Different Sources of Contamination in an Aseptic Area and Methods of Prevention

Different Sources of Contamination in an Aseptic Area

In an aseptic space, there are several contamination sources, which are addressed below:

Personnel -

• Training inadequately
• When there is direct contact between the bulk products, starting materials, packaging materials as well as the starting materials.
• Poor hygiene
• Personal entering the product control areas, production areas, as well as storage areas without authority.
• Insufficient protecting and growth of equipment
• Smoking, drinking and eating in processing and storage area.

Building and facilities - Microbial contamination is also significantly affected by the following factors:

• Inadequate space size and arrangement, leading to selection errors.
• Pest controls and poor filths
• When there is no presence of air filtration
• Improper personal cleanliness, improper washing, locker facilities, cleaning, sanitary operation, and toilet.
• Rough ceiling, walls, and floors.
• Poorly located ledges, vents, and drains

Equipment and utensils – while packaging, transferring and holding equipment and utensils are used. Most probably, for microbial contamination, they are the common sources and the reasons include -

• Inadequate sanitization and cleaning
• Unsuitable size, static material accumulation, unsuitable design, adulteration of lubricants, corrosion causing materials, coolants, sanitizing agents, dirt.
• Irregular service and inappropriate calibration
• Use of defective equipment
• Inefficient maintenance and cleaning due to their design.

Raw materials – raw materials are potential sources of microbial contamination and they are used during production. The contamination can occur due to the following reasons -

• Chemical and microbial contamination
• Making use of materials that do not even fulfil the approval criterion
• Due to extreme environmental conditions, degradation of raw materials
• Incorrect testing and sampling
• Improper handling and storage that eventually leads to selection errors and mix-ups.
• Wrong labelling

Manufacturing process - It is common for raw materials, intermediates, or packaging materials to become contaminated with microorganisms during the production process.

• The production of a single product is insufficient
• Inadequate cleaning between batches to reduce the number of product changeovers;
• Improper zoning,
• Failure to provide an area line clearance (according to established procedures) after each cleaning operation and between batches.
• Using an open production system enabled the product to be exposed to the environment in the room.
• Failure to label all equipment and materials used within the manufacturing facility with cleaning status.

HVAC (Heating, Ventilation, and Air Conditioning) System - An inefficient HVAC system may be a source of microbial development and disperse pollutants throughout the industrial unit. This happens for the following reasons:

• When there is inadequate air filtration system
• Accumulation of organic materials near or in HVAC air intakes
• When there is an incorrect ratio of re-circulated air to fresh air
• When the primary packaging area and production area has a non-directional flow
• Incapability of filtering the manufacturing areas from outside as well as accessing ventilation
• When the flow is reversal and the primary cause of it is an inadequate magnitude of pressure differentials.

Methods of Prevention of Contamination

To prevent microbiological contamination of objects in aseptic settings, the following methods are mentioned:

Personnel – these can take the following measures

• Unauthorized individuals should be barred from entering production zones, and only trained workers should be allowed in.
• Proper staff hygiene must be maintained.
• Personnel should get adequate and consistent hygiene training to guarantee that their operations do not impair product quality.
• When entering the production area, employees should wear protective equipment (over-garments, hair covers, beard or moustache covers, and overshoes).
• Personnel should avoid using their bare hands to handle exposed products or any element of the equipment in touch with the product.

Facility design – there are the following measures that are included in it -

• The differential air pressures in aseptic rooms should be higher than in neighboring controlled spaces.
• To achieve the desired clean room class, the air filtration and air change rates must be adjusted.
• To maintain unidirectional air flow (laminar flow) sufficiently fast so as to remove particles from the area during filling/closing.
• The humidity and the ambient temperature should be moderate.
• A ventilated cabinet, RABS (Restricted Access Barrier System), isolation system, etc. can lead to a complete or partial barrier for containing microorganisms at their site of use, depending on the results of the facility/product risk assessment.
• UV air locks and door barriers separate the areas of varying threat.
• All open-container processing must take place within the isolator/RABS.
• The changing room's air pressure should be negative in relation to the production area corridor, but positive in relation to the exterior surrounding regions.
• HVAC air distribution components should be employed to prevent pollutants from spreading throughout space.
• All surfaces and rooms should be maintained every two years and checked for viable and non-viable particles, as well as re-certified.

Although facility and equipment design cannot totally eradicate microbial contamination, competent risk assessment and subsequent hygienic design may significantly minimize these hazards. As an example,

• Effective cleaning can happen when there is equipment that has smooth surfaces of the right material.
• Closed material transfer systems
• Flow of material and man should be uniform

Access to areas –

• There should be specific routes (usually air locks) through which materials should be accessed
• Every person should get access to certain areas only through changing rooms.

Building requirements – these are the following measures -

• To facilitate effective and easy cleaning, easily cleanable walls, ceiling, floors should be used as well as being crack-free and smooth.
• To undergo easy cleaning, there should be a design that includes proper pipe work, light points, as well as ventilation.
• Within the production areas, the sinks of stainless sinks should be present and it's mandatory.
• It is always a good idea to keep the windows and viewing panels closed in order to prevent dust and microbes from accumulating. They should be sealed and fixed with walls.

Cleaning and disinfection – these are the measures that should be taken care of -

• Disinfection of certain areas and time-to-time cleanliness should be done.
• To minimize all the health risks, there should be the sue of proper grades of cleanliness agents
• Do not use the cleaning agents directly on the product.
• The process effectively controls microbial contamination and certain cleaning practices should be used to prove that.
• In every aspect of drug product manufacturing, there should be the use to adequate hygiene and it should be maintained too.
• While undergoing the cleaning process, the application, contact time, mechanical action, temperature as well as the chemistry of cleaning agents should be considered.

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