On next Thursday, November 22nd, the FORUM A3P CLEANING BY DESIGN will be held in Barcelona (Gran Hotel Calderón). IWT will give a workshop entitled “Explore the benefits of cleaning automation”. The objective of this workshop is to assimilate the benefits of the introduction of fully automated cleaning processes, sharing experiences and discussing the main challenges that its implementation means for different applications (active principles, parts in contact with product, deposits and reactors, etc.). The workshop will be conducted in English by Luca Fumagalli, technical sales at IWT, together with Jordi Net from Netsteril.
Since its foundation in 2016, Netsteril is working to introduce new technologies and solutions in Spain to the growing demands for quality and productivity of the pharmaceutical industry. Netsteril is a representative and service partner of the company IWT Cleaning Excellence, an Italian manufacturer specialized in cleaning systems. IWT was born in the Tecniplast group as a subsidiary devoted to develop washing and drying machines for animal research laboratories, where cleaning is a fundamental problem. Today, after 20 years of experience, the company has a complete range of solutions developed specifically for the growing demand in GMP applications.
The pharmaceutical industry is beginning to assume that the processes of cleaning materials and process facilities, especially those that come into direct contact with the product, must improve and reach higher levels of quality. The only way to ensure this is through the implementation of automatic validatable processes. Manual cleaning methods can hardly achieve 100% reliable and reproducible results. Therefore, automatic cleaning equipment is now considered as necessary as any other equipment such as an autoclave or a filling machine by production and quality assurance managers.
The targets that any cleaning system must achieve are:
- Minimize the need for operators who may come into contact with active ingredients and / or chemical agents as well as simplify their tasks, thus improving their safety and hygiene at work
- Eliminate completely the possibility of cross-contamination between batches
- Reduce energy and water consumption
- Reduce the level of polluting effluents trying to consume less detergents and water
- Guarantee the reproducibility of the results (automation)
- Provide documented evidence of the compliance of the cleaning process (cycle report)
IWT offers a range of solutions considering all this. It has a great experience and a scientific approach on the questions intrinsic to cleanliness. This has allowed the company to develop his own technology and be a step forward to the needs of the industry. For example, in those things related to the protection of the environment. Using the mechanical force of water and temperature, an item can be cleaned with minimal water consumption and even eliminate the use of chemicals. The scientific approach allows the solution to be designed without further experimentation: the nature of the waste or dirt, its solubility, its resistance to mechanical action, its adhesion to the surface, the influence of flow and temperature, contact time and other variables are studied. These types of services are offered in pre and post-sale.
The elimination of dirtiness and/or debris is influenced by a series of variables that are related to each other and have a different specific weight depending on the case.
Mechanical action: According to the product to be cleaned, its design, material and dirt, can agree different techniques; but IWT is committed to high-pressure washing, which offers a very high performance. This requires a pump that drives water at high pressure (70 bar) to a hydrokinetic nozzle. These nozzles produce a concentrated jet of water that by means of an orbital movement goes covering the whole surface of around, cleaning it completely by the force of the impact.
Temperature: It is a fundamental parameter to achieve good cleaning results. With some exceptions, at a higher temperature, the greater the solubility and therefore, the shorter the cycle will be. The water is heated by heat exchangers or resistances and regulated by Pt-100 probes.
Chemical action: There is a wide variety of detergents, whether they are acidic, basic or neutral. They may be necessary or even indispensable in some applications but they have the problem of their elimination after the cycle to avoid cross-contamination. Rinsing with water should be monitored with conductivity probes or other analytical methods.
Time: In the pharmaceutical industry, raw materials of very different nature are used: solids, semi-solids, gels, creams and liquids that can be divided into: water-soluble or hydrophobic (insoluble). The cycle time will depend on the nature of the product, with the most soluble being the ones that are eliminated better and faster.
In short, addressing the automation of cleaning processes requires putting yourself in expert hands. Not only must the cleaning method be adequate but also the technology. Nowadays there are systems that allow to significantly reduce water and energy consumption and to carry out environmentally friendly cleaning processes that can be validated according to GMP. The production manager will do well to know them and adapt their requirements to promote the best results.