Third week of attachment - Production

University Medical Centre of Groningen has its own production department, which produces medications for their patients under certain circumstances:

1. When the drug or formulation needed is not available in The Netherlands and Europe

2. Orphan drugs - too few patients need the medication and there are no pharma companies

producing it

3. Pediatric medication - no commerical products with the desirable dosing

4. Cytostatic drugs which are unsafe to produce in the wards

5. Diagnostics - tracers e.g. isotopes

6. Drugs for trials - pharma companies may not want to produce the drug and the placebo

Ok enough of the facts. Presenting to you the production area of the hospital!

On the left is the big tank that produces water for injection (WFI), which is monitored 24 hours to control quality of the water. On the right are some bottles used for different products.

The production area follows Good Manufacturing Practice (GMP) rules closely. The sign shows BLACK ZONE in Dutch, where labcoat must be worn.

See, I wore my coat!

And Mandy pretends that she hasnt got hers on :)

Tank for washing of bottles before they are filled. WFI is used for the washing and the water is filtered. Notice the filter housing which is connected to the tube.

Still in the Black zone... autoclave for terminally sterilzed products!

Some equipment are sterilized here too. The autoclave operates uni-directionally, things go in here and come out from the door on the opposite side of the autoclave, to avoid contamination.

And the pharmacy assistant really opened the autoclave like this! Of course he was much more professional :)

Mad-ny at the control panel of the filling line. Don't push the button!

Ok let's get to work. Personnel have to gown up in a GREY zone to enter the clean room or sterile production area. A Grey zone is also used to transport materials from the black zone into the white zone:

Here is one of the platforms used to transport materials. GRIJZE ZONE is of course, GREY ZONE in Dutch.

And we enter into the WHITE ZONE...

Where a pharmacy assistant is at work! Notice her overall suit, hairnet and mask. Plant shoes are also worn in the sterile preparation area. The fume hood has laminar air flow which constantly blow air out (towards the technician) so as not to contaminate the product.

The white infusion fluid on the right is total parenteral nutrition that is produced here. The white colour is brought about by the lipids present in the infusion.

This shows the sterile production area, where infusions and eyedrops are produced.

By the way, the clocks in the production area are always one hour late in summer as the staff have not adjusted them after daylight saving last October. It should be 9.46am already!

Compounding tank in the sterile production area, where large volumes of solutions are mixed for filling into bottles or ampoules.

The ampoule man :)

He fine tuned the ampoule machine according to their sizes, fill volume, positions, etc. The ampoules are supplied sealed, the machine melts the mouth to open it, fill, and seal is by twisting like what we did at the lab. Of course many times faster, hence the product is exposed for only seconds and chance of contamination is very low!

The galenicals are produced here! Products include tablets, capsules, suppositories, solutions, syrups, ointments, creams, i.e. everything that's non-sterile.

The tablet coating machines

Visual inspection station, where products and labels are checked before release.

There are large scale production and production for individual patients. Large scale production is not so large, maybe 20 to thousand bottles, but some products have been in production for many years in the hospital and the hospital would not function like how it does now without the medications produced here.