Preparing Medicines in an Innovative Cleanroom – Hospital Pharmacists
Ziekenhuisapothekers spelen een cruciale rol in de gezondheidszorg; ze staan niet alleen klaar met advies voor patiënten en zorgverleners, maar produceren zelf ook geneesmiddelen die verstrekt worden aan de patiënten. Om te kunnen voldoen aan de PICS normen voor ziekenhuisapotheken, is het produceren van geneesmiddelen aangewezen in speciaal ontworpen cleanrooms. Deze gecontroleerde omgeving is essentieel om te beantwoorden aan hygiënische en kwaliteitsnormen.
Using a cleanroom as the Ffondation for meeting PICS standards
A cleanroom is a specially constructed production environment designed to minimize contaminated particles. Sterile pharmaceuticals such as vaccines can only be produced in this manner. However, production in a cleanroom alone is not sufficient; stringent standards must also be met during both the construction and ongoing operation phases.
The design and construction of a cleanroom
To comply with the new Royal Decree on the preparation and dispensing of medications, and their distribution within healthcare facilities, a well-equipped cleanroom is the first step. But how should such a cleanroom be constructed exactly?
Advanced Air Filtration
One of the key components in cleanrooms is advanced air filtration. HEPA filters are capable of removing the smallest particles, 0.3 micrometers or larger. The result? A constant flow of clean air, minimizing the risk of contamination.
Monitoring systems
A cleanroom provides a controlled production environment, supported by modern monitoring systems to oversee factors such as temperature, humidity, and air quality. Any values detected outside the norm can prompt swift corrective action.
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Cleanroom Design
When designing a brand-new cleanroom, it's crucial to select materials that are easy to clean and disinfect. This applies to floors, walls, workspaces, and surfaces. Minimizing edges and corners reduces areas where dust and particles can accumulate.
Meeting Cleanroom Usage Standards
Adhering to current regulations is vital when designing and constructing a new cleanroom in hospital pharmacies, but that's not all. Proper user training, maintenance, and cleanliness within the cleanroom, along with clothing regulations, ensure compliance during operations. Continuous monitoring of regulations and standards is essential for the quality and safe production of medications.
Cleanroom Behavior Training
Working in a cleanroom requires specific behaviors and adjustments. Continuous training of personnel is therefore crucial. Pharmacists must be familiar with the latest technologies to produce medications of the highest quality.
Maintenance and hygiene
A cleanroom is designed for controlled production environments, necessitating adherence to proper cleaning procedures. Additionally, periodic deep cleanings are essential to minimize the risk of contamination.
Clothing Regulations
Strict clothing regulations must be followed before entering a cleanroom, including sterile coveralls, gloves, masks, and more. This prevents contamination from outside the cleanroom.
Need support for your cleanroom project?
Struggling to meet the strict standards and regulations while working as a hospital pharmacist in a cleanroom? Our experts provide support through project support, consulting, or training on cleanroom protocols.