Establishing an Effective Environmental Monitoring Plan within a Cleanroom – Medical Devices

The risks contributed by environmental hazards involve a broad spectrum of health complications firmly linked with the sources of contamination like air, water and equipment. Achieving a clean room environment free of contaminants relies on monitoring of microorganisms that may accumulate over the equipment or devices used in hospital units. Particulate monitoring of samples gives detailed information of microbial growth. There is certain literature scarcity in the area of environmental monitoring plan in achieving and establishing a clean room keeping in view of medical device usage. Therefore the main objective of the study is to highlight environment monitoring strategies for clean room atmosphere where medical devices are used regularly and provide a proposal. A literature search was conducted using databases like pubmed. Articles other than English were excluded. A total of 17 sites in ICU’’s of multispecialty hospital will be selected. Informed consent will be obtained from the staff who will be interviewed through questionnaires to seek information on medical device usage like catheters, endocscopy, ventilators, safety guidelines, standardization methods followed etc.For air monitoring microbiologically, Rodac plates of blood agar and trypticase soy agar, will be used for growing the microbes. Sampling sites may include clean rooms, cabinets and incubators etc. The study will be carried out for a period of one year and six months. An incubation period of 32oC for seven days will be followed for the culture media. Quality control will be assessed through positive and negative controls. Results will be interpreted wit the help of statistical software STAR.In conclusion; literature search on monitoring of environment has yielded significant information to devise a standardized plan for achieving better clean room environment where medical devices are common.

Hazards contributed by environmental contamination pose a major threat to the society from several corners. Important agents considered to carry risk are air and water. These sources facilitate the rapid spread of infectious microorganisms by becoming favorable when needed. With this, the breeding and multiplication of microorganisms gets intensified and results in severe health consequences.

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Especially, the risk would be even more with devices handled in hospitals as they contribute to infections when contaminated. There is a need to monitor the environment with appropriate infrastructure set up. To say, Environmental monitoring constitutes the examination of hazardous factors like pollutants, chemical agents, bacteria and toxins in a particular region. The regions may be mostly specific environmental parts or work sites (Bennet 2012).The rationale for Environmental monitoring is for baseline evaluation, comparisons, overtime variation observation, exploring novel trends in environment, determining the project success and finally detecting the objectives that have been addressed (Bennet 2012). Whenever an unnecessary outcome occurs, early warnings need to be provided by the system of monitoring at the earliest which may be instant or of low level in complexity. Sampling methods employed and the site of collection or bio burden may play important role in the environmental monitoring to ensure a clean up of desired location. Similarly, failure to understand the data furnished by the research experiments, carried out for environmental clean up in an evidence based format would lead to improper assessment of framework being set by the experts in this strategy of environmental monitoring. There are certain defects in the organization system for environmental cleanup is yielding the beneficial output by environmental monitoring to discriminate the regions where the approach was applied and where not applied (Bennet 2012).

Examining of particulates that may serve as pollutants should be properly done for the appropriate study output. There is still some literature paucity in information with regard to the effective monitoring of environment that could form a basis and holds good for establishing a clean room atmosphere (Rönnbäck et al.2003).Therefore the main objective of the study is to highlight environment monitoring measures for clean room atmosphere where medical devices are handled routinely and provide a proposal.Initially, to ensure a clean monitoring of environment, sampling strategies were reported to be essential. Actually, in heath care, surface environmental sampling was not recommended by the Association for the Advancement of Medical Instrumentation (AAMI), the Centers for Disease Control and Prevention (CDC), and many organizations of health care. But, the Association for Professionals in Infection Control and Epidemiology (APIC) and CDC have agreed with such practice of environmental sampling under some special instances during the investigation of outbreak (Muscarell 2002).The reason for this practice implementation is related to gram-negative bacteria during hemodialysis, waterborne bacteremia, infections of patients and responses of pyrogens. For example, during the reprocessing of endoscope, the Food and Drug Administration’s (FDA) medical device reporting database and other relevant reviews on endoscope reprocessing have revealed that gram-negative bacteria could contaminate endoscopes that could lead to nosocomial outbreaks (Muscarell 2002). Hence, in order to reduce the infection risk to patients with gram-negative bacteria after endoscopy a sampling strategy was focused on rinse water used while reprocessing the endoscope (Muscarell 2002). Similarly, catheters used in hospitals or intensive care units (ICU) do carry infection. This is because these biomedical devices contribute to the formation of bacterial niche in the surrounding tissues.

Culturing of bacteria from various catheter sites and tissues nearby indicated that dominance of Enterococcus faecalis and ecoagulase-negative staphylococci (mostly taphylococcus epidermidis) (Broekhuizen et al. 2008). Operating rooms contribute to air contamination of microbes and pose a risk for infections during surgery. So air quality was determined in a study by counting particles and sampling microbes in operating theatres. Here, high-efficiency particulate air filters and conventional ventilation surgical theatres were considered for particle counting and air microbiological sampling in surgical theatres consisting of empty operating rooms.Microbiological counting and particle counting yielded different findings.

The former’s count was 38CFU/m3, and the latter’s was 46 262/m3, respectively.

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This has indicated that in traditionally ventilated operating theatres, microbiological sampling is more reliable than particle counting with regard to microbiological contamination measurement. Hence, microbiological counting could five more estimate of microbiological contamination (Landrin, Bissery & Kac 2005). For clean rooms, environmental monitoring programs have been devised hypothetically with regard t their utility in the RIVM (National Institute of Public Health and the Environment).Measurement approaches have been focused on colony forming units (cfu’s) that deposit on surfaces, glove fingertips, and even those of airborne. Areas where crucial handling was important like class A area is mostly given continuous priority during sampling work. Such areas are considered as required atmosphere to form areas known as supporting areas. Any variation in such areas which alters or disturbs the class A area quality was subjected to detection in sampling process which is continuous. So, supporting area sampling may indicate the stability of measured parameters. Here, sampling frequency which is per week, month or three times in a month would be considered from the sampling data procured earlier. This makes to rely on area use and their attachment with the operator’s behavior but not on parameter’s values mentioned previously on which the area classification and the lay out are dependant specifically (Hertroys et al. 1997).Therefore, following a schedule in sampling is essential as it furnishes insights on the areas of production and the related information with minimum trial. But the component that could lose during the porgramme evaluation forms the connection between the product contamination and monitoring of environment. This could shed light on the caution to be exercised and factors that need to be considered in the sampling areas (Hertroys et al. 1997).

For environmental monitoring and clean up strategies that concentrate on medical devices, it is also essential to consider the data on chemicals or pollutants of other sources. To this end, it was reported that exposure to environment may cause diseases in humans in small sections. The agents that contribute to such adverse reactions are chemicals being let out by sources which are on broad spectrum man made or of natural. In a region of South Texas birth defect known as anencephaly occurred at an increased rate. This made the researchers to sample the environmental media like sediment and surface water of agricultural canals and of Rio Grande River including pastures and cropland. A special strategy mostly important for this kind of investigation was use of United States Geological Survey (USGS) quadrangle maps (7.5′; 1:24,000 scale) (Garcia et al. 2001).This is to recognize the interesting areas suitable for sample collection. In each quadrangle, minimum of one sampling location was confirmed. Surface water sample collection was focused on pond and soil sample was obtained with a trowel made of stainless steel.Glass jar was used for collecting samples of sediment.

Soxhlet extractor that employed methylene chloride was used for collecting solid samples (Garcia et al. 2001).Water samples have given the source for organic chemicals that were deposited. These include estrogens released from industry, pesticides, plasticizers etc.The chemicals identified in environmental samples are benzene dicarboxylic acid and atrazine.It indicates that in samples obtained from environment xenobiotic estrogens and pesticides are mostly involved (Garcia et al. 2001). So, environmental monitoring intended for clean room atmosphere should consider the sources of industrial contamination as the manufacture of medical devices is carried out in industries on are scale with the use of specific chemical ingredients which when accumulated in larger amounts may favor the growth of infectious microbes by some unknown reactions.Next, the rooms in which the airborne particle concentrations are regulated in agreement with the particular cleanliness class of airborne particulate constitutes a Clean room.In order to conform to the present environment current Good Manufacturing Practices (CGMP), the medical device manufacturing environment should be monitored. Many factors are reported be important like the individuals who are competent should define the manufacture critical areas, perform compilation and analysis of laboratory results, and support a system to pool all the generated results. Most importantly, establishment of limits for significant increases or variations in the environment’s colony forming unit numbers should be done (Environmental Monitoring n.d.).These limits are nothing but Action and Alert Limits. The action levels constitute microbiological levels when become abnormal in their limits in the controlled environment stimulate a probe and precise intervention based on the research study. Whereas, alert levels constitute the microbiological levels in the standard operating procedure mentioned particularly, which when become abnormal should lead to a probe to guarantee that the process is not out of control. Once the adequate data is gathered, establishment of Action and Alert Limits would be done for annually (Environmental Monitoring n.d.). With this, it would be feasible to determine the growth range and numbering that would draw the reviewer’s attention that reflects manufacturing process drift or trends that underlie. Here, procedures written in an outline format for alert or action levels should be accessible. Actions in corrected format may involve a process of cleaning for vital areas for recovered organism(s) characterization and manufacturing line. Organism characterization may involve identification of organism, colony morphology, gram morphology etc. So, the action and alert limits need to be re estimated to guarantee the relevance of the levels. Close observation of these limits is mandatory when there is terminal sterilization in the manufacturing process (Environmental Monitoring n.d.).Further, particulate monitoring is very important in the environmental monitoring of clean room. Since long time, Whatman was considered as important for filtration product supply in the application of environmental monitoring.

Globally, this product has received widespread demand to guarantee results precisely.

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Whatman filter papers are mostly used to monitor the emissions of water and air.Its product PM 2.5 PTFE filters is widely used by US EPA (United States Environment Protection Agency) for wide range of programs on particulate monitoring (Environmental Monitoring 2009). As such, in healthcare settings avoiding contamination is important to the medical devoices and also to the staff and patient safety. Even gases and liquids need a stable cleaning to facilitate the healthcare methodologies and procedure integrity (Medical Devices 2009). Globally, whatman products are considered best in serving OEM devices. Their application segments include high pressure line filters, respiratory therapy, suction and vacuum protection, hospital wash water and several equipments of sterilization (Medical Devices 2009).Clean room audits are essential in the process of developing a clean room with regard to the guidelines of Good Manufacturing practice (GMP).Here, awareness on every single aspect of room and its accessibility is essential. It encompasses room delivery of supplies and equipment, people’s knowledge of sterilization techniques, regulating room access and security. Room ventilation and worker protection keeping in view of exposure to hazardous equipments and substances, are in addition to be maintained (Beach Justin n.d.). So, GMP clean room guidelines are to be adhered in the country of manufacture or clean room design as per every national government and World Health Organization (WHO) (Beach Justin n.d.).During environmental monitoring, there is need to consider the bioburden sampling. A Bioburden constitutes evaluation of medical device or product before sterilization or viable microorganisms quantitatively. It is vital in sterilization test evaluation that assesses sterilization in tracking the amounts of bioburden (Bioburden 2010). Any fluctuation in counts of burden indicates an alteration of the handling or manufacture of the specific product. So from the product to be tested methods of extracting microbes like sampling of surface, immersion, dilution and counting the number of viable microorganisms like Direct Plating and Most Probable Number (MPN) are considered (Bioburden 2010). Similarly, to ensure better environmental monitoring, endotoxin evaluation by sampling of airborne dust or water is done with aqueous extract analysis by a method of Limulus amoebocyte lysate (LAL) test (Mark et al. 1999).

Methodology: A multispecialty hospital will be selected with a special emphasis on intensive care units (ICU). Here, nearly 17 sites would be selected to serve as sample locations. The staff employed in the units will be approached and informed about the study. Informed consent will be obtained from the staff who will be interviewed through questionnaires and information will be collected on medical device usage like catheters, endocscopy,and ventilators and safety guidelines, standardization methods followed etc. Staff members may be nurses, doctors and technicians who will be routinely handling the medical devices like endocscopy, ventilators and catheters. A written consent will be obtained from the staff and a permission grant will be sought from the hospital authorities and ethical committee.

Questionnaire will be prepared that would seek information on the frequency of sterilization of the devices in use, old or newly purchased, standardization methods, protocols followed, previous history of any contamination in the unit, infections to the staff and patients etc. Sampling will be focused primarily on air.

The contamination sources may be the staff members, room structure, ventilation and finally medical devices. Microbial air contamination will be measured by enumeration of colony forming units per cubic meter [CFU m−3] of air by the atrium air sampler which utilizes 100 mm Petri dishes (Pasquarella, Pitzurra & Savino 2000). Passive air sampling will also be performed by settle plates. For this purpose, trypticase soy agar plates will be kept on and for four hours air exposed. For every localization case, plates for negative control, positive control, and plate problem will be used. This makes the microbes transferred from inert particles to settle on agar surface at the rate of 0·46 cm s−1 (Whyte 1995).

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For microbial monitoring of surfaces, a RODAC (Replicate organism detection and counting) plate will be used and pressed against the surface used for sampling. All this process will be done in the trypticase soy agar plate present in a Petri dish(Cobo & Concha 2007).The sampling locations include surfaces like floors of clean rooms, under the centrifuges and CO2 incubators, tables supporting microscopes and inner regions of biological safety cabinets(Cobo & Concha 2007). Plates will be incubated to enable the transport of microbes to the agar from the surface and colony formation. The total duration of the study will be approximately 1 year 6 months. The sampling frequency will be carried once in a week. Another environmental control will be carried out following clean room variation with several types of cell cultures and that of particulate with larger potential of air filter change. The media used for culture will be in agreement with the United States Pharmacopeia.

The agar plates will be of 90mm size and 32°C incubation for 7 days will be used for monitoring active air and settle plates. Whereas, same incubation condition will be used for agar plate of 55 mm in the Rodac plate, for testing the contact plate with trypticase soy agar. All the plates will be daily checked to observe the microorganism growth (Cobo & Concha 2007).

For quality control test, both negative and positive controls of internal quality assurance will be used to detect the viability of the culture process. All microbes isolated will be basically identified by gram staining during the routine environmental monitoring with their staining potential and morphology of cell (Cobo & Concha 2007). As water may become the source of endotoxin for finished medical devices, endotoxin levels will be checked when water is a constituent of medical device or has contact with it, by LAL assay. Results will be interpreted statistically by software STARS (Statistical Trending and Reporting System) which is also reliable for trending and reporting data in the Pharmaceutical laboratory (STARS.Net 2005).

References

Beach Justin, n.d., What Is the Meaning of a GMP Clean Room?, 2012, Web.

Bennet Tiffany 2012, Environmental monitoring definition, Web.

Bioburden 2010, Web.

Broekhuizen CA, Schultz MJ, van der Wal AC, Boszhard L, de Boer L, Vandenbroucke-Grauls CM, & Zaat SA 2008, ‘Tissue around catheters is a niche for bacteria associated with medical device infection’, Crit Care Med, vol. 36 no.2,pp.395-402.

Cobo, F, & Concha, A 2007, ‘Environmental microbial contamination in a stem cell bank’, Letters in Applied Microbiology, vol. 44 no.4, pp. 379–386.

Environmental Monitoring of Manufacturing Processes n.d., 2012. Web.

Environmental Monitroing 2009, Web.

Garcia, SS, Ake, C, Clement, B, Huebner, HJ, Donnelly, KC, & Shalat, SL 2001, ‘Initial results of environmental monitoring in the Texas Rio Grande Valley’, Environ Int, 2001, vol.26 no.7-8, pp.465-74.

Hertroys, R, Van Vught, PA, & Van De Donk, HJ 1997, ‘Moving towards a (microbiological) environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: a hypothesis, a practical programme, and some results’, PDA J Pharm Sci Technol, vol.51 no.1, pp.52-9.

Landrin, A, Bissery, A, & Kac, G 2005,’Monitoring air sampling in operating theatres: can particle counting replace microbiological sampling?’, J Hosp Infect,vol.61 no.1, pp.27-9.

Mark D, Ert Van,Clifton, D,Crutchfield & Sullivan John B. 1999, “Clinical Environmental Health and Toxic Exposures”, In John Burke Sullivan & Gary R Krieger (ed.), Principles of environmental and occupational hazard assessment, Lippincot Williams &Wlliams, USA, pp.43.

Medical Devices 2009, Web.

Muscarella, LF 2003, ‘Application of environmental sampling to flexible endoscope reprocessing: the importance of monitoring the rinse water’, Infect Control Hosp Epidemiol, vol. 23 no.5, pp.285-9.

Pasquarella, C, Pitzurra, O, & Savino, A 2000, ‘The index of microbial air contamination’, J Hosp Infect, vol.46, pp. 241–256.

Rönnbäck, BI, Nordberg, ML, Olsson, A, & Ostman, A 2003, ‘Evaluation of environmental monitoring strategies’, Ambio, vol.32 no.8, pp. 495-501.

STARS.Net 2005, Web.

Whyte, W 1995, ‘Sterility assurance and models for assessing bacterial contamination’, J Parenter Sci Technol, vol. 40, 188–197.

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