How does a service provider earn the trust of a pharma client? How does their relationship evolve over time? Can an FM company confidently take on the responsibility of servicing even the core areas of a pharma manufacturing facility? Vinod Nair, Head – Business Transformation, ISS Facility Services India Pvt Ltd, has all the answers.
What are the unique challenges of cleaning in the pharma industry?
Unlike other manufacturing facilities, pharma is a highly regulated environment with statutory laws and clearly defined cleaning standards. Governing bodies such as the Food & Drug Administration (FDA) conduct regular audits, including of the cleaning program. When cleaning in such an environment is outsourced, the stakes are high.
Anyone deployed for housekeeping at a pharma manufacturing facility needs to be made aware and understand that he or she needs to work within the ambit of rigid guidelines.
Can you elaborate on some of these challenges?
Personal hygiene of personnel is the cornerstone of pharma housekeeping. The focus on handwashing that has been universally embraced by the common man in the past two years, has always been there in the pharma sector.
The antiquated practice of issuing two pairs of uniforms to each employee who works six days a week, doesn’t work in pharma. The benchmarks for hygiene in pharma are much, much higher than in conventional cleaning; those who work here need to understand the difference between cleaning and sanitisation, and be able to address both needs.
The product that is being manufactured on the production line has a direct bearing on the cleaning procedure. Last but not the least, every pharma company needs end-to-end documentation of the cleaning regimen.
Are pharma companies willing to outsource the cleaning of all areas?
Most service providers are restricted to cleaning the periphery of the production area; that area is usually cleaned by the pharma company itself. Some believe that by directly controlling just the core area, they have absolute control over the manufacturing environment. This is a myth. Lighting, air, pressure or any other utility – whatever goes into the production area is ‘manufactured’ outside it. So, the cleaning process needs to be standardised from end-to-end, whether done in-house or outsourced.
How does your manpower deployment strategy improve service delivery?
Most pharma manufacturing facilities are on the outskirts of cities, where local manpower is abundantly available. But in a sector which requires intensive training, can we afford to deploy a completely new team?
Usually, we assign a combination of 50-60% experienced, trained personnel along with a fresh cohort. This helps us set the ball rolling, and works well.
We also have a 45-90 day transition process to help housekeeping employees understand the cleaning regimen they have to implement, and that this regimen is the law. If someone is not suited for the task, they are withdrawn at this stage. By the end of the transition phase, we have a fully competent team at the site.
What advanced technology do you deploy at pharma sites?
The client always wants to be sure if there is 100% sanitisation. We have incorporated ATP testing to determine the efficacy of our cleaning procedures.
Robotic cleaning is the next big thing on the horizon, but it needs to be deployed in tandem with the existing infrastructure, and dovetailed with a time-motion study. Then we can go back to clients with suggestions for solutions that will bring in efficiency by saving both cost and time, which can range between 8-10%.
To what extent are services being outsourced today?
Based on the speed at which pharma clients outsource various services to us, we categorise it as first generation, second generation or third generation outsourcing.
In first generation outsourcing, the client is comfortable with handing over cleaning of peripheral areas, some pest control, dining services, security, transportation, parking management, waste management…services that are considered low-risk. When the client matures and the service provider also understands the client’s demands, second generation outsourcing begins, because the element of trust has been built. Clients then involve us in infrastructure management, meeting sustainability goals, providing laboratory boys who work in controlled environments etc.
Clean air, air conditioning, temperature and humidity control, which are all critical to the manufacturing process, can be and are being outsourced.
What further services can be outsourced?
Custom-made process equipment, which is made to order by a pharma company depending upon the production process, is not yet assigned to us for maintenance. We may not have the expertise yet, but with training, routine maintenance can be done.
On one side of the yellow line is utility equipment maintenance and core cleaning. Second and third generation outsourcing clients invite us to cross that line and enter the whole manufacturing facility. For example, I have a client who has asked me to calibrate their machinery; this is core manufacturing. The future is bright.