Protocol Planning for Cleanroom Builds

Building a cleanroom isn’t just a construction project. It’s a precision operation that requires strict environmental control before the walls even go up. The moment trades enter a space that will become classified, contamination risk begins. If you don’t have standard operating procedures, trained crews, and a contamination control work plan in place before construction starts, your cleanroom is already behind schedule. 

Contamination Starts Before You Think It Does 

Controlled environments face risks long before final wipe-downs or certification testing. Dust, debris, tools, and even the clothing worn by untrained workers introduce particles that compromise downstream performance. Most projects miss this. Contractors install ductwork, run pipe, or build walls under the assumption that cleaning will come later. 

But if you’re planning to validate the space for cGMP production, any contamination that enters the controlled zone must be remediated. That often means much more than a mop and a wipe-down. 

What Contamination Really Costs 

Re-cleaning a space doesn’t just waste time. Every time a tradesperson walks in without proper gowning or uses unclean tools, they introduce contaminants that delay the next crew. Schedules slip, inspections get rescheduled, and costs multiply. 

Contamination in your HVAC system adds up quickly. A single HEPA panel can cost over $700 to replace. Fan-filter units go beyond $1,000. Premium motorized HEPA units used in Class 100 and Class 10,000 spaces can reach $2,000 each. That doesn’t include installation or retesting. If multiple units are affected, costs escalate fast. 

What Should Be in Place Before Anyone Enters the Room 

Hygenix supports cleanroom construction teams with early contamination prevention measures tailored to each facility’s classification, use case, and construction plan.  

• Standard Operating Procedures (SOPs): Entry and exit protocols, tool cleaning, gowning, and material handling 

• Trade Training: Gowning demos, tool wipe-down procedures, and contamination awareness for subcontractors 

• Work Planning: Sequencing of trades, zoning by classification, and scheduling of cleaning rounds 

• Cleaning Protocols: Defined frequencies based on construction activity, with accountability built into daily workflows 

These plans are not optional. They need to be part of the construction sequence and reinforced through daily routines and supervision. 

Cleanroom Construction Needs Cleanroom Discipline 

Hygenix works with construction managers, owners, and design teams to implement contamination control strategies as early as schematic planning. We don’t wait until turnover to enforce cleanroom standards. Our protocols reduce delays, protect your investment in equipment and materials, and keep your facility on track for inspection and startup. 

Don’t Let Construction Become a Contamination Risk 

If your cleanroom project doesn’t include a contamination control plan during preconstruction, you’re already at risk. The cost of getting it wrong isn’t just measured in schedule delays. It shows up in real dollars and lost production time. 

Contact Hygenix today to put contamination control in place before construction begins.