Cleanroom apparel management: cost, compliance, and outsourcing

Outsourcing cleanroom apparel has many tangible and intangible benefits for pharmaceutical companies, says industry veteran Shyam Khante. 

The pharmaceutical industry’s future looks bright. The global market for medicines projected to rise to USD 1.9 trillion by 2027.

However, amidst optimism, several challenges threaten to increase expenses and further complicate manufacturing. Increasing R&D and manufacturing costs, rising demand for personalized medicine, and stricter regulations are prompting pharmaceutical companies to streamline operations and find savings. 

One way to tackle the challenges is to outsource non-essential parts of the production process. The shift has been long in the making, says Shyam Khante, President of Shyam Khante & Associates. Kante spoke at Lindström’s Global Pharma Tribe meeting in Helsinki in October. When he started his career in pharma four decades ago, the concept of outsourcing was outlandish. Stringent policies were implemented in-house to safeguard confidentiality.

“We were virtually told that research is a holy cow. So forget anything that could be outsourced. The guys in the research had a separate timeslot for lunch so that people didn’t talk to each other and couldn’t outsource their gossip, too,” Khante reminisces with a chuckle. 

“Now, everything is outsourced because there are many mundane things that are not part of the highly confidential process.” 

Shyam Khante, President of Shyam Khante & Associates.

The benefits of outsourcing cleanroom apparel management 

As pharmaceutical companies seek outsourcing options, eyes turn to the cleanroom and the garments personnel wear in the critical areas. In the wake of the new EU GMP Annex I and its stringent demands for garment management and quality assurance, in-house cleanroom garment management is becoming increasingly challenging. The initial investments for garment management are high. The daily process furthermore requires a lot of resources, training, and expertise. Ultimately, the failure to comply with industry standards and legislation can lead to catastrophic results. 

To address these challenges, an increasing number of pharmaceutical companies opt to outsource their cleanroom garment process to specialized service providers. There are many benefits to this, Khante explains. Outsourcing cleanroom apparel management can offer cost savings and complement the company’s expertise. At the same time, assuring compliance, while the organization can focus on its core business; manufacturing pharmaceuticals. 

“One of the most important benefits in outsourcing is the intangible cost and the regulatory hassle of keeping the operation inside the organization,” he says. 

Outsourcing can guard the manufacturer against many risks related to cleanroom garment management. Risks include cross-contamination, chemical exposure, or inconsistent cleaning quality. Partnering up can also unlock the benefits of utilizing digital technology in streamlining operations and enabling better traceability and documentation.  

One of the key perks of outsourcing is the saved time and resources what would otherwise be spent in meeting validation obligations of the advanced regulatory agencies. 

“Just imagine the amount of expensive managerial time the industry spends on some of the more mundane documentation”, Khante says.

“Outsourcing is not a luxury; it’s essential. Let’s not waste our bandwidth and time in doing something where others are the experts.” 

Meeting high expectations 

The pharmaceutical industry is ever-evolving. Khante argues that resolving many problems still does not change the number of worries. When addressing one issue, another one emerges. Currently, environmental concerns, such as water contamination and eco-friendly garments, are high on pharma’s agenda. 

“There are many regulations already in practice in Europe I don’t think the time is far away that they will come to developing economies. The industry can be caught sleeping, and this is another area where we as partners can show our importance.” 

The pharmaceutical industry also has a laundry list of demands for their service providers. As the industry moves towards more specialized production, the requirements for suppliers and partners will become more complex and specific, Khante says. 

Some of the industry’s visions, such as smart garments or nanotechnology-enhanced self-sanitizing fabrics, may sound like science fiction. Khante however assures these are just around the corner. 

“This sounds very futuristic, but it’s what the industry is now thinking. We need to be ready for these industry expectations.”

Shyam Khante, President of Shyam Khante & Associates

Shyam Khante has more than 40 years of experience in pharmaceutical manufacturing and technology, management & quality systems. He is the President of Shyam Khante & Associates and his contributions to the Indian pharmaceutical industry has been recognized by the IDMA, IPA and EDQM.