Table of Contents
This article covers cleanroom validation for an ISO 7 medical device cleanroom (Class 10,000). There are many different manufacturing standards associated with each different class of device and its end-use requirements.
ISO validation for a non-sterile medical device cleanroom does not mirror a cleanroom for sterile counterparts. It is the responsibility of the manufacturer to establish and validate the appropriate manufacturing processes, procedures, materials, and environments for a specific device.
In previous parts of this cleanroom build guide, we’ve covered each step of the cleanroom construction process including:
Medical Device Cleanroom Build Guide
Part 1: Walls, Windows, & Containment
Part 2: Electrical, Mechanical & Partitions
Part 3: Fan Filter Units – Ceiling Grids
Part 4: VCT Cleanroom Flooring
Part 5: HVAC Design & Fan Filter Integration
Part 6: Pressure Differentials, Humidity and Temperature Calibration
Part 7: Cleanroom ISO Class Validation
As-Built and At-Rest Cleanroom Differences
Above we see the primary production area of an ISO 7 medical device cleanroom (ISO 7 cleanroom area). The room is considered the equivalent of a class 10,000 (Class 10K) room by previous FED-STD-209 E cleanroom standards.
As-Built Cleanrooms
The cleanroom is now considered “As-Built”.
As-Built Cleanroom: Complete and ready for operation, with all services connected and functional, but without equipment or operating personnel.
At-Rest Cleanroom: Complete with all services functioning and with equipment installed and operating, as specified, but without operating personnel present.
Medical Device Cleanroom Validation
A well designed and diligently constructed cleanroom will meet every performance criteria for cleanroom validation after calibration. The PAC cleanroom pictured here required no adjustment and tested out at ISO 7 in all areas of the cleanroom.
What Happens the Cleanroom is Actually Cleaner than Required?
Most cleanroom designers over-spec fan filter requirements for a couple of reasons:
A) Fan filter blowers produce more noise and vibration at 100% capacity
B) Forward impeller fan filter designs run most efficiently at ~50% power
C) Filter media requires less frequent replacement at lower throughput rates
D) A single fan filter unit malfunction is less likely to compromise the room as a whole
E) Under-powered fan filter units become obsolete more quickly
Overcoming Efficiency Loss with Flexible Fan Filter Control Systems
HVAC is the most costly aspect of cleanroom operation: the HVAC system runs 24 hours a day, 7 days a week. Over-clocked cleanroom performance is best matched with a flexible fan filter control system. Here, the gowning room only requires an ISO 8 airflow and particulate sampling threshold.
So, how do we get best-case performance without sacrificing energy efficiency?
A cleanroom equipped with a smart fan filter system allows fan speed adjustment for any particular area, a specific fan filter, or room/group as needed. In this case, the fan filter units in the gowning room are easily dialed down to an air output appropriate for an ISO 8 cleanroom. Meanwhile, the facility may opt to maintain an ISO 7 environment during production hours, and reduce fan speed for energy savings during non-production hours.
Cleanroom Particulate Sampling & Validation
Particulate sampling verifies that each cleanroom zones falls within acceptable particulate count thresholds for ISO standards. The cleanroom is divided into zones called “bays”. A particle sample is taken within each bay to ensure that particulate removal is adequate and uniform across all spaces of the cleanroom. Air measurement devices measure and record adequate air velocity at each fan filter.
For more info on cleanroom particulate sampling and filter testing:
Particulate Sampling: Fan Filter & Particulate Sampling
Cleanroom Validation Specialists
A Validation Specialist oversees the final completion of a Facility Qualification protocol. The audit ensures that the cleanroom is built as specified and that final documentation reflects any modifications required throughout the build.
Cleanroom Audits
The audit first must verify and document facility paperwork and authenticate signatures. The final cleanroom configuration must accurately represent the architectural, mechanical, and electrical drawings including all revisions.
A comprehensive checklist documents that each item is found as specified, acceptable, and measurably verified.
Need clarification on a specific process? Leave us a comment, or request a call from one of our cleanroom specialists.
- Room surface finishes
- Electrical & lighting
- Plumbing
- Air handling unit inspection
- Filtration and HEPA filters
- Instrumentation
- Utilities
- Specifications and Purchase Orders
- Lubricants
- Spare Parts
- Engineering Documentation
- Standard Operating Procedures
- Instrument Calibrations
- HVAC System Start-Up and Test & Balance
- Room Air Change Rate
- HEPA Filter Integrity Test
- Room Particle Counts
- Room Pressure Differentials and Air Flows
- Room Temperature and Humidity Uniformity
- Room Particle Recovery Test
- Sound Level Testing
Cleanroom Validation Documents
The task-level process and validation procedure is facility-specific and varies between applied standards.
These documents may be helpful depending on your industry and application:
Title 21, Code of Federal Regulations, Part 820, current Quality System Regulations for Medical Devices, current edition.
Title 21, Code of Federal Regulations, Part 210 & 211, current Good Manufacturing Practices for Finished Pharmaceuticals, current edition
GHTF Study Group 3 – Quality Systems Process Validation Guidance Draft – February, 1999.
Guideline on General Principles of Process Validation, U.S. Food and Drug Administration, May, 1987.
ISPE Baseline Pharmaceutical Engineering Guidelines for New and Renovated Facilities Volume 5, Commissioning and Qualification. ISPE, 2001.
Simplifying Cleanroom Validation
Final ISO validation should be conducted by a third party organization. It’s a service every cleanroom provider should facilitate, and something included with every PAC cleanroom installation. PAC standards guarantee a cleanroom as-built that meets ISO standards as specified.
The end-to-end advantage of a PAC cleanroom: it’s a turn-key system that’s built for your validation needs. You tell us what you need, and we’ll bring it to life along with all of the critical cleaning supplies, furniture, and garments you’ll require on day one.
Every PAC cleanroom is certified by a third-party verification and includes any calibration requirements needed before delivery.
Have more questions than answers? Ask a PAC cleanroom specialist for help with your cleanroom build and get a free quote or consultation at no cost.
Medical Device Cleanroom Build Guide
Part 1: Walls, Windows, & Containment
Part 2: Electrical, Mechanical & Partitions
Part 3: Fan Filter Units – Ceiling Grids
Part 4: VCT Cleanroom Flooring
Part 5: HVAC Design & Fan Filter Integration
Part 6: Pressure Differentials, Humidity and Temperature Calibration
Part 7: Cleanroom ISO Class Validation
Our cleanroom specialists help you identify which components best suit your application with respect to ISO standards. Let’s help you select the right cleanroom components from thousands of options. Production Automation (PAC) is a factory-direct resource for modular, hardwall, or softwall cleanroom builds and components.
