Cleaning is the first step in manufacturing!

Cleaning is the first step in manufacturing!

The legislator has expectations of the company regarding cleaning. Content related to this can be found, for example, in the AMWHV in § 5, Operating Rooms and Equipment, in § 6, Hygiene Measures, or in § 12, Personnel in managerial and responsible positions.

It must be specified when and to what extent equipment or parts of equipment need to be cleaned. All assembly and disassembly steps directly related to cleaning should be described in detail in instructions (SOPs). Critical areas on equipment that are difficult to access during cleaning or hard to see during subsequent inspection should be noted, and their cleaning and inspection should be reinforced through training. Drawings or images marking these critical areas increase the success of training.

Cleaning procedures must be validated!

All cleaning procedures for equipment with surfaces that come into contact with the product are validated. According to PIC/S PI 006, Chapter 7.3.1, "... only cleaning procedures for equipment surfaces with which the product comes into contact" need to be validated. However, it makes sense to also consider areas with which there is no direct contact but where the product could migrate.

Planning a cleaning validation involves considering how it should be carried out, how tasks are distributed, who is responsible, and to what extent the cleaning validation is determined based on risk. Furthermore, it is necessary to question how the validation status is checked and maintained with appropriate measures. This involves a multitude of tasks that can only be handled by a team, especially since they need to be continuously monitored over a longer period.

Cleaning should be considered from the very beginning!

The type of cleaning depends on the type of contamination. This undoubtedly trivial statement involves knowledgeable, detailed consideration of the production processes. For the product, this means that during the development stage of the product and the plant design (!) and the selection of a suitable cleaning process, consideration should already be given to later cleaning under production conditions.

What is involved in a cleaning validation? Important keywords include, for example:

• Selection of the guiding substances, limit values, and acceptance criteria for the guiding substances
• Limit values and acceptance criteria for microbiological contamination
• Limit values and acceptance criteria for cleaning agent residues
• Selection of one or more sampling methods
• Selection of sampling materials and auxiliary tools
• Selection and designation of representative sampling locations
• Selection of the analytical method
• Sampling

Would you like to learn more about cleaning and cleaning validation?

If you attend the seminar on Cleaning and Cleaning Validation with workshops and practical training for pharmaceuticals and active ingredients on October 9-10, 2012, in Binzen near Basel, you can expect a diverse event that combines theory and practice. Not only lectures will be held, but also numerous workshops will be offered. The practical part takes up a significant portion. The seminar is comprehensive and intensive, yet there is plenty of time for discussions and exchange of experiences on both days.