The entire process of cleaning & hygiene practices begins with recognizing the areas susceptible to contamination and taking necessary steps to maintain them. The areas with high human intervention and exposure to outer environments are considered as high contamination areas. Manufacturing facilities are a high-risk source for contamination from metal, metal oxides, building materials, ceramics, dust, personnel, process air, air filtration systems and machines.
[box type=”shadow” ]Cleaning & hygiene practices vary with the nature of production in both the Pharma and Food Processing segments. Being prone to contamination at all stages of processing, these two sectors depend on high level of cleaning & hygiene practices to avoid contamination. Nikunj Sharma explores the best practices followed.[/box]
In food production units, process lines have the highest traffic and are contamination prone. If we further divide this area into kitchen, processing and packaging sections, the packing again is labor-intensive; whereas kitchens are material intensive, so chances of contamination are more in this area.
In drug manufacturing units, staff workers’ movement, quality of air, material used and equipment placed in the area can cause contamination. “In pharma, finished product areas are considered more prone to contamination and once contamination sets in, it cannot be reversed. Contamination taking place in various processing stage can be handled but in terminal stages the contamination of drug formulation is very critical,” avers Prashant Nagre, CEO, Fermenta Biotech Limited.
[box type=”shadow” ]“Normally, if a production plant runs for a week or so, then at least one complete day is
required to clean the equipment and ancillaries to avoid any cross contamination from previous batch. This occupancy roughly accounts for around 10-15% of the entire production time to the manufacturer..”
Contaminants & Cross Contamination
Common contaminants in both food and pharma processing industries are water and air borne particles/ infections. In pharma environments, microbial, chemical and human contamination, specifically are the major source of contamination. While specific contaminants in food sector include pests, fungus and rodents which carry the microbial load.
Cross contamination is one of the most critical issues in pharmaceutical manufacturing where the facility is dedicated for multiproduct. Whenever there is exchange of man or material between different product areas or equipment, there are more chances of cross contamination.
“Reasons for cross contamination can be manifold and caused by technical as well as organisational deficiencies. Insufficient cleaning of equipment, poor facility design or inappropriate design of the HVAC system may be reasons as well as contamination due via personnel or primary packing material. But also the design of the production process itself can be the cause for cross contamination. Human error, unidentified impurities, manufacturing failures and, most regrettably, deliberate uses of the incorrect ingredients are just some of the routine causes that contribute to the contamination in a manufacturing,” emphasises Dr K D Yadav, SVP – Technical, Kamani Oil Industries Pvt. Ltd.
Foreign particles or particulate matter is a common and big area of concern in pharma settings. The most hazardous microbial contaminants are Staphylococcus aureus, E.coli. The challenge is to clean the surfaces in a manner that the mops and other devices themselves do not leave contaminants & defeat the very purpose. Also, where relative humidity is important, wet mopping may not be an option, thus posing further challenge. This goal is met by having appropriate cooling and filtration system and pressure differential systems.
[box type=”shadow” ]“Human error, unidentified impurities, manufacturing failures and, most regrettably, deliberate uses of the incorrect ingredients are just some of the routine causes that contribute to the contamination in a manufacturing. ”[/box]
“Contamination and more specifically, cross contamination is the bane of pharma and food industries. HVAC systems ensure the comfort of personnel together with integrity of the products by controlling temperature, relative humidity, filtration and room pressures as required. Lighter particles get swept into the filters with the air currents, the heavier airborne contaminants tend to settle on floor. These together with contaminants from machinery, moving parts, lubricants and other equipment related consumables need to be physically cleaned from time to time.,” says B Gautham Baliga, Chair, ISHRAE Certification Program and member of ISHRAE Technical Committee & Indoor Environmental Quality.