Misterium®: mini sterile room

Technical file

Type of innovation: System
Scope: Hospital Pharmacy; Bioengineering
Innovation leader: Shared leadership
Year: 2000
Period: 1972-2002
Geographical scope: International
Economic impact: Medium
Level of innovation: Evolutionary
Patent: Yes
Interdisciplinary connections: -

Preventing contamination

In the 1990s, hospital pharmacy was not yet subject to any standardized regulation of hospital compounding procedures. Instead, each center had its own methods.

A fatal incident in a Chilean hospital, caused by the contamination of compounds produced in the pharmacy, led the country's authorities to introduce groundbreaking legislation, establishing a series of mandatory requirements and conditions for these procedures. Grifols subsidiary in Chile offered the health authorities its expertise in the preparation of samples, and worked with hospitals to develop a technological solution to prevent the possibility of such contamination. Other countries soon followed suit and took steps to regulate these procedures.

Misterium®, a cleanroom kit

Misterium® is an innovative modular cleanroom system born out of that initiative of Grifols Chile subsidiary in 2000. The name ‘Misterium' came about from blending the words "mini sterile room". A prime advantage is that it is quick and easy to build. It is designed so that the maintenance staff of any health center can install it without the need for costly work or projects by simply following the instructions (rather like ready-to-assemble furniture). The Misterium® kit has been a huge success, though hospitals tend to prefer a specialized technician to take care of installation, no matter how straightforward. However, the fact that the product is designed with this modular philosophy in mind means it delivers a highly versatile and adaptable solution.

Ready-to-assemble panels are produced according to the client's specifications, facilitating the installer's job and cutting out the work required by other types of solution. This means that hospitals do not have to interrupt activity because of installation. Misterium® can be ready for certification and operation in just 45 days.

Multiple applications

The system has multiple applications in pharmacy and laboratory settings, and can be used in any situation that requires an enclosed, segregated, pressure-controlled and easy to clean environment. Its walls, ceilings and floor are made of corrosion-resistant material capable of withstanding regular cleaning with antiseptics. There is an anteroom for users to change clothes, and a workroom. Pressure-controlled air filtering systems can be installed, plus any accessories and equipment depending on the end use, be it preparation of sterile medicines or doses of parenteral nutrition, cytostatic drugs, or gene therapy. And it all complies with room classifications (B, C or D) and with the relevant regulations, both in Europe and in the United States.

Grifols Engineering also offers bespoke design and adaptation of Misterium® rooms to fulfil specific purposes in different sectors of activity. It has proven to be an innovative market pioneer and a great success, so much so that many other companies have copied it. Demand for this solution is particularly strong in those industrial, hospital, pharmaceutical, or research activities that require small areas which are free from particles and microorganisms.

At present, over 150 certified Misterium® rooms are in operation in industrial and hospital environments in Chile, Spain, Portugal, Mexico, the United States, and Italy. Providing the market with cleanrooms has strengthened the Hospital Division's Inclusiv® compounding portfolio. Grifols is the only supplier of pharmaceutical preparation systems that not only provides software and hardware but also delivers and assembles the facility where medicine preparation will take place.