ISO monitoring
ISO monitoring is the monitoring of processes by automatically measuring and recording data. This usually means the systematic monitoring of pressure ratios, temperatures and, if necessary, relative humidity. In cases of doubt, this is also done with several sensors for the same parameter in order to obtain an overall picture or an average value for the room. In very rare cases, the particle concentration is also monitored automatically if it is very critical to the process. The measurement is carried out using permanently installed particle counters that draw in the air at the critical measuring points near the probe.
Of course, it is also possible to integrate almost any other monitored or controlled function into the data recording if required – the only question is whether this is necessary and sensible.
At Schilling Engineering, we use the same sensors for monitoring that are required for controlling the cleanroom. This minimizes the technical installation effort and therefore the costs. The aim is to use a system from one manufacturer in order to reduce 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, a so-called 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 for the validation of automated systems and ensures that these systems operate in a consistent and controlled manner to guarantee product quality.
Cleanroom-Monitoring in practice
The monitoring data forms the basis for the necessary proof of the actual production conditions and at the same time offers the opportunity to identify trends and ensure quality in the long term. Warnings and alarms are usually automatically forwarded to QA or other responsible parties via the system.
A monitoring system can be a stand-alone system that can also be retrofitted. Of course, it makes sense to provide appropriate cables and sensors when installing a new cleanroom in order to avoid downtime and wall and ceiling breakthroughs when retrofitting.
Data recording
The time interval for data recording is a frequently discussed topic. Do not choose intervals that are too short, but limit yourself to what is necessary. Check in advance what information and evidence is really needed. The evaluation of large amounts of data is time-consuming and requires a lot of storage space – and also significantly more of your working time for the evaluation.
