Cleanrooms are highly specialised infrastructure conventionally used for manufacturing in Pharmaceutical, Biotech, Healthcare, Semiconductors, Nanotechnology and other industries to control the airborne particles that can be hazardous to the end product and the operator working in the environment.
Cleanrooms demand regular cleaning and disinfection, including the cleanroom equipment. The cleaning agents and disinfectants used must comply with the GMP guidelines and recommendations that offer optimum safety.
Hygiene training is essential, as every employee associated with the Cleanroom is accountable for maintaining hygienic production conditions. The hygiene standards followed in cleanrooms are demanding. Yet, the COVID-19 pandemic crisis calls for an evaluation of the current practices and incorporation of precautionary measures to safeguard employees, manufacturing facilities and offices against this health threat.
HVAC systems help to maintain the cleanroom facility in a sanitised condition to ensure cleanliness and maintain production efficiency. However, when ideal conditions meet human behaviour, especially in such controlled environments, there are regulations and rules to be followed to ensure an environment free from bacteria, pathogens and airborne particles under a specified limit.
ISO classification system classifies Cleanrooms depending upon the size and quantity of particles per volume of air. The pre-requisites applicable for any cleanroom is
- keeping contaminants at bay
- Equipment should not generate contaminants
- Addressing accumulation and elimination of pollutants immediately
The sources of contamination include the plant or facility itself, the operators or personnel working, machinery and tools, fluids and the raw materials used to manufacture the drug. These are essential factors to be considered while working in a Cleanroom.
We suggest a few easy-to-follow recommendations to keep the laboratory air quality clean and increase its productivity.
- Cleanroom area should be of an optimal size. Large spaces can be divided into numerous zones depending on the requirement.
- Pathways should always be free from any obstructions.
- Critical workstations should be distant from the entrance and exit for minimal contamination.
- Air Showers, Mist Showers and De dusting tunnels should be installed for entry and exit of personnel and materials respectively.
- A couple of things to be followed is to keep the work stations neat and tidy for the next person to use. This includes the removal of personal things from general-use areas. Materials intended for a take away from the workplace should be bagged in zip-lock bags to avoid contamination.
2. Laboratory and Production Facility
- The lab or production facility should store a minimal amount of materials. Space should be clean and tidy and free from airborne particle accumulation.
- Table-tops must be kept clutter-free
- It is crucial to conduct a priority check of work desk daily before leaving to ensure proper placement of items.
- Personal items must be labelled to include the concerned person’s credential that may include their name, contact number and organisation id. The storage in the lab is limited to a storage bin; however, additional storage space can be available outside the Cleanrooms.
- Any material or chemical should not be left unattended, and it is imperative to label them to avoid contamination or health hazards. The label should include details like material or solution if it contains any potent substances, name of personnel and date. Any substances left on the counters or without the details should be discarded unless specified on the label.
- When leaving the Cleanroom, the last personnel needs to ensure to switch off the utilities and gas supplies and the first person to enter the Cleanroom in the morning needs to ensure the utilities need to be turned on.
3. Gowning and Hygiene Factor
- One of the primary sources of microbial contamination are the working personnel. Hence a crucial aspect of preserving clean air is to maintain correct gowning techniques. It is essential for employees moving too and fro to different areas to undergo changing of garments to maintain cleanliness (depending on the level maintained in the Cleanroom). However, ninety-five per cent of contamination comes from workers hence limiting the personnel’s movement is absolutely essential.
- Gowning procedures as per cleanroom classification must always be worn in the Cleanroom.
- Once at work, it is essential for employees to perform a primary cleaning of the exposed body parts, i.e. the face, hands, and lower arms before changing. Cleaning using approved sanitising soap helps get rid of skin care products, dirt, and makeup, which could contaminate the Cleanroom. Jewellery such as rings, watches, necklaces, and so on needs to be removed.
- Before entering the gowning room, an employee must ensure good hygiene practice. The personnel need to follow a proper aseptic gowning procedure to ensure they are donning all cleanroom-compatible components to work in the lab for that includes wearing a sterile hood to cover hair and ears, garments, face mask, safety glasses, plastic gloves, shoes and gloves depending on the cleanroom classification This helps keep the sterile cleanroom environment free of impurities.
- A list of acceptable materials accessible to all the Cleanroom personnel will help to keep the cleanroom environment free from contaminants.
- The materials acceptable in the Cleanrooms are cleanroom-approved notebooks and papers, ball-point pens materials with smooth, hard surfaces which can be cleaned with alcohol wipes.
- The materials which are not acceptable in the cleanroom environment are food products, eatables including chewing gum, wood products regular paper, tissues, cardboard, books, and magazines, Styrofoam products, any powders, erasers, pencils, felt-tipped pens, aerosols etc.
Apart from the rigorous hygiene practices new norms like physical distancing and Installing Sensor activated dispensers for sanitiser should be incorporated in lieu of COVID-19, especially in the labs and the gowning areas to ensure safe and healthy practices for the cleanroom workforce.
This post was originally published on our Air blog.