Introduction
There is a need to guarantee safety to the users of medical products. To achieve this the manufacturing processes must be free from any viable microorganisms be it bacterias, fungi or other moulds. These problems have been reduced through the establishment of a Central Decontamination Unit (CDUs) which provides sterilisation services. However, there is a need to constantly and periodically monitor any microbial contamination in the CDUs for early detection so as to take appropriate steps. The CDU provides sterilisation or decontamination services for purposes of producing medical devices that are reusable and safe for the patients usage and for the staff (NHS Orkney, 2008, para. 1). According to Byron (2008, para. 2), the main purpose of environmental monitoring includes the following; they provide information that is crucial for assessing the processing environment quality during manufacturing process, they detect and take measures against any adverse trends hence preventing any future microbial contamination, they prevent batches of products that may be contaminated from being released until appropriate standards are fulfilled, and many others. This essay provides notes on policies, procedures and schedules that are appropriate for environmental monitoring of microbial contamination in a CDU.
Available policies
Various organisations have come up to give policy guidelines to be followed during environmental monitoring for microbial contamination. The existing policies touches on the the bacterias or other contaminants in the atmosphere, the procedures to be followed and handing of the products (Jiminez, n.d, para. 4). They give the allowable limits of microbial contamination on the medical devices, policy on the state of the portable water to be used for pharmaceutical purposes, policies on sterility tests and the procedures for monitoring, policy guidelines on performance standards and control for the biological indicators of contamination, guidelines for rapid pharmaceutical analysis in case contamination is noted, among others. According to 3M (2002, para. 1), these policies provides consistency in the monitoring procedure in the different CDUs hence making implementation and audit very easy.
Procedures and schedules followed
Environmental monitoring is intended to control the viable microorganisms which contaminate medical products and also non viable particles in areas that are critical in the manufacturing processes. Monitoring of viable organisms involves tests to detect yeasts, bacterias, and molds and it consists of assessment of the personnel, the air and the surfaces in the CDUs.
Various CDUs carry monitoring on a regular basis like daily, weekly or quarterly so as to make sure their set policies and standards have been met. For air sampling two methods are available that are often used (Environmental Monitoring association, 2010, para. 5). The first method involves use of air samplers that draws a quantity of air that is usually determined beforehand. The air is then passed over a sterile Petri dish which is then incubated. After incubation the number of viable microorganisms per cubic meter or liter is calculated. This gives an indication on the level of contamination in the CDU (Scottish Executive Health Department, 2001, para.4). In the second technique that involves air sampling, Petri dishes are normally exposed to a CDU’s environment. In this case, sterile growth media will have been poured onto such Petri dishes.
The Petri dishes then stays for a specified period of time like 30 to 60 minutes and viable microorganisms that settle on the surface are incubated. Finally, a bacterial count is performed to determine the degreeof bacterial contamination.
For the surfaces in the CDUs two methods are also applied in sample collections. The first involves use of contact plates which contains sterile growth medium. To collect a sample the contact plate is pressed against the surfaces to be sampled and any viable organisms are collected and incubated (Williams, 2004, p. 20). A count is then made to establish the number of viable organisms. The second technique is the one that utilizes of swabs that is stored in a liquid which is sterilized. Here it uses the mechanism of subculturing in a media growth to determine the nature of microorganism. However, it’s important to note that use of swabs is more of qualitative than quantitative.
Finally, a complete environmental monitoring also involves assessment of the employees in the CDUs (Expert Witness, 2010, para. 5). The assessment involves use of contact plates like surfaces are monitored. The areas likely to come into contact with sterile fields or the products like hands that are gloved, the fore arms and others. Sample collection using the contact plates involves pressing them against their surfaces. Once the sample has been collected, it is then incubated at preset conditions after which the bacterial count is done.
Conclusion
In conclusion, the CDU provides sterilisation or decontamination services for purposes of producing medical devices that are reusable and safe for the patients usage and for the staff. According to Moldenhauer(2005, p. 20), environmental monitoring includes the following; they provide information that is crucial for assessing the processing environment quality during manufacturing process, they detect and take measures against any adverse trends hence preventing any future microbial contamination, they prevent batches of products that may be contaminated from being released until appropriate standards are fulfilled, and many others. There are various policies set out to guide the process of environmental monitoring. Monitoring of viable organisms involves tests to detect yeasts, bacterias, and molds and it consists of assessment of the personnel, the air and the surfaces in the CDUs. The monitoring should be efficient so that CDUs can produce quality products that are health friendly.
Reference list
Byron, Angel (2008). Implementation of Microbial Environmental Monitoring Program for Non-Aseptic Pharmaceutical Processes. American Pharmaceutical Review. Web.
Environmental Monitoring Association (2010). Environmental Monitoring Helps You Keep a Facility Under Control. Modern Plastics Worldwide. Web.
Expert Witness (2010). Expert in Microbial Contamination Issues. Web.
Jimenez, Luis (n.d). Microbial Contamination Control in The Pharmaceutical Industry. 2010. Web.
Moldenhauer, Jeanne (2005). Environmental Monitoring: A Comprehensive Handbook, Volume 2. PDA Books.
NHS Orkney (2008). Central Decontamination Unit. Web.
Scottish Executive Health Department (2001). The Decontamination of Surgical Instruments and Other Medical Devices. Web.
Williams, Kevin (2004). Microbial Contamination Control in Parenteral Manufacturing. Oregon, Informal Health Care.
3M (2002). Starting or Expanding Your Environmental Monitoring Program. Web.