Biotech companies in Cambridge and Kendall Square must ensure that their clean rooms always meet GMP standards. As with so many other things, doing so is often easier said than done. Companies are faced with a number of challenges that can make maintaining standards difficult. And yet, it must be done.
Below are some of the challenges that biotech companies face with their clean rooms. As you read, bear in mind that All Pro Cleaning Systems offers commercial-grade cleaning services for companies throughout the greater Boston area. We can keep your biotech clean room in Cambridge or Kendall Square clean and up to standards.
Challenge #1: Space
One of the biggest challenges in Cambridge and Kendall Square is space. Rental facilities often retrofit older labs or office spaces into high-density rental space, leaving biotech companies with relatively small footprints. Smaller spaces intensify risk in everything from personnel and material flows to product stream segregation and contamination control.
The problems can be exacerbated when organizations are forced to share flexible clean room space. The more organizations that use the same space, the higher the risks for all of them.
Challenge #2: Design and Airflow
GMP standards often call for integrated and complex HVAC systems and pressure cascades. This can complicate unidirectional flows and material separation from adjacent spaces. Furthermore, building designers are challenged to maintain high energy efficiency and future flexibility while still validating HEPA performance, proper air change rates, and pressure differentials.
Challenge #3: Facility Flexibility
Both Cambridge and Kendall Square are known for being at the cutting edge of biotech technology. Facilities throughout the area increasingly support multiple modalities in the same facility. These could include cell and gene therapies, viral vectors, and biologics.
The result is that clean rooms need to be able to pivot between modalities quickly and efficiently. Keeping downtime to a minimum is non-negotiable. Regardless, clean rooms must still meet strict IQ/OQ/PQ and change-control standards.
Challenge #4: Contamination Control
Once in full operation, facilities must maintain rigorous monitoring. They must also accommodate multiple tenants, mixed project teams, and even high turnover rates among staff. All of this affects contamination control. Despite so many moving parts, attention must still be paid to disinfection and EM programs so as to avoid unwanted scrutiny from the FDA.
Challenge #5: Scalability
Rounding out the list of challenges is scalability. Cambridge and Kendall Square biotech companies often need to scale from pre-GMP labs to full production on a compressed timeline. Moving quickly can have negative impacts on clean room qualification and documentation. All the while, a facility must remain inspection-ready for both the FDA and other regulators.
A Word About GMP Standards
GMP (Good Manufacturing Practices) standards are a set of guidelines designed to ensure that products are consistently produced and controlled according to a defined set of standards. The standards apply to most clean room environments. They cover various aspects of sanitation, facility maintenance, equipment maintenance, and even staff training.
Any commercial cleaning company handling a clean room on behalf of a biotech firm would need to be able to clean according to such standards. The cleaning provider wouldn’t be allowed to deviate from them. Doing so would jeopardize the biotech firm.
All Pro Cleaning Systems is intimately familiar with both GMP standards and clean room cleaning. We employ the latest tools, techniques, and cleaning solutions to ensure that clean rooms are both surface clean and disinfected. For more information about our cleaning services in Cambridge and Kendall Square, don’t hesitate to contact us. We serve clients throughout the greater Boston area.