This is the ‘heart’ of Pharma Nord’s production plant in Vojens. Here, all the different raw materials are converted to tablets and capsules under tightly controlled conditions. In order to ensure full traceability, every single production is supplied with a unique batch number.
Before entering the production area, you are guided through a locker room and instructed to put on a gown (white coat), a hair net, and clean footwear. Furthermore, you are instructed to carry out a thorough hand wash.The entire production area has slight over pressure in order to prevent polluting particles on the outside from entering.
The entire production staff must use gloves at all times when carrying out manufacturing processes that involve direct contact with the products, for instance, weighing and taking out samples.
The first room is for mixing tablets. Here, we mix the different ingredients in accordance with a long list of standard procedures that we control thoroughly throughout the entire process. We pour the powder into a mobile container which can move to the next machine where we either press the powder into tablets or fill it into hard capsules.
Afterwards, we coat the tablets with a protective layer that extends their shelf life and makes them easier to swallow. Certain tablets must even have a special colour, either for the sake of protecting the active ingredients or to make them easy to recognise.
The Production Department also manufactures different types of capsules. Pharma Nord’s specialty is the manufacturing of soft gelatin capsules in different varieties. The active ingredients are mixed in an oil solution and encapsulated in soft gelatin.
During the manufacturing we measure and verify the content, while also making sure the gelatin shell has the correct thickness. We document all of this at time intervals during the production. Upon completion of the capsules we also control this by means of a random sample in Pharma Nord’s own laboratory.
Once the assembly of the capsules is complete they pass through a series of chambers that serve as tumble dryers. Afterwards, we collect the capsules in large plastic trays and place them in a special drying compartment for another day or two. We sort the dry capsules and discard any which are the wrong shape or size. The rest of the batch is now ready for packaging in large plastic bags which we quarantine until the completion of quality control.
During the actual production, several control procedures help to ensure that everything is on track. Once we complete each production, we thoroughly check each capsule and/or tablet in terms of weight, content, dissolution time, etc.
At the same time, we go through all control documents to ensure that we carry out procedures correctly. The production of one single preparation involves filling in as much as 32 different control documents.
After each round of production we clean the machines. This effectively removes any trace of the former product and prepares the machine for the next production. The cleaning procedure is very time-consuming. In fact, the cleaning routines are that tedious it may take between 6 and 24 hours to prepare one single machine for the next round of production.
All cleaning procedures in the production area go through validation. This proves the product’s efficacy and means that no products face exposure to contamination. There are checklists to document and control the cleaning.