What you need to know before baking cupcakes in a lab
- Annelies Van fraeyenhoven
- Senior CSV & Lab Qualification Engineer
What if you used everyday kitchen tools like devices in the pharmaceutical industry? Senior CSV & Lab Qualification Engineer Annelies makes the comparison with a scale. Both in the most basic kitchen and in the best-equipped laboratory you will find a scale. Although not of the same type and budget, these devices do the same thing: determine the weight of something.
The purchase
Everything starts with the purchase of the new device.
Whereas you don't usually ask for a quote for a kitchen scale, in the pharmaceutical industry it most likely has to be purchased at a certain anticipated budget. This will require stakeholder approval and the list of requirements is undoubtedly a lot longer than for your kitchen scale.
Your lab purchase will be delivered and possibly installed by a technician and an IQOQ assessment implementation. This entails the necessary paperwork. In the kitchen, the 'installation' aspect is usually limited to inserting a battery.
The location
Your kitchen scale gets a convenient place on your countertop or in one of your cupboards, ready for use.
In the lab, commissioning of the pharma counterpart begins. This includes assigning an identification number, adding it to a database and determining a maintenance interval. The commissioning must also be approved by the appropriate persons or bodies, for example the owner of the relevant cost centre, quality assurance, the user and possibly even a safety department.
In the kitchen, it seems almost unthinkable to keep a list of every knife, fork, the serial numbers of your toaster and hand blender or the brands of your microwave oven and ladle.
In pharma, this of course happens, the new scale will also be added to this list. Remember that your lab scale will be serviced by a technician every so often.
Usage
Ready to get started in the kitchen? Turn on your scale and it's ready to use.
In the lab, on the other hand, the scale must first receive an initial calibration by a calibration technician using calibrated weights and measuring devices. Before any use, you verify the operation of the lab scale using a procedure and a (calibrated) set of weights. Only when you are sure that the scale measures within the predetermined percentages of accuracy can it be used.
The fact that everyone in the kitchen uses the scale slightly differently will not have a gigantic impact on the final result. The risk of misuse is also small. One person first turns on the scale, places a plate or tray and then adjusts to zero grams before weighing, say, flour. A second person may not respect this order and places the tray first before turning on the scale. One person places the scale on the countertop, another on the table or perhaps even on a towel.
There is no such freedom in the lab. Procedures are drawn up for use of the device, which every user will have to follow. In case of incorrect use, deviations will be written and any corrective actions taken. Misuse of the pharma scale can have major consequences for the final result. In addition, each use, the reason for use and the user's initials are indicated in an appliance-specific logbook.
Follow-up
The pharma scale buyer cannot yet sleep on his two ears if it is a computerised model. For this, a validation will have to be completed according to a strictly defined set of requirements and a strict plan.
Is the device broken or no longer needed? From the lab, you cannot simply take your scale to the container park. After any final calibration, this device will go through a decommissioning process. This too will have to be approved by various stakeholders.
Conclusie
With a pharma scale, you go through many steps. So if you want to make cupcakes and use a kitchen scale in the same way as a pharma scale, you're definitely several days away! 😉
