One of the cornerstones of the transition between project design and execution is equipment selection. It is very important to work together with process equipment manufacturers 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 top 10 criteria we like to take into account when helping our clients select equipment.
This is both the most basic, simple and important. The equipment should always be the most suitable for the process being planned. This means being clear about the process: the dosage form, the micro-organism/cell line used (biotech processes), the process steps, the batch size, etc. For example: a process using animal cells will need different equipment than one using bacterial cells.
Experience of the manufacturer
The experience of the manufacturer or supplier is a guarantee of quality in the pharmaceutical sector. This is easily demonstrated in the form of references, and it is good practice to check some of them if you have not previously worked with equipment from that manufacturer. It should also be remembered that the ultimate responsibility for equipment to be GMP compliant rests with the manufacturer of the drug.
Flexibility in equipment is very important, but often comes at a cost: performance. The more multifunctional a machine is, the lower will be the performance of each one of the individual tasks. The right balance between flexibility and performance has to be found, taking into account budget and space constraints.
The production capacity of a piece of equipment must be aligned with the capacity of the other equipment in the line (avoid bottlenecks). In addition, it is important to take into account cleaning and maintenance needs (discussed in the next point) when calculating capacity. A recommendation to take into account is to operate the equipment with a certain margin with respect to the 100% capacity for unexpected contingencies.
Cleaning and maintenance
All equipment needs cleaning operations and preventive maintenance shutdowns. These procedures should be taken into account when establishing the required capacity of the equipment and subsequently when planning production. For that reason, it is highly desirable that the equipment supplier includes recommendations on cleaning systems and procedures and recommended preventive maintenance operations and their periodicity. These two elements are vital to ensure the proper functioning and durability of the equipment.
FAT/SAT testing and validation
The manufacture of equipment involves a series of verifications to be carried out by the manufacturer. These verifications can then be used as documentation for process validations. The tests done to verify the correct operation of the equipment should be defined together with the manufacturer, prior to the manufacture of the actual equipment. In order to ensure compliance with the URSs (User Requirements Specifications) and form part of the formal offer of the equipment. Equipment testing should not only be limited to factors covered by GMP. It is also advisable to carry out tests on the operation of the equipment itself, which would fall within the framework of GEP (Good Engineering Practices).
Level of automation
Any process equipment must have a level of automation commensurate with the 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 plant’s existing control software infrastructure. 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 contextualisation and genealogy, consume them correctly and extract knowledge.
Off-the-shelf equipment tends to be the most cost-effective and with the shortest delivery times. The more customised features that are requested from the equipment manufacturer, the higher the price and the longer the delivery time. It is very important to assess what is really necessary in terms of customisation of a device, and those features that do not fit with what was initially planned, but that can be “passed”. Asking for a lot of extras from the manufacturer can make the price of a device skyrocket and be much higher than initially planned.
Ease of use
Sometimes we may forget to take into account the operation of the equipment by users when evaluating a choice. Equipment should be easy to use and intuitive for the operator, as this helps reduce human errors. Unwarranted complexity is not good in a production plant.
Costs and delivery times
It is important to seek advice from experts with experience in the biopharmaceutical sector who can help determine whether the price offered by a manufacturer is in line with its features and services compared to other equipment on the market. In addition, it is advisable to contact several suppliers in order to compare the different options and conditions offered.
Some process equipment can take more than a year to be manufactured, tested and delivered, and then validated until they are operational for production. Manufacturers should be contacted well in advance and ensure that expected delivery dates are in line with the project schedule.
If you are interested in finding out more about process equipment selection and how we can help you, please contact us: email@example.com
- Posted by Klinea
- On 30 March, 2022
- 0 Comments