What is a GMP washing machine?
In pharmaceutical industry, automatic cleaning is usually associated with the acronym CIP (Cleaning In Place) and certainly, CIP systems are very common in applications such as tanks, reactors and others. On the other hand, the acronym COP (Cleaning Out of Place) is not so much well known. GMP washing machines are the genuine COP equipment, but in our country these devices are not as widespread as one would expect. Why there is not enough effort being made in COP automation?
There may be several reasons that would explain this situation. I suspect that one is a certain lack of knowledge about the state-of-the-art technology. When you think of a washing machine for contact parts, many times we assimilate it to what a dishwasher can do. E.g. small parts such as tablet punches, dosing pumps and nozzles, and above all, glass containers and instruments. There is also some belief that cleaning of parts with complex shapes requires the flexibility and dedication of manual washing and that it is very difficult to automate. The truth is that GMP washers are much more complex than a professional dishwasher and they offer custom made solutions for multiple parts in the same cycle, from containers of all types, sizes and shapes to hoses, pieces and utensils.
Another aspect that slows the investment is the price issue. These are ancillary equipment, non-directly productive and when investments are planned, they are always a second priority. Sometimes, when they are considered, they are wrongly compared with other product categories like laboratory washing machines and budgets are not properly managed.
In order to properly approach the matter of cleaning automation in pharma, we should understand the advantages and benefits that the GMP washers are offering.
Know the benefits and return on investment
Since it is not production equipment but ancillary, we should assess the savings it could provide in terms of operating costs. A short list of them could be:
- Savings in hours of personnel dedicated to manual cleaning. Release from tedious, repetitive and little value tasks.
- Savings in training and qualification of personnel. Elimination of the rotation problem.
- Saving for lowering the frequency of inspections by supervisory personnel.
- Savings in the use of consumables: detergents, tools, clothing and EPIs of operators (about 1/3 or 1/4 of the costs in manual).
- Savings in energy and water consumption (PW and WFI)
- Increase of productivity due to reduction of down time due to cleaning of parts.
The advantages of automation
Investment in GMP washers provides other improvements, especially related to quality assurance and labour safety. These are:
- Reliability. In a manual process, after training, we must rely on the execution by the operator; its discipline and rigor in carrying out the task according to the validated protocol. These two qualities cannot always be properly monitored. Instead, automatic equipment works with recipes; a set of parameters that make up a cycle, with a continuous monitoring of critical parameters which are fully reproducible and, therefore, validatable.
- Flexibility. Contrary to what people believe, GMP washing machines have great flexibility in terms of cleaning parts or design of pieces and can process a wide variety of materials in the same cycle. From containers to hoses, connections and parts of very diverse nature: steels, plastics, resins, rubber and others. Production can be organized straight forward in batches and adjusted to the process.
- Efficiency. As mentioned, automation allows you to optimize consumption; both due to the amount of water, detergents and energy needed and due to reduced cycle times. In addition, it allows to ensure the proper drying of the load, an important issue since water residues over the cleaned components can favour microbial growth.
- Safety and ergonomic. Working with washing machines allows limiting the risks arising from the manual cleaning of contaminated parts. Operator exposure is eliminated according to what types of chemicals. Cleaning can also pose risks due to the use of hot water, detergents or even steam.
- Compliance. GMPs advocate that everything that is automatable should be automated. The reason is very simple; the ability of a machine to always reproduce the same and in the same way is always superior to that of a person.
In order to prepare the investment, and to ensure a correct budget allocation, it would be necessary to prepare the URS in which the different stakeholders should participate; engineering, maintenance, production and quality control. By incorporating all these perspectives, we assure that the project will be developed properly, without last minute surprises.
In general, there are three major issues that should be very well resolved before starting and budgeting a GMP washer installation project:
- Identifying and grouping the parts to be washe: Unlike what is commonly believed, there are very few products that cannot be washed with a GMP washing machine. From critical parts in contact with the product such as format pieces (punches, dies,…), containers (IBCs, drums, mixing containers, …) to production components (valves, housings, hoses, etc.) and accessories (freeze drying trays, carrousels, etc.). Parts washing are done by batches or loads with a specific cycle. To ensure proper cleaning of each part, it is necessary to transmit them to the supplier. From here, the most appropriate chamber size is selected, and load racks are designed to adapt to the load. The design of racks is not only for support purposes, they are custom designed using 3D scanning technology.
3D scanning process for the design of the rack
Thanks to the custom design, the placement of the parts is univocal, ease and intuitive, ensuring proper coverage during washing and full drainability.
Rack 1: Dosing pumps, injectors, storage tank and others
Rack 2: Valves, connectors, hoses, intermediate tanks and others
The rack, by itself, is piping system that, by means of quick coupling devices and multiple injection points, injects pressurised jets of water to the internal surfaces of the parts to be washed, cleaning by mechanical, chemical and temperature effect.
Detail of the cleaning rack. Note that it has a quick connection port to a water/fluid utility and that there are a series of holes that inject water highly pressurised towards the surfaces of the load
- Degrees and types of residues. In general, you have a good knowledge of the residues that your products entail since it is already being cleaned manually. Possible contaminants such as residues of active ingredients or excipients, residues of lubricants or detergents, microbial load, etc. may require specific solutions.
- Location of the equipment. Ensure that the dimensions of the equipment and the architecture of the room are compatible. The washing equipment is usually very compact and requires a footprint quite reduced with respect to its load capacity but still has a significant size and the rooms are not always provided for this type of equipment. It is also necessary to consider the services for the operation of the equipment, especially those more critics such as the WFI that may entail a significant additional cost.
Comparative table between manual vs automatic cleaning