4 July 2024
Preparing Medicines in an Innovative Cleanroom – Hospital Pharmacists
Hospital pharmacists play a crucial role in healthcare; they not only provide advice to patients and healthcare providers but also produce medications that are dispensed to patients. To meet PICS standards for hospital pharmacies, the production of medications is carried out in specially designed cleanrooms. This controlled environment is essential to meet hygiene and quality standards.
Using a cleanroom as the Foundation for Meeting PICS Standards
A cleanroom is a specially constructed production environment designed to minimise 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?
Cleanroom Technology and Validation
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 micrometres or larger. The result? A constant flow of clean air, minimises 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.
MoVE
A team dedicated to analysing, testing, and validating cleanrooms? Meet our MoVE team
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. Minimising 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 Behaviour Training
Working in a cleanroom requires specific behaviours 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 minimise 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.
New Standards for Hospital Pharmacies
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Normec Advipro
Lille Belgium