“Validation Study Report Against Various International Standards” Review

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Background of the study

The ultimate responsibility of any food, aerospace, micro-electronics pharmaceutical, or medical device manufacturing company is to maintain the quality and standards in place to guarantee customer/user safety. These companies must ensure that the products and equipment produced are devoid of contaminants that can harm the users since most of these products are used either externally or internally. These contaminants include; dust, airborne germs, outdoor dirt, and tiny micro-organisms. This forms the basis of microbiological monitoring initiatives that are undertaken by the companies themselves to gain the public confidence that their products are safe for use (Dynatec Labs, 2007). The monitoring is implemented through tests that are carried out during production of the products or installation of processes and they are bound by the International Standards that must be followed.

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This paper entails a detailed review of the “Validation study of the Micro-biological Environment of the Production Area for the manufacture of active implantable neurological devices” against the requirements of BS EN ISO 14644 (part 1-7), BS EN ISO 14698, and BS ISO 13485 (about the guidance provided in ISO TR 14696).

A Review of the Validation Study report against various International Standards (BS EN ISO)

BS EN ISO 14644 (Clean-rooms and other associated controlled environments)

These set of standards provide for the requirements of clean-rooms that ensure that air-borne particulate contaminants are maintained at levels that cannot influence the quality of products and processes that are sensitive to such contaminations. The first part of these standards, EN ISO 14644-1, provides for the classification levels that specify the degree of air cleanliness in clean rooms and other controlled environments (EN ISO 14644-1, 1999, p.12). The validation report complies with the principle of this part of air cleanliness. The tests are carried out to follow the requirements of the customers and the suppliers and they are documented as agreed upon by both parties. The report demonstrates that the tests were carried out using calibrated instrumentations followed by the determination of the airborne particle concentration limits. By the provisions of this part, the test results from each clean room and zones were recorded in this report. However, the report does not provide a statement of compliance or non-compliance with the specifications of ISO 14644-1. Other requirements of such a report as provided in EN ISO 14644-1 (1999, p.17) are met in the current case.

The second part of these standards, ISO 14644-2, provides for the “specifications for testing and monitoring to prove continued compliance with the provisions of ISO 14644-1 reviewed as above” (ISO 14644-2, 2000, p.1). These include the factors that are taken into consideration in designing, operating, choosing specifications, and controlling the clean-rooms and other related controlled surroundings (ISO 14644-2, 2000, p.5). These involve re-qualification, testing, and monitoring processes that are carried out either frequently, continuously, or in 6-months, 12-months, and 24-months intervals (ISO 14644-2, 2000, p.7). Since the production clean-room was a newly installed zone, the report does not have to comply with these provisions however, it is indicated that such tests are to be undertaken every month involving 20 sets of such micro-biological monitoring tests.

ISO 14644-3 provides for specifications of the test methods that can be employed in accomplishing other provisions as provided in the previous parts of the ISO 14644 standards (EN ISO 14644-3, 2005, p.v). These are characteristic test methods on the performance of the clean rooms and other controlled places. These rooms are classified into unidirectional and non-unidirectional according to the direction of air flow. They can also be classified into as-built, at-rest, and operational about their state of occupancy during the test (EN ISO 14644-3, 2005, p.1). The report indicates that the only tests that were carried out are; Air-borne microbial count and Recovery methods on working surfaces. The reports do not document the performance of any other methods such as air-flow test, air-pressure difference tests, installed filter system leakage tests, temperature, and humidity uniformity tests among others which would have generated useful data for air cleanliness analysis (EN ISO 14644-3, 2005, pp.9-10). These tests offer for measurements of particles according to size and even time of flight particle size measurements. The other provisions of this part as documented in the (EN ISO 14644-3 (2005, p.11) are fulfilled by the report.

EN ISO 14644-4 provides for the specifications of the design and construction of the clean-rooms and other controlled environments (EN ISO 14644-4, 2001, p.v). These requirements are meant for those involved in the design and the installation of the clean-room facilities. Further, the standards provide for testing and approval requirements that should be performed at the end of the construction and installation of the facilities. The report indicates the general site plan of the facility with a detailed outline of the installed merchandise but it fails to document any such tests as provided by this part of the International Standards. Instructions for performance monitoring are not provided instead instructions on the facility usage are yet to be provided. When adequately followed, these provisions will provide for segregation of clean-rooms and clean zones, control and manipulation of airflow patterns, and documentation of the facility’s performance (EN ISO 14644-4, 2001, pp.9-15).

The fifth part of these standards provides for the most basic requirements governing the operations of clean-room facilities (EN ISO 14644-5, 2004, p.1). The requirements include specification of the operational systems, provision of clean-room clothing, approval of personnel to access the facility, preliminary treatment of the stationary, materials, portable and mobile equipment before their introduction into the facilities, and procedures for cleaning the facility (EN ISO 14644-5, 2004, pp.3-6). The report indicates that such instructions had been given verbally in addition to training them on the same. However, it indicates that no written instructions or procedures were governing the conduct of the operators. The report does not provide for the procedures for assessing the contamination risks, operational risks, and monitoring of clean-room personnel and the corrective actions.

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The sixth part of the ISO 14644 standards provides the meanings of the various terms that are employed in describing the provisions laid down in other parts of the ISO 14644 standards (EN ISO 14644-6, 2007, pp.1). These vocabularies are useful when performing various tests in terms of providing specific measurements and meaning that are to be employed in documenting reports. The current case indicates an extensive utility of such terms in the preparation of the validation study report. Given the various problems encountered during the manufacturing processes such as process sensitivity to contaminants and micro-organisms, operator’s sensitivity to various process raw materials and by-products, and the product sensitivity to various contaminants, it was imperative to look for means for countering these problems. These difficulties have seen the introduction of separative devices that protect by acting as a barrier (EN ISO 14644-7, 2004, p.v). The seventh part of the ISO 14644 standards provides for the specifications of these devices. These devices include; access devices (with robotic or manual operating mechanisms), and transfer devices. These devices undergo periodic or occasional testing to ensure that their performance is maintained. The current case does not comply with these provisions and it does not document any such separative devices.

BS EN ISO 14698-1: Bio-contamination control

These standards provide for the principles and methodology employed in creating clean and controlled environments in the clean-room facilities. Many companies have been employing antimicrobial agents in controlling the contamination of hygiene-sensitive products. However, following the reduced usage of such techniques, the employment of bio-contamination control has become very important (EN ISO 14698-1, 2003, p.v). These provisions are achieved through the process of monitoring, evaluating, and controlling those factors that are perceived to influence the microbiological quality of the products or processes. This can be achieved through two main methods (that is) the HACCP system and FMEA or any other. Monitoring is carried out through sampling and analysis of various variables using methods provided in the part. The samples are then cultured on media, incubated before they can generate valuable data for analysis (EN ISO 14698-1, p.9). Evaluation of the data generated helps in laying down plans for future corrective actions. Finally, the data is interpreted and the results documented. The report complies with all the above provisions except that it fails to provide for any data interpretation and provision of training records.

BS EN ISO 13485: Quality Management Systems for Medical Devices

These standards provide for the requirements of setting up a quality management system for the design, production, installation of the products and processes for the production of medical devices (EN ISO 13485, 2003, p.v). By implementing these standards, an organization stands a chance of meeting the requirements of the customers and the regulatory authority. Moreover, this target can be achieved through the employment of the “Plan-Do-Check-Act” methodology in all the organization’s processes (ISO/TR 14969, 2004, p.6). These systems require the management to; identify the various processes that can be applicable in their respective organizations to achieve quality, determine ways in which the implementations of these processes can be made effective, determine how the processes can be implemented in addition to assessing the interaction between the individual processes, supply the required funds and information required for monitoring and assessment of these processes, monitor, measure and analyze the effectiveness of the implemented processes and finally, implement corrective actions that can guarantee the perceived results (EN ISO 13485, 2003, p.4). The current case complies with the above requirements in many ways except that it does not provide for any proposed processes that can support future quality management systems. It fails also to provide for any future corrective actions that will be taken in guaranteeing quality.

Bio-burden Monitoring

Bio-burden testing is carried out to guarantee the general public that the product offered is free of any micro-organisms. This can be achieved through radiation sterilization validation. This involves processes such as product qualification, maintenance of validation, installation qualification, and process qualification among others (Q & A, n.d.). According to the data generated in this case during microbiological monitoring, the organization would need to carry out thorough installation qualifications to ensure that all the micro-organisms of the working surfaces are eliminated. Additionally, process and product qualification should be done to access the extent of contamination caused by these contaminated working surfaces.


The paper has provided an in-depth review of the validation study report on the microbiological monitoring process for the MLM organization. The review is focused on the major International Standards that govern such processes as microbiological monitoring and bio-burden monitoring. The review covers the degree to which the various standards and provisions have been observed in preparing the report. In addition, the influence of the data generated on the bio-burden testing process has also been reviewed. The report complies with these provisions in many ways except that there are some deficiencies that were evident particularly in the limitation of the methodologies used. Other provisions such as the Federal Standard 209 E and some parts of the ISO 14644 should be taken into consideration in ensuring that the products and processes are devoid of any contamination (Duarte, 2009, p.6).

Reference List

  1. Duarte, R 2009, Environmental monitoring of clean-rooms, DDK scientific, Corp.
  2. Dynatec Labs 2007, An overview of bioburden testing.
  3. EN ISO 14644-1:2003, Clean-rooms and associated controlled environments: bio contamination control, Incorporating Corrigendum No.1, British Standards.
  4. EN ISO 13485:2003, Medical devices: quality management systems, Incorporating Corrigenda June 2007, February 2008 and August 2009, British Standards.
  5. EN ISO 14644-3:2005, Clean-rooms and associated controlled environments: test methods, British Standards.
  6. EN ISO 14644-5:2004, clean-rooms and associated controlled environments: operations, British Standards.
  7. EN ISO 14644-7:2004, clean-rooms and associated controlled environments: separative devices, British Standards,
  8. EN ISO 14644-1:1999, Clean-rooms and associated controlled environments: classification of air cleanliness, Incorporating Corrigendum NO.1, British Standards.
  9. EN ISO 14644-4:2001, Clean-rooms and associated controlled environments: design, construction and start-up, Incorporating Corrigendum NO.1, British Standards.
  10. EN ISO 14644-6:2001, Clean-rooms and associated controlled environments: vocabulary, British Standards.
  11. ISO 14644-2:2000, Clean-rooms and associated controlled environments: specifications for testing and monitoring to prove continued compliance with ISO 14644-1.
  12. ISO/TR 14969: 2005, Technical report on medical devices: quality management systems, Brussels, European Commission of Standardization.
  13. Q & A n.d., Radiation sterilization validation, Pacific Biolabs Inc.

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