Big Blue Blog - Process Monitoring, Controls and Records

The cleanroom decontamination plant provides a critical service to manufacturing operations. Failure of correct garment supply can lead to shut-down of the operation or contamination of the product resulting in serious financial loss.

When patient safety is a risk then the potential for harm caused through a contamination control failure is even higher. For this reason the decontamination plant must be monitored and controlled to provide evidence and assurance that all operations are robust and products within specification. This is usually accomplished within the framework of a recognised and accredited QMS (quality management system). Monitoring and control systems are broadly based around two operational areas; 

1. Process and engineering controls
2. Cleanroom and product control

Process and engineering controls

Cleanroom decontamination operations require the use of industrial processing machinery and purified water systems.

These machines require regular maintenance to provide uninterrupted and consistent operation and a planned preventative maintenance (PPM) schedule is required with accurate PPM records retained for reference.

The wash and dry cycles are critical process points providing cleaning, disinfection, particle removal and drying. Control, monitoring and batch process information are therefore required for these stages.

SCADA (supervisory control and data acquisition) systems are used to achieve this degree of control and data collection.

The SCADA system will monitor critical parameters such as wash temperature, process time and conductivity. The drying cycle will also be monitored and the SCADA system can be used to adjust the process time according to the moisture content of each load. 

Alarm states will be set for all critical stages and failure to meet the specified parameter will result in an immediate alarm and automatic halt of the process. All key data, including any out of specification alarms, will be captured and stored for future reference.

Cleanroom and product controls

Testing is required to ensure that the decontamination plant cleanroom is operating effectively and within specification.

The unmanned (at rest) cleanroom will be tested and validated on a regular basis by validation engineers using the methodology specified in ISO 14644.

Further particulate monitoring will be carried out during decontamination operations to give an indication of the contamination levels present during operational (in use) conditions.

Pressure monitors will be in place to continuously monitor and record cleanroom overpressure.

The purified water system will also be monitored for its physical characteristics and microbiological loading.

Particulate and fibre tests will be carried out on sample processed textiles to confirm acceptable decontamination of products using either the Helmke drum test, IEST-RP-CC003.3 or the ASTM F51/00 microscopic test.

If control of viable particles is required then the decontamination plant cleanroom will be monitored during use for microbiological contaminants and the test methods recommended in the MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors are usually adopted.

When an additional sterilisation stage is required the process will be validated, monitored and certified by the sterilisation contractor. Microbiological sterility testing may also be carried out on finished product to confirm that the process is effective.

Cleanroom decontamination plant operations will be controlled by a documented system covering all aspects of the process.

This will include all critical areas such as staff training, changing procedures, access controls, cleaning procedures, records, validation and change control

Records

Monitoring and control systems operated by the decontamination plant produce a variety of results and records. These results are used to provide confirmation that the plant is producing products which meet the agreed specification and are suitable for cleanroom use. The records are also available for inspection during investigations, for example if there is a potential contamination issue either at the decontamination plant or the end use.