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.
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“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.
Equipment and chemicals used for hygiene and cleaning
Food
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There are different tools for different purposes but no tool should leave behind any residue or impurity. Chemical cleansing involves a component of soap for cleaning and a component of disinfectant to reduce microbial load and it should not impart any kind of odour to the food. Other equipment comprises of vacuum cleaners both hand held as well as industrial vacuum cleaners.
Pharma
[box type=”shadow” ]“The new age food processing facilities are no longer inferior to pharmaceutical facilities. They actually use the same technologies – the same air lock system, level of hygiene and level of detailing that a pharma requires. ”[/box]
Basic surface cleansing of floors is done with detergent, IPA-based cleaners, benzalkonium chloride. Hand cleaning requires antiseptic and antibacterial liquid sanitizers to handle microbial environments and procedures. Rotation-based use of different cleansers is very important to avoid any microbial resistance building in the premises. Large ancillaries are also cleaned with caustic-based solutions and formulation depends on the type of microbial load and infection the area is prone too.
“Dedicated aircon systems for different zones together with pressure differential re
gime can prevent air borne cross contamination. Similar strategy is important with floor, surface & wall cleaning devices. Cleaning equipment used in one zone should not be used in another. If not practical, a rigorous and validated cleaning system should be in place for the cleaning equipment. An often neglected area of cleaning is AHU internals which can result in contamination. Dust and condensate water in AHU drain pans result in fungus formation. Proper fungicides may be required. Similarly, duct cleaning with appropriate devices at regular intervals will result a hygienic environment,” informs Baliga.
Risk Levels
In case of changeover in food industry, the probability of contamination is high but risk to health is very low. On contrary, in the pharma sector, the risk levels are quite high, as active ingredients pertaining to specific action may cause irreversible losses to the consumer.
Risk levels of cross contamination in multiproduct pharma manufacturing lines are quite high as therapeutic activity of two formulations may be entirely different and could be a case of serious health issues. For instance, a cancer drug and a CVD medicine. Whereas, in same class of drugs, the risk level is low, still cross contamination exists. For example, two different forms of antacids.
Investments on cleaning & maintenance
There are no set standards for investments on cleaning and maintenance and it differs from sector to sector and product to product. Basically, in a pharmaceutical setup the major investment is on the laboratory setup which is required to maintain the quality and purity of a drug formulation. For instance, cost of procuring a Class 10,000 and Class 100,000 cleanroom differs significantly in a pharma laboratory.
Speaking on the time spent for cleaning measures in a typical pharma unit, Nagre says, “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.”
In the food processing industry, the cost varies in proportion to the product’s shelf life. If the product is perishable, the higher the percentage of revenue will be invested to retain the freshness and quality. Hence, the nonperishable commodity would require less investment to retain its quality. Roughly around 2.5-3% of the total revenue is invested on maintaining housekeeping and hygiene in food & pharma manufacturing plants.
Comparing the current practice of housekeeping and hygiene in both the sectors, Ashwin Bhadri, CEO, Equinox Labs, informs, “The new age food processing facilities are no longer inferior to pharmaceutical facilities. They actually use the same technologies – the same air lock system, level of hygiene and level of detailing that a pharma requires. Food processing facilities have grown to the extent that many of them have consultants from the pharma background designing their facilities. Pharma products are consumed once in a month or lesser, whereas food products are consumed on a daily basis by people of all ages irrespective of whether they are sick or not. Hence, today the quality of food and the quality of pharma are equally important. Thus, infrastructure and processes-wise, food and pharma industries are now almost at the same level.”