One of the pillars of the transition between the design of a project and its execution is the selection of equipment. It is very important to work together with the manufacturers of process equipment so that the final result of a project is in line with what was planned in the design phase. In this article we share what we consider to be the 10 main criteria that we like to take into account when helping our clients select equipment.
Type of process
This is both the most basic, simple and important. The equipment must always be the most suitable for the process being planned. This implies being clear about the process: the pharmaceutical form, the microorganism/cell line used (biotechnological processes), the stages of the process, the size of the lots, etc. For example: a process that uses animal cells will need different equipment than one that uses bacterial cells.
Manufacturer experience
The experience of the manufacturer or supplier is a guarantee of quality in the pharmaceutical sector. This is easily demonstrable in the form of references and it is a good practice to check some of them if you have not previously worked with equipment from that manufacturer. Let’s also remember that the final responsibility for a piece of equipment to comply with GMP regulations rests with the medicine manufacturer.
Flexibility
Flexibility in a team is very important, but it usually involves a cost: performance. The more multifunctional a machine is, probably the lower the performance when performing each of these functions individually. You have to know how to find the right balance between flexibility and performance taking into account the restrictions on the budget and the available space.
Equipment capacity
The production capacity of a piece of equipment must be aligned with the capacity of the rest of the line’s equipment (to avoid bottlenecks). In addition, it is important to take into account the needs of cleaning and maintenance (discussed in the following point) when calculating the capacity. A recommendation to keep in mind is that equipment is operated with a certain margin with respect to 100% capacity for unexpected contingencies.
Cleaning and maintenance
All equipment needs cleaning operations and preventive maintenance stops. These procedures must be taken into account when establishing the necessary equipment capacity and subsequently when planning production. For that reason, it is very convenient for the equipment supplier to include recommendations on cleaning systems and procedures and recommended preventive maintenance operations and their frequency. These two elements are vital to ensure the good functioning and durability of the equipment.
FAT/SAT tests and validation
The manufacture of a piece of equipment requires the completion of a whole series of checks by the manufacturer. These checks can be used later as documentation for process validations. The tests to which the equipment will be subjected to verify its correct operation should be defined jointly with the manufacturer, prior to the manufacture of the equipment. In order to ensure compliance with the URS (User Requirements Specifications) and to be part of the formal offer thereof. The checks carried out on the equipment should not be limited only to factors covered by the GMP. It is also advisable to carry out tests on the proper functioning of the equipment, which would fall within the framework of the GEP (Good Engineering Practices).
Level of automation
Any process equipment must have a level of automation according to process needs and in line with the rest of the production line/plant. In addition, the manufacturer must be able to integrate the equipment with the existing control software infrastructure in the plant. The way in which the process variables (CPP – Critical Process Parameters, CQA – Critical Quality Attributes and KI -Key Indicators) are recorded is critical to be able to apply the corresponding contextualization and genealogy, consume them correctly and extract knowledge.
Customization of the equipment
“Off-the-shelf” (or catalog) equipment is usually the cheapest and with the shortest delivery times. The more custom features requested from the equipment manufacturer, the higher the price and delivery time. It is very important to assess that it is really necessary at the level of personalization of a team, and those characteristics that do not fit completely with what was initially planned, but with which “you can live”. Asking many extras from the manufacturer can cause the price of a piece of equipment to skyrocket and be much higher than originally planned.
Ease of use
Sometimes we can forget to take into account the operation of the equipment on the part of the users when evaluating an election. An equipment must be easy to use and intuitive for the operator since this helps to avoid human errors. Unjustified complexity is not good in a production plant.
Costs and delivery times
It is important to get advice from experts with experience in the biopharmaceutical sector who can help determine if the price offered by a manufacturer is in line with its characteristics and services compared to the rest of the equipment on the market. In addition, it is advisable to contact several suppliers to be able to compare the different options and conditions offered.
Some process equipment may take more than a year to manufacture, test and deliver; and, later, be validated until they are operational to produce. The manufacturers must be contacted sufficiently in advance and ensure that the expected delivery dates are in accordance with the project schedule.
If you are interested in learning more about process equipment selection and how we can help you, contact us: klinea@klinea.es
