Cleaning methods

 

The effectiveness of a wash (or water cleaning) results from chemical actions of the product (breaking the links at the surface / dirt interface) and mechanism (removing dirt). The effectiveness of each of these actions is proportional to the time, duration and exposure to treatment, but they are inversely proportional to each other:

The more intense the chemical action, the less powerful the mechanical action will be for the same threshold of guaranteed cleanliness and vice versa.

  • Chemical action: wetting, soaking, dipping, spraying, spraying, liquidification …
  • Mechanical action: wiping, brushing, friction, blowing, suction …

 

Washing is an essential operation in the production cycle of active ingredients and pharmaceutical products.

However, the GMP recommendations or legal obligations that strictly define cleaning operations, particularly with regard to minimum water quality used in the processes, must be understood and incorporated into the design, in order to choose the appropriate techniques and equipment.

The optimisation of chemical and mechanical action will be achieved thanks to the expertise and work on basic parameters such as concentration, temperature, output, time and repeatability.

The choice of a washing medium should be made based on the input data (state of contamination) and output data (necessary requirements, results …).
In accordance with this data, the most appropriate means must be considered and then a move made towards optimisation of parameters of efficiency.

Firstly, concerning technology: High and Low Pressure pharmaceutical washer. Manually, friction is influenced by the pressure, the angle of attack and the link between abrasion and interface.

  • The higher the pressure, the lower the flow rate (for economic reasons)
  • The higher the flow rate, the lower the pressure (more traditional).

 

It should be noted that today 80% of industrial processes are in low pressure, but in recent years the proportion of high pressure processes has been increasing.

In terms of production procedures and routines:
Manual procedures and automated programmes (number – duration – sequences of successive phases ….)

In terms of equipment design:
Pharmaceutical washer, either static or mobile,
CIP Cleaning In Place

In terms of quality of resources used:
Finishings ensuring reproducibility (geometry, assembly, sealing)
Tilt, dead legs

This therefore allows the selection of the most appropriate equipment …