The many applications of cleanrooms: From medical cannabis to space pharmaceuticals

16 maggio 2024

Be it cannabis cultivation, pharmaceuticals production or laboratories in space – cleanrooms protect all manner of applications against two hazards: particulate and microbiological contamination. Cleanrooms are the only way to ensure the quality of numerous products and research projects. Cleanroom technology creates the conditions needed for innovation in a wide range of fields

Medical cannabis – another beneficiary of cleanrooms

The partial legalisation of cannabis took effect in Germany on April 1, 2024 – making this a good opportunity to take a closer look at medical cannabis. This has been a therapeutic option for patients in Germany ever since its medical use was first allowed seven years ago. For certified cultivation, however, cleanrooms are required.

The many properties of cannabis have been appreciated since ancient times, with a history stretching back to the Egyptians, Greeks and Romans. In the twelfth century it found its way into the writings of Hildegard von Bingen, where it was recommended for use against various ailments, including pain, nausea and rheumatism. Cannabis enjoyed particular success in the 19th century, when it became the most commonly sold substance in the chemists and pharmacies of the Americas and Europe [1]. However, no one really understood what it contained, how it worked, or what the best way to cultivate it was.

Medical cannabis offers an excellent example of why the best way to cultivate cannabis today is in a cleanroom. It goes without saying that cannabis is subject to the same requirements as are all other medications: the amount of active ingredient must be controlled and painstakingly documented so that the dosage can be precisely calibrated. Various rules and regulations must be observed here, in particular the monograph for cannabis flowers in the German Pharmacopoeia (DAB), Good Manufacturing Practice (GMP), and Good Agricultural and Collection Practice (GACP).

One of the objectives of these regulations is to prevent contamination with pests, mould spores or heavy metals throughout the cultivation process – from the cell culture until the plants bloom. According to GMP, this requires a special form of documentation that includes tests for various heavy metals, determination of the total bacteria count of aerobic micro-organisms, additional qualitative (and in some cases quantitative) proofs of specific micro-organisms, and the determination of the total bacteria count of yeasts and moulds. The control measures extend beyond the cultivation phase to encompass subsequent processing (e.g. drying processes).

These strict tests give rise to very particular requirements for climate control technology. In order to ensure that the active ingredient content remains constant, it is necessary to strictly control a whole range of factors – especially temperature, humidity, light, fresh air supply and airflow. This offers an additional advantage for cannabis growers, as it also maximises the yield. Even the water used to irrigate the plants is specially cleansed and filtered.

Standard-compliant components ensure quality

Many of these conditions are also characteristic of cleanroom technology, so it should be no surprise that satisfying the full range of regulations is best accomplished by working under cleanroom conditions, from the cultivation of the plants through to their packaging. That is why cleanrooms are an ideal location for the cultivation of “cannabis fields”, with the use of special environmental chambers that can be controlled through a platform using certified software, including the recording and archiving of data. An example is helpful here to illustrate the scale: two years ago, a cannabis producer in Switzerland commissioned a 1,100-square-metre production facility for the cultivation and processing of plants under controlled cleanroom conditions. This is equivalent to one-seventh of a football pitch