Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas

Aseptic area is used to manufacture sterile products in pharmaceuticals. The aseptic area is maintained by following strict cleaning and disinfection procedures. Maintenance of aseptic conditions in the sterile area can be challenging. Various aspects of aseptic area maintenance are discussed in this article.

What are Aseptic Facilities?

Aseptic facilities maintain sterile conditions to prevent sterile products from contamination. Sterile facilities are required to meet the requirements and recommendations of regulatory authorities like the FDA, EMA etc. The sterile area in manufacturing facilities includes a processing area, storage area and laboratory.

It is critical to maintain sterile conditions, some strict procedures and policies must be followed strictly in all situations. All employees must be trained to follow the sterile area rules and regulations. All employees must know the do's and don’ts of the sterile area. All equipment used in the sterile area must be sterilized by a validated sterilization method. All these policies help to maintain the sterile area and produce a contamination-free product.

Why is it Important to Maintain a Sterile Area?

Sterile products must be prevented from contamination, so it is important to maintain sterile conditions properly to manufacture quality and safe products. If sterile conditions are not maintained properly then the product may have contamination and it will not safe for the patients. Proper maintenance of the sterile area will also ensure the health of the employees those are working in the area and the safety of the patients.

How to Maintain the Aseptic Area?

Cleaning and sanitization are the main parts of aseptic area maintenance. All equipment and surfaces must be cleaned and free from any potential contamination. There are many ways to maintain the aseptic area. Some of those are listed here.

1. Proper Gowning: Personnel entering the sterile area must strictly follow the sterile gowning procedure it includes a sterile gown, gloves, and hood. It should be followed by personnel as well as visitors.

2. Regular Cleaning: Sterile area must be cleaned regularly according to the well-defined procedure to control contamination. The cleaning must be done by the validated cleaning agent/ disinfectant and those must be rotated periodically to avoid the potential resistance in microbes.

3. Air Quality Control: Air is the most important part of the sterile manufacturing area. HEPA filters are used to filter the contaminants from the air entering the sterile area. Low temperature and positive pressure can also help to minimize the risk of contamination.

4. Control of Traffic: Traffic denotes the personnel movement in the area. There should be minimum personnel movement in the area to control the contamination. Limited entry demarcation should be there to control the traffic.

5. Equipment and Material Sterilization: The equipment and material used in the sterile area should be sterilized before use and unsterilized material should not be entered into the sterile area. Unsterilized material is the source of potential contamination in sterile area.

6. Proper Waste Disposal: Waste in the sterile area is another big source of contamination. Waste should be disposed of properly by approved methods to prevent contamination.

How to Ensure the Sterility of the Area?

There are many ways to ensure that the sterile area is maintained properly. One of the most common ways is to train the employees to follow the sterile area rules and regulations strictly. Implement the system, so that the staff can easily find the source of contamination. Another way is to monitor the sterile area and equipment microbiologically for potential contamination. The area must be monitored by active and passive air sampling in every working shift and equipment surface and personnel working in the area must be monitored using swabs and contact plates so that you can find the problem before it becomes serious.

Cross-contamination is a major problem in the sterile area. Cross contamination may occur if any staff member enters the area without proper gowning or any other protective gear. Improper cleaning or sanitization of equipment can cause microbial growth and the spread of microbial contamination in the area. Any contamination in the area can compromise the sterility of the product. Improper handling and storage of the intermediate and final product can also contaminate the product.