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GMP Particle Limits: Definition, Importance, and Solutions with Operio Clinic

Standards and solutions for UFA and galenic laboratories of hospital pharmacies.

What Are GMP Particle Limits?

The particle limits described in Good Manufacturing Practices (GMP) are essential parameters to ensure sterility and safety in UFA (Unità Farmaci Antiblastici) laboratories within hospital pharmacies. These strict standards ensure that prepared medications are free from contaminants, thus protecting the health of patients and medical staff. To comply with these regulations, existing air ventilation and control systems often need to be enhanced.

Operio Clinic: The Mobile Solution for Particle Control

Operio Clinic is an advanced air purification system specifically designed to drastically reduce airborne particle concentrations. This device is ideal for improving air quality in critical environments such as UFA laboratories and hospital pharmacies.

Key Features of Operio Clinic

• HEPA 14 Filter: Eliminates 99.995% of airborne viruses and bacteria, ensuring a sterile environment.

• Positive Pressure: Creates positive pressure in the room, preventing the entry of external contaminants.

• UVC Filter: Instantly deactivates residual microorganisms, further improving air sterility.

• High Airflow Rate: Filters up to 480 cubic meters of air per hour, ensuring optimal ventilation.

Advantages of Operio Clinic for Laboratories

• Increased Air Exchange Rates: In an average laboratory (approximately 35 m³), Operio Clinic achieves 13 additional air exchanges per hour, ensuring compliance with GMP standards.

• Easy Installation: The device is mobile and requires no structural modifications; simply place it in the room and plug it into a power outlet.

• GMP Compliance: Contributes to meeting the required particle limits for laboratory safety.

Applications of Operio Clinic

1. Hospital Pharmacies: Ideal for handling and preparing sterile medications.

2. UFA Laboratories: Optimizes air quality in environments where antineoplastic drugs or other sensitive compounds are handled.

3. Bacterial and Viral Load Control: Reduces the presence of contaminants, minimizing risks for staff and patients.

Why Choose Operio Clinic?

Operio Clinic is a versatile and technologically advanced solution, indispensable for laboratories and hospital pharmacies that need to maintain high sterility standards. With its ability to eliminate airborne particles and ensure a GMP-compliant environment, it is the ideal tool for protecting staff and patients.

Learn More

Would you like to know how Operio Clinic can improve safety and air quality in your facilities? Contact us today for more information!

GMP particle limits for hospital pharmacy.

Details

  • 43018 Sissa Trecasali, Province of Parma, Italy
  • Normeditec