Biopharmaceutical products that are hygienically produced must be clean and free from viral and bacterial contaminants. An effective environmental monitoring (EM) program can be implemented to evaluate the contamination control strategy. The resulting EM results can be made an integral part of the batch release process.
Routine Environmental Monitoring
Biopharmaceutical manufacturing facilities operate aseptic filling lines that are surrounded by air. This air is usually controlled by using isolators, cleanrooms, RABs, and mini-environments. In order to ensure sterility and quality, these environments are maintained to comply with rigorous conditions specified in Good Manufacturing Practices such as EU-GMP, cGMP, and PIC/s. As per these directives, air particle should be continuously monitored during filling operations, and supporting clean zones should also be routinely monitored, all performed to a controlled standard operating procedure (SOP) driven schedule.
However, in a GMP-compliant pharmaceutical production facility, supervisors, QA/QC managers and EM operators can face a number of problems in maintaining and controlling routine environmental monitoring. This process involves a lot of reporting and verification activities that take significant amount of time. Moreover, large volumes of data are handled manually and are thus prone to operator error. Even if correct methodology is applied, large numbers of paper-printouts have to be checked and scanned for archiving and also need to be transcribed to Excel document for long-term trending.
EM applications in pharmaceutical manufacturing facilities usually involve a number of sampling locations with conflicting sampling recipes. In places where particle counters are handled by multiple operators, manual configuration of the system at each site can lead to potential errors.
The MET ONE 3400 series particle counter has been specifically designed to manage the EM workflow in biopharmaceutical manufacturing facilities. The particle counter is designed to store 999 unique location IDs, with each ID labeled with an alpha-numeric location name. In addition, a unique "Group" function allows sampling recipes to be pre-defined.
Sets of locations can be easily arranged into "areas" which can be controlled as a visual directory tree on the user interface of the system. The sampling workflow can be started only with individual user name and password.
The MET ONE 3400 also enables administrators to associate particular sample recipes with individual users. In turn, particular locations and areas can be associated with the list of recipe groups. This way, operators who perform routine monitoring can easily logon to the instrument and view only the recipes and related sample locations applicable to their workflow. In addition, all the MET ONE 3400 series particle counters can be programmed similarly, enabling operators to logon to any particle counter and perform their individual workflow.
EM managers and administrators can easily maintain multiple instruments that are programmed in the same way. After the first MET ONE 3400 instrument has been programmed with all the recipes, locations, areas, etc, the whole configuration can be replicated to other MET ONE 3400 instruments through a USB memory stick.
MET ONE Simply Paperless Solution
The MET ONE “Simply Paperless” solutions were specifically developed to generate PDF files that would be similar to the PDF pages manually created with paper printouts. Food and Drug Administration (FDA) has proposed that electronic records should be developed using established automated export methods and provided examples such as XML and PDF file formats. The MET ONE 3400s supports both these formats.
The MET ONE 3400 particle counter supports several unique features and allows administrator to configure the method in which the PDF equivalents are produced to replicate the manual tasks of cutting and pasting processes, based upon simple and easy rules.
The particle counter allows location sampling, wherein the instrument is moved from one place to another to run pre-defined sample recipes. This ability streamlines the sampling workflow processes. Operators can also make comments on the PDF versions of paper printouts through the instrument's user interface. Administrators can later configure these comments to be mandatory or optional according to the needs of the existing SOP. Finally, after the workflow, the PDF files can be sent for archiving.
Non-IT professionals may find it difficult to transfer particle count data as Excel and PDF files over a network. For this purpose, the MET ONE 3400 uses an established technology that is simple and easy to use.
The MET ONE paperless workflow and data management systems can help biopharmaceutical manufacturers to save considerable amount of time by preventing errors and the resultant wastage associated with manual environmental monitoring activities.
This information has been sourced, reviewed and adapted from materials provided by Beckman Coulter, Inc. - Particle Characterization.
For more information on this source, please visit Beckman Coulter, Inc. - Particle Size Characterization.