ISO Monitoring

ISO monitoring refers to the monitoring of processes by automatic measurement and recording of data. This usually involves the systematic monitoring of pressure conditions, temperatures and, where appropriate, relative humidity. In cases of doubt, this may be done using multiple sensors for the same parameter to give an overall picture or an average for the room. In very rare cases, particle concentration is also monitored automatically if it is very critical to the process. This is done by means of permanently installed particle counters, which suck in the air at the critical measuring points close to the probe.

If required, it is of course possible to integrate almost any other monitoring or control function into the data recording - the only question is whether it is necessary and useful.
At Schilling Engineering, we use the same sensors for monitoring that we use for controlling the cleanroom. This minimises the technical installation effort and therefore the costs. The aim is to use a system from one manufacturer in order to reduce the number of interfaces.

The recorded data can then be archived by our customers for documentation purposes using various manual and automated methods.

GMP Monitoring

The main difference between GMP monitoring and ISO monitoring is that the data must be recorded in a 'tamper proof' manner. On the one hand, this means that a completely independent monitoring system (independent of the room control system) must be set up or installed. On the other hand, an audit trail is required. This means that special attention must be paid to the monitoring of change and deletion processes, e.g. in the form of databases, etc.

In the GMP environment, the design of monitoring software is governed by the GAMP 5 (Good Automated Manufacturing Practice) guideline. This guideline provides a structured approach to the validation of automated systems and ensures that these systems operate in a consistent and controlled manner to ensure product quality.

Cleanroom monitoring in practice

Monitoring data provides the basis for the necessary proof of actual production conditions, as well as the ability to identify trends and ensure quality over the long term. Warnings and alarms are usually automatically passed through the system to QA or other responsible parties.

A monitoring system can be a stand-alone system or can be retrofitted. Of course, it makes sense to provide the appropriate cabling and sensors when installing a new cleanroom, to avoid downtime and wall and ceiling breakthroughs when retrofitting.

Data Logging

The time interval for data collection is a frequently discussed topic. Do not choose intervals that are too short, but limit them to what is necessary. Consider in advance what information and evidence is really needed. Analysing large amounts of data is time-consuming and requires a lot of storage space - and a lot more of your working time for analysis.