It’s safe to say the year 2020 has not been one to remember fondly. What started off as the beginning of an exciting new decade, seemingly overnight became the year of uncertainty, fear, and the question – where do we go from here?
Every industry around the world has been affected by the COVID-19 pandemic. Restaurants, salons, and retail stores have been forced to shut their doors. Many corporate employees have set-up offices in their homes. Children have been thrust headfirst into a digital world of teacher lessons and navigating schoolwork from their bedrooms. Nothing is the same – and people are asking themselves, will life return to normal after the pandemic?
With many aspects of life fundamentally affected, the honest answer is ‘no’. Just like any disaster, people learn, grow, and adapt from what they have experienced. Historically, the pharmaceutical and bio manufacturing industry have adapted and changed with new regulations, specifications and knowledge. Through every new discovery and technological advancement, the industry has evolved. This pandemic may alter the purchase of cleaning tools and training, industry manufacturing practices, and precautions taken moving forward. What can we expect?
The pharmaceutical industry has been moving towards integrating more automation into company processes over the past decade. The COVID-19 pandemic shows the benefit of less reliance on people in the production process.
“The greatest single source of contamination in a cleanroom environment is the people in it. Recent trends to automate processes and the use of disposable process components will continue, in part to reduce the contamination risk that people have on the manufacturing processes and cleanroom environments.” says Dave Nobile Contec’s Technical Services Manager. “The need to fundamentally clean and control microbial contamination in controlled environments will remain however, in whatever form those environments evolve.”
The push is not just to prevent potential contamination, or the risk of human error. The increase in use of robotics and automation offers more flexibility, greater speed and lowers operating costs.1 Speed to market can set companies apart very quickly.
The debate continues with various manufacturers and end-users regarding which is better – reusables or single-use products. This debate ranges from single use manufacturing equipment to mops and cleaning tools.
Human error and the risk of contamination have led more companies to pursue single-use products for the manufacturing of products and the contamination control steps taken between lots. This has taken a step further in recent years with single use tubing and pieces for manufacturing equipment thus preventing human error when it comes to cleaning properly and effectively.
“As with certain components of process equipment, disposable cleaning tools are also gaining in popularity,” says Chip Burnett, Technical Services Engineer. “We sell single use cleaning supplies because we know the risk of cross contamination is great with re-laundered products. Companies who use re-laundered products really need to ask themselves – Do I know where this came from? Do I know what other materials this was in contact with before I use it again in my facility? The answer is simple – no one knows.”
According to a survey of biopharmaceutical manufacturing professionals by BioPlan Associates, two of the leading reasons for adopting single use systems for manufacturing equipment were decreased risk of cross-product contamination and eliminating cleaning requirements.2
Increase Awareness of Dwell Time
The need for effective cleaning and disinfection is more apparent than ever. Disinfectants, IPA solutions and sanitizers are now in short supply as facilities increase their cleaning frequency. It’s important to remember for a disinfectant to be effective, the user must pay attention to the dwell time listed on the product label.
“We have seen time and time again, end users just spray and wipe with no consideration to wet contact time,” says Neil Simpson, Technical/R&D Manager of Product Development for Contec in Europe. “It is vitally important for end users to understand the contact time required for the product they are using and adhere to those times. Otherwise, the steps they are taking may not be disinfecting at all”.
Some products on the market require that a surface remain wet for 10 minutes or more. This is a very long time for a solution to remain wet on many surfaces, and often requires a product to be reapplied to meet the required dwell time. To be sure they meet these requirements, companies should look to validate products with a shorter contact time.
Application Method for Disinfectants
There are various techniques for applying disinfectants to surfaces. When it comes to mopping floors, the S-curve and place-and-pull methods are efficient. For walls and ceilings, horizontal, overlapping strokes, vertical overlapping strokes, or a combination of the two are the most widely used protocol options. Wipes should be used for all other surfaces, especially high-touch areas such as door knobs, light switches, keyboards, chairs and phones. Quarter-folding a wipe remains the most common practice for wiping surfaces such as tables and equipment.
With the increased need for knowledge regarding dwell time comes the reevaluation of the application method used to meet this time requirement. The first thing people think is to saturate the surface by applying a large amount of disinfectant through mopping or wiping. Although this makes sense in theory, the solution residue left behind, and potential equipment damage will be problematic in the future. For this reason, facilities may need to reevaluate the products used to apply disinfectants to surfaces. There may be something else available such as a presaturated wipe, flat mop or a different style bucket wringer that’s more ergonomic and provides a uniform layer on the surface.
Fogging is another way a facility can apply disinfectant to surfaces but there are some things to take into consideration. It’s important to remember, disinfectants must be applied to a clean surface. This means surfaces must be cleaned prior to fogging to ensure disinfectant efficacy. Keep in mind, fogging does not entail the mechanical action associated with cleaning a surface. This mechanical action of wiping or mopping a surface is instrumental to remove contaminants from surfaces. Additionally, it is critical to validate or demonstrate that the disinfectant is wet on all treated surfaces for the required dwell time in order to achieve desired efficacy.
Increase in Employee Training
As stated earlier, human error is the biggest source of contamination in a cleanroom. Whether it be things moving too quickly, or employee turnover leading to less experienced people, ongoing (or continuous) training is key to provide people with confidence and knowledge regarding the tasks they are performing routinely
Periodic reviews of procedures can be helpful to ensure correct protocols are in place to protect product and the people handling them. Various tools such as articles and videos are available to assist in things like cleaning best practices and how to use certain products. Mandatory review with these tools can ensure proper employee education before going to work in a critical cleanroom environment.
Identify a Second Source for Materials
In times of tight supply, facilities are finding it difficult to find the products they need to keep up with their production demand. Products such as IPA and nonwoven materials have been difficult to find. In the past, facilities have purchased these products from one supplier with no problem. However, allocations and limited manufacturing has made it difficult for some facilities to secure goods and materials to support ongoing production needs.
“The last few months, we have seen an uptick in interest for some of our products such as IPA and disinfectants,” says Renee Morley, Technical Services Specialist. “Moving forward, it will be important for facilities to build relationships with more than one vendor. Steps will need to be taken to obtain a second source for these materials.”
Many times, companies write vendor or product names into their standard operating procedures (SOP). This can cause problems when supply is limited, but an equal product may be available from another source. When it comes time to revalidate a disinfectant, or changes need to be made to an SOP, take into consideration listing a second product source, or specify materials in more generic terms in the SOP.
Where do we go from here?
Like any crisis, no one could foresee the side effects of the COVID-19 pandemic. From major family changes, to limited supply of product, to reevaluating processes to ensure the cleanliness of facilities, day-to-day patience and flexibility has been key to get through these trying times.
As we come through this, it’s important to take note what worked and what didn’t. Audit your procedures – what worked? What didn’t? What could you change? Is there a change you could make to better prepare you for the next crisis?
After all - “Those who cannot remember the past are condemned to repeat it.” – George Santayana
Note: This article is based on Contec’s perception of potential changes for the pharmaceutical industry in the months ahead based on conversations with customers and site-visits.