Pharmaceutical companies encounter a range of hurdles concerning air filters, impacting product quality and regulatory compliance:
Poor Filtration Efficiency: Ensuring filters effectively capture microscopic particles and contaminants is vital due to cheap quality products and unprofessional installation.
Regulatory Compliance: Meeting stringent Good Manufacturing Practices (GMP) standards demands precision.
Filter Integrity: Maintaining filters’ integrity during installation and use is a constant challenge due to lack of knowledge and dependency on Validation company, who sometimes do not perform the test only provide fake reports at regular intervals.
Timely Replacement: Ignoring to filter replacement schedules as per usage, Concentration levels on particular location is crucial to avoid efficiency degradation.
Documentation: Detailed records are essential for validation and regulatory adherence. Certifications of filter manufacturer and clean room validation company should be checked weather their instruments are calibrated or not and their certifications should be verified from certifying body for proper traceability.
Cost Management: Balancing quality filtration with budget constraints is a continuous concern, as filters with poor quality having high pressure drop increase electricity consumption load.
Pressure Drops: High-efficiency filters may lead to increased pressure drops, affecting HVAC performance and increase the energy consumption, which leads to high electricity bill.
Chemical Compatibility: Selecting filters compatible with pharmaceutical processes and chemicals is essential.
Contingency Plans: Preparedness for filter failures or clean room breaches is essential.
Disposal: Proper disposal of used filters, especially hazardous ones, requires careful consideration, if not done properly this will damage the environment.
Navigating these challenges is essential for pharmaceutical companies to ensure product quality and safety while complying with rigorous regulations.