At LTS, we integrate current Good Manufacturing Practice (cGMP) and ISO standards into the earliest stages of cleanroom planning.

Our goal is to design facilities that are:

1. Technically sound
2. Operationally efficient
3. Easily inspectable
4. Built to scale

We take a systems approach — aligning process logic, risk management, and infrastructure planning so compliance is embedded, not added later.

While air handling and pressurisation are critical, compliance is not driven by HVAC alone. It’s driven by how the facility functions as a whole.

That’s why we plan cleanrooms across three integrated dimensions:

1. Process flow – How raw materials, samples, and people move through the space
2. Contamination control – Preventing cross-contamination at every step
3. Infrastructure logic – Designing for monitoring, access, validation, and future change

This means our cleanroom design doesn’t just follow guidelines — it supports real-world operations.

To bring this to life, our team evaluates and integrates the following core elements:

1. Cleanroom classification – Matching ISO classes to function
2. Room zoning – Layered by pressure, activity, and contamination risk
3. Personnel flow – With gowning sequences, airlocks, and material segregation
4. Air handling systems – Including HEPA filtration, air change rates, and pressurisation
5. Temperature and humidity control – Based on process and occupancy loads
6. Surface finishes – Non-porous, smooth, and cleanable to standard
7. Process equipment integration – Aligned with workflow and maintenance logic
8. Cleaning protocols – Designed for frequency, access, and residue management
9. Monitoring systems – Including viable and non-viable particle tracking
10. Emergency and contingency planning – For utility failure and contamination events
11. Documentation and validation readiness – So nothing gets left to guesswork

Each factor is not just a spec — it’s a decision. And when one changes, the others must respond.

A well-designed cleanroom does more than pass inspection.

It scales. It adapts. It operates without drama.

At LTS, we embed adaptability into the blueprint.
That means planning for:

1. Volume growth
   Platform shifts (e.g. PCR to NGS)
2. Regulatory tightening
3. Operational handover to future teams

And when needed, we stay involved — supporting commissioning, SOP alignment, and team onboarding.

Because in regulated environments, the cost of retrofitting compliance is always higher than designing for it from the start.