Charity

Production managers in the medical device industry have long faced the need to determine the appropriate production environment for a given product. It is essential to decide whether a product or process calls for a clean manufacturing environment in which airborne particulates, temperature, humidity, airflow patterns, and other factors are controlled. Beyond that, production managers must also determine whether a clean workstation is sufficient or whether a cleanroom should be constructed.

Contamination control is vital for maintaining cleanroom environments. Pharmaceutical and semiconductor companies require especially stringent maintenance and sanitation programs to meet demanding standards for air quality, room design, and operation, such as those set by the International Organization for Standardization (ISO). ISO 14644-1, which defines guidelines for the classification of air cleanliness determined by the permissible particle size and levels of concentration, forces manufacturing facilities to maintain high standards for a contaminant-free facility to protect their equipment, products, and employees. Operational costs, long-standing cleaning procedures, and lack of proper equipment can stymie a company’s efforts to build a comprehensive maintenance program.

Yes. Most basic protocol programs for cleanrooms are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes in the cleanroom from the people working in the cleanroom. Whereas contamination may be due to the product, processes, or equipment in the clean-room, the people working in the cleanroom exercise the greatest control over the cause of and elimination of contamination. Therefore, all protocol programs address the functionality of the cleanroom, the behavior of the people working in the cleanroom,and the cleaning and maintenance of the cleanroom.

To ensure reliable and efficient day to day running of your facility, scheduled clean room maintenance is essential. We offers a complete and comprehensive maintenance and repair service for all aspects of your clean room including the ventilation system, fixtures and fittings and constructional fabric such as floors, ceilings and furniture.

Every cleanroom requires a carefully controlled environment maintained with Good Manufacturing Practices to prevent contamination. In 2012, a fungal meningitis outbreak in the United States was traced to a compounding pharmacy in the Northeast. The pharmacy distributed contaminated vials to medical facilities in 23 states. These were administered to more than 14,000 patients before anyone linked symptoms to the tainted medication.