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cGMP Compliant Cleaning System Critical for Pharma and Biotech
- Florian Uffinger,Managing Director, alphaphoenix GmbH
The author emphasises on the necessity for the pharma and biotech industries to utilise equipments for the purpose of cleaning as also standardise this operation in order to comply with the current stringent cGMP norms.

Today, pharmaceutical and biopharmaceutical companies are faced with the challenge of ensuring that their products are of consistently high-quality on a permanent basis. In fact, these are set out unambiguously in national and international regulations.

In Germany, for example, the law stipulates that it is prohibited to manufacture or bring to market products or active ingredients whose quality is significantly reduced due to deviation from the recognised regulations.

Combine this challenge with the monitoring process and, most importantly, the detailed documentation of every processing step in the chain of production. This includes the cleaning of the equipment and materials which are used. Hence, a validated washing process for production equipment, containers and machines is an essential prerequisite if one is to fulfil these quality requirements.

Risk: The Human Factor
Companies where production machines, other equipments, or containers are still cleaned by hand often find it difficult to meet the requirements of a consistently GMP-compliant production process, because carelessness or simple human error can impair not only the cleaning process itself, but also the necessary documentation.

In situations such as this, the quality of the cleaning medium, various safety aspects and in particular the human factor are so difficult to monitor that it is almost impossible for an efficient and safe cleaning process to be carried out with clearly reproducible results. There is no question that the complex Standard Operating Procedures (SOPs) cannot be met with manual cleaning, or can only be met subject to certain restrictions. However, these require a lot of training and are time-consuming.

Using a special machine to standardize cleaning is therefore the logical conclusion, in order to structure the washing process in a safer and more effective way. By automating the entire procedure, a reproducible, documented cleaning process is achieved which will ultimately also increase product quality and safety, and result in less rejects.

Thanks to its design, a washing machine always delivers the same results; and the machine itself also handles the documentation of the cleaning process, while providing seamless, traceable transparency for authorities and consumers.

Costs and Processing Time Reduced
In a cGMP-compliant cleaning system, all the important process parameters are monitored and documented, meaning that every step in the cleaning process is completely traceable and reproducible. For example, a system monitors the cleaning temperature and the time required for this process, or it can measure the conductivity of the water during the final rinse. With a cGMP-compliant cleaning system, the operator can rest assured that the same high-quality cleaning of production parts is being achieved from day-to-day.

This is achieved through the self-draining pipe work and washing cabinet, through the surface quality of these, and through the crevice-free and dead-space-free design of the area that is in contact with the product, and of the entire cleaning cart. This type of construction optimises the cleaning process so that the desired cleaning result is achieved more quickly and with reduced water consumption.

The cGMP-compliant system design of a cleaning unit ensures an efficient cleaning process with fewer cleaning steps, and therefore saves water, especially expensive ultra-pure water, in the final rinse. An example of such a system is the latest development of ACG Value Links’ partner alphaphoenix GmbH: the PW6474 cleaning system which consumes as less as 32 litres of fluid per cleaning step.

As ultra-pure water in particular (PW, WFI...) represents a significant cost factor, an economical use of this manufacturing resource will lower costs for the company. The reduced water consumption combined with a highly efficient drying system has another advantage as well - it reduces the overall processing time because the time taken for filling, heating and draining is reduced due to the smaller water volume, too.

Validation Comes First
In order to meet the cGMP requirements for cleaning, at the start of a wash process the entire process has to be validated in the automated cGMP-compliant cleaning system. This takes place with the help of various testing procedures, such as the so-called “riboflavin test”, the “swab test”, and taking a sample of the water from the final rinse, which is tested in the laboratory for eventual residues. The “riboflavin test” checks whether all of the items’ surfaces to be cleaned are sufficiently wetted with the wash fluids with the help of a fluorescent substance. Considering the selected parameters such as cleaning elements, cleaning process or the geometry of a cleaning item a verification as to whether the test solution can be completely removed by the cleaning medium.

If the predefined acceptance criteria is met in this test procedure, and confirmed that using the defined process relevant parameters always the same result is obtained, the process is validated. The PLC-controlled machine consistently grants reproducible and documented cleaning processes.

Companies using validated cleaning units are therefore optimally equipped for the future. The automation of the cleaning process, by means of a cGMP-compliant cleaning system represents a solution which is convincing not only in terms of increased process reliability and reduced water consumption, but also because of its ease-of-use and smooth integration into existing production processes.

For more information about pharmaceutical, biopharmaceutical and packaging solutions, visit ACG Value Links’ booth no. H34 + I34 in hall no. 5 at P-MEC India 2013.