After a comprehensive analysis of pharma FM, Edward Dsouza, President, ServiceMASTER India compiles a benchmark SOP for cleaning and hygiene in pharma facilities.
Mistake 1: Use of manual cleaning methods
These cannot be implemented, especially during full-scale production. Processes like manual scrubbing will become prohibitively cumbersome and time-consuming. Often, techniques and products used for cleaning during R&D are no longer feasible for full scale production, due to safety and/or environmental concerns.
Mistake 2: Implementing the wrong cleaning process
Selecting an inappropriate cleaning product/detergent for the cleaning task at hand all but ensures eventual inefficiency, longer cleaning times (meaning longer production-line down times), and greater difficulty in achieving cleaning validation.
Some service provider interventions
- Batch-to-batch change and product-to-product changes.
- Water-soluble and water-insoluble insights and procedures.
- Fluid Bed Dryer Bags must be specific to products, since they are difficult to clean.
- Predefined storage period for clean-in-place systems, to limit bacterial growth.
- HPLC technique and analytical method to determine the level of contamination.
- Expert analysis on Recovery Factor to ensure correct cleaning validation.
GMP guidelines for pharma
- Production hygiene: Pharma units are required to use suitable disinfectants (whether microbial, sterile or classic) in addition to sanitising the production unit manually. It is also essential to check the loading and unloading zones of the pharma product to prevent contamination. The walkways need to be cast in cement to help prevent the spread of impurities.
- Personnel hygiene: It is of utmost importance to promote personal hygiene among the staff that accesses factory floors. Guidelines stipulate the use of hygiene workwear (gloves, gowns, etc.) in the loading and unloading bays, storage areas, and other places. Additionally, if laundering of this workwear is needed, the task should be handled by approved contractors with standardised processes for pharma.
- Plant and surface disinfection: By using high-quality disinfectants deemed safe for use on surfaces. The facility should have walls, floors, and ceilings that can be regularly cleaned without damage, to ensure a contamination-free factory.
Types of disinfecting agents
Based on their spectrum of activity, efficacy, and action, and the needs of your factory, choose one:
- Non-oxidising disinfectants: These disinfectants are suitable against bacteria and work by cell wall destruction to deactivate germs. Some of these non-oxidising disinfectants may be more effective or cover a wider range of bacteria than their counterparts. E.g. alcohols, amphoteric, aldehydes, phenolic and quaternary ammonium compounds.
- Oxidising disinfectants: Oxidising disinfectants are best for use where staining is to be avoided, since they are colourless. In addition, these disinfectants work by destroying the cell wall of the microbe, causing leakage in the cytoplasm, thereby deactivating the microbe. E.g. hydrogen peroxide and peracetic acid.
Pharma manufacturing takes place within a series of specially controlled environments: cleanrooms. On one level, a cleanroom or clean zone is simply an area that is clean in terms of both particle counts (as defined in the international cleanroom standard ISO14644) and microbial counts (as defined in a second cleanroom standard for biocontamination control, ISO14698.
A cleanroom is defined as an environment in which several parameters like contamination, pressurisation, temperature & humidity and personnel access are controlled, monitored and maintained. The first three are characteristics of the HVAC system, which maintains the critical temperature of the production process, but may unwittingly become a source of contamination.
The HVAC threat
The HVAC system is the only source of air in the pharma production process. Air becomes a carrier and transmission route for airborne particles. The limitation of HEPA and MERV filters is an act of compromise. To keep IAQ in check, we suggest:
Installing UVGI coil at AHU: Between coil and blower, to disinfect the air flow at source. As per International Society for Pharmaceutical Engineering, the recommended ACH for a pharma production unit must be 9-20 ACH. Since this is a significant cost to energy consumption, the quality of air tends to get compromised. Ultraviolet Germicidal Irradiation system installation in AHU air stream is cost-effective and 99.99% efficient.
Installing UVGI coil in HVAC duct: When we have limitations of space in AHU design, this is the next solution we suggest. This disinfects bacteria/viruses in the moving air stream, keeping the duct clean and controlling the breeding of bacteria, moulds, viruses and yeast. This also improves duct life, and reduces duct vibration as well as duct cleaning needs.
Installing Upper Room UVGI in occupied areas: This is when the space does not have an HVAC system due to various reasons, and indoor air needs to be disinfected. Installation above 7.5 feet height treats airborne contaminants.
Smart Surface Disinfection Program
Using a scientific approach towards cleaning saves energy and time. This includes processes like Washroom Management Program, Floor Care Program, colour coding system etc. We also need to move away from traditional floor cleaning methods like two-bucket or three-bucket cleaning, which does not remove disinfectant residue from floors, to a mechanical way of cleaning, where the final stage in floor cleaning and disinfection is typically a rinse with sterile water using machines.
To safeguard personnel access to the production area or clean room area, antimicrobial treatment for surfaces and high touch point disinfection with 90 days efficacy is suggested.
Invisible contaminants penetrate more, and are more damaging than what the eye can see as dirty. So, a shift from cleanliness to hygiene is the right approach.