Conventional vs inclusiv Cleanrooms

Conventional Cleanrooms can have poor airflow designs resulting in frequent and persistent contamination.

Inadequate Cleanroom designs can reduce the effective ACH of the Cleanroom by:

• Placing air returns in less-than-optimal cleanroom locations for air sweeping effects
• Placing HEPA filters directly above exhausted Biological Safety Cabinets

Cleanroom sterility depends on multiple inter-related factors that require consideration for an effective design:

• Room geometry and layout
• Placement of Primary Engineering Controls, accessories, automation, and door openings
• HEPA filter ceiling design
• Low air returns and airflows

Keeping such relevant factors in mind, inclusiv Cleanrooms leverage the cGMP and engineering design expertise of Grifols with a comprehensive approach to facility design, engineering controls, environmental monitoring, and equipment installation.

Conventional hydroscopic construction materials can promote microbial growth, or shed particulate that can be a hidden source of contamination. Many cleanroom designs utilize construction materials (e.g. drywall or MDF) promoting microbial growth via their hydroscopic nature.

Along with their hydroscopic characteristics, those materials are highly susceptible to contamination as they are prone to over time settlement and damage such as:

• Micro-cracks
• Inclusions
• Shedding particulate from unlaminated or damaged areas

inclusiv Cleanroom designs utilize pharma grade materials:

• Highly durable
• Non-hydroscopic
• Antimicrobial
• Resistant to UV and typical cleanroom cleaning solutions
• Do not release particulate even from areas that may become damaged over time

Conventional Cleanrooms with inadequate flooring materials and design can encourage contamination. Many Cleanrooms are designed with tile and grout or vinyl tile floors, which can become a source of contamination:

• Seams between tiles accumulate contamination with prolonged use
• Vinyl tiles can separate from the floor or excessively wear

inclusiv Cleanrooms are designed with non-hydroscopic, durable, easily cleanable materials.

Grifols uses two Cleanroom flooring types depending on durability needs:

• Hot welded sheet vinyl
• Poured epoxy for high traffic areas

Conventional Cleanrooms can encourage contamination accumulation with sharp internal angles and unsealed joints which accumulate contamination.

• Seams between tiles accumulate contamination with prolonged use
• Vinyl tiles can separate from the floor or excessively wear

A long history and developed expertise in designing cGMP manufacturing facilities provides Grifols the experience to identify and minimize these issues.

Joints in inclusiv Cleanrooms are:

• Flush and cold-welded for airtight enclosures: Protecting the classified space from microbial contamination and other spaces from hazardous drug contamination.
• Coved and sealed for contamination prevention: Protecting the classified space from microbial contamination and other spaces from hazardous drug contamination.

Conventional Cleanrooms use sealed ceiling tiles that leak over time. Gaining access to above the ceiling requires opening ceiling tiles and recertifying the Cleanroom. Challenged with frequent pressure changes, such as opening doors, many cleanroom designs specify non-walkable sealed grid and tile systems.

The frequent pressure fatigues these designs leading to:

• Sealant failure
• Popped tiles
• Compromised integrity of the cleanroom

Gaining access to the sealed systems above the ceiling is key in providing proper maintenance.

inclusiv Cleanrooms are designed with large air-tight and walkable ceiling panels, allowing access to space above the cleanroom for maintenance.

Conventional Cleanrooms can encourage contamination with floors and walls joints that are not flush Traditional construction often uses difficult-to-clean right angles that become collection points for unwanted materials.

Even coved joints are a frequent source of contamination with traditional materials, creating an often-neglected horizontal surface and internal angle with their capping or flashing at the wall.

inclusiv Cleanrooms are designed with seamless integral cove bases that meet flush to the wall with a sealed joint to minimize contamination and cleaning effort.