to handle the document or sample. This misinterpretation that occurs during EM data collection, especially when it is a paperbased process, leads to significant recording errors that require time-consuming, labor-intensive corrective action procedures subsequently increasing overtime and lowering productivity.

Realizing the advantages afforded by wireless technology, the microbiology industry is spurring a shift to put paper in the past. A significant investment is being made in information technology solutions to move from paper-based systems to automated-data collection, management, and reporting. Regulatory agencies are encouraging the use of computer- based systems. According to the Parenteral Drug Association (PDA), the recommended procedure to collect data is to utilize a computer-based system for the following reasons:

• “Based on the large number of samples tested by a given facility, a computer-based data tracking system is recommended.”1

• “A manual data entry or image scanner system with advantages of speed and accuracy can be used to populate tables.”1

With new regulations emerging and the significant costs associated with paper-based data collection and recordkeeping, there is increasing demand to improve the efficiency and accuracy of quality control (QC) operations. In reaction to this demand, manufacturers supporting EM testing are beginning to integrate new intuitive wireless technologies into their product portfolios, such as barcode labeling, wireless communications, and remote control operations, for easy integration with EM data-management systems. The following examines how these new applications are addressing recently introduced regulations and helping the industry take full advantage of its information technology investments by automating the EM process from start to finish. CURRENT

Today, the majority of EM processes require the technician to document every step in the process on paper, including sample location, date, time, lot numbers (in the case of plated media or strips), and other infor mation directly on the container. Other factors that need to be noted by the technician include “collection site, date and time of collection, person collecting the sample, current activity at the time of sampling, the media type if appropriate, any deviations of the plan.”2 Given the amount of information required, this becomes a very time-consuming process especially when recorded manually according to ISO14698-1.2.

Once samples have been taken and data recorded, supervisors must review the paper records for accuracy and approve the documents. Then the information may be entered into a database system which again must be reviewed and approved by management. This doubles the amount of time devoted to handling, recording, and approving EM information.

In the case of surface, employee, and active air sampling, the media used must be linked to the corresponding paperwork to ensure accurate result interpretation and record keeping by the microbiology lab personnel. Barcodes are often generated and placed on the media to assist with proper identification, but this process still leaves the potential for error open for the following reasons:

  • the technician deviates from the established workflow plan
  • the barcode interferes with result interpretation.

The analysis step in the QC process also requires that critical information be included on the test report according to ISO14698-1.2:

Type of sample, method(s) used, the number and title of the standard, collection device used, sampling site, type of activity underway at the time of sampling including occupancy state, number of persons within the sampling ar ea, sampling date and time of sampling, sampling duration, time of examination of samples, conditions and duration of incubation, test results from the examination of the collected samples after initial and final reading, when quantitative tests have been perfor med the results expr ess using appropriate SI units, description of the isolate, name of the organization responsible for the test report and date of completion of the test, name and signature of the individual( s) responsible for performing the test.3

With all the information required, it is easy to see how one could write down or copy the wrong information throughout this extensive and cumbersome paper-based process.

Instrumentation manufacturers have taken the first step in improving the paper-based process by incorporating new technology into the instrumentation such as data storage to eliminate the need for tedious paper records. Also, instrumentation is now being equipped with wireless data transfer so data can be sent and received either to a PC or scanner. Instrumentation is also being equipped with safety features to prevent the user from changing any settings, which will help prevent any deviations from the sample process. If any changes need to be made to the instrumentation, it would need to be facilitated by the supervisor and all changes would be tracked with a software program and easily recalled later for review, if and when needed. Similarly, media manufacturers have also started barcoding its media, which will help prevent mix-ups with labeling or using the wrong media during a sample. One media manufacturer has even taken barcoding one step further by using two-dimensional data matrix codes (DMC) on their media. The DMC has features such as error checking so if part of the label has been covered up or destroyed it can still be read. The DMC codes also allow the labels to be smaller than a barcode and even contain more information.

In using the new EM process, paper will be eliminated and automated information technology embraced. There will still be a set of steps the user must take to ensure the accuracy of the sample being taken, however, the chance of errors will be greatly reduced because of having barcoding already in place.

  1. Scan the media being used in the sample. The media-ID information recorded in the scan may include the media being used, lot number, expiration date, and sample ID.
  2. The technician will then scan his or her user-ID, which may include name and employee number.
  3. The next scan will be the location-ID, which may include the room and sample point in the room. Along with this information, the facility can also scan in user defined fields, what is being manufactured, if the room is at rest or in use at the time of the sample, or any other pertinent details according to the standard operating procedure (SOP).
  4. Once all of the information is recorded in the scanner, it may then be transferred wirelessly to the viable air sampler which already contains more required information. The data in the sampler may include the calibration expiration date, serial number, and volume of air to be sampled.
  5. Now that all of the required data has been transferred to the viable air sampler, the sample can be taken.

The steps listed above are repeated for all of the sample locations in the room. The last step in the sampling process is to wirelessly transfer all of the sample data to the PC which is saved in a secure database.

The media can now be incubated according to the facility SOP. Once this is complete, the microbiologist can easily recall all of the information stored in the database. To access the data, the microbiologist will scan the barcode on the media and the record will automatically appear according to the specific identifier of the media. The results can be entered into the record with comments and then saved. This step is repeated for all the media samples taken. Once all of the results are entered, the supervisor can verify and release the record so it may not be altered. Also, if more detailed analysis is needed, the facility can easily integrate this new software with an existing Laboratory Information Management System (LIMS) system.

The same can be also said for media being used without an air sampling instrument. Media that has barcodes from the manufacturer can also be used independently with a scanner and software.

So, in cases where media is used on its own, this new technology can also be leveraged. According to a leading manufacturer of plated media:

  • “…the user no longer needs to carry out additional procedures such as labeling or inscribing plates. This leads to greater GMP compliance of the documentation of the used nutrient media as well as to increased process safety as far as secondary contamination is concerned”4
  • “There is no such risk when it comes to nutrient media with plastic labels, which means that the danger of data loss or mix-ups is considerable reduced.”4

Specific companies have their own specialties and are utilizing one another’s strengths to make the EM sampling plan state-of-the-art. For the most part, the EM sampling plan has been divided into instrumentation, media, and software — primarily LIMS. Today, there is a team effort to combine all or use a combination of these components together. As stated before, the instrumentation can be equipped with data storage and wireless technology to send and receive data to eliminate the need for recording information on paper. Along the same lines, media is now being barcoded from the manufacturer to eliminate another step in the process. Now, if a complete cleanroom computer system is integrated with the instrumentation and media to include sampling plans, instructions, and trending, all steps can be computerized and for the most part completed during the sampling process. This new process will surely be to the benefit of the manufacturer for its enormous time savings. Not to mention, receiving the results of the sampling much faster and catching any problems before product is shipped saves the manufacturer from potential product recalls and possible lawsuits.

Instrumentation, media, and software companies are now redefining the EM sampling process with “Instrumentation Systems” instead of having separate pieces to complete the EM sampling puzzle. The new parts of the puzzle include instrumentation with data storage and wireless technology, media which have been barcoded during the manufacturing process, barcode scanners to read and transmit data, and computer software that tie it all together. This new partnership between companies will create a seamless transition to make paper-based EM a process of the past.


  1. J. Moldenhauer. Fundamentals of Environmental Monitoring Program – Technical Report No.13 (Revised) Volume 55 No.5 page 9
  2. Cleanrooms and associated controlled environments, Biocontamination control – ISO/DIS 14698-1.2 section 5.3.7
  3. Cleanrooms and associated controlled environments, Biocontamination control – ISO/DIS 14698-1.2 section 10
  4. M. Stein, heipha Dr. Muller GmbH, “Increasing process safety and GMP compliance through the use of barcode ready-to-use nutrient media,” Reinraumtechnik.

No comments: