Equipment

1.1.1.2.1 Dedicated and Nondedicated Equipment

In pharmaceutical industries, dedicated equipment is used for the production of only a single product. This practice markedly reduces the chances of cross-contamination. Where the same equipment is used for the production of a range of products, the prevention of cross-contamination between products becomes the main challenge in the cleaning validation effort. Dedicated equipment should be clearly identified so as to prevent potential errors during cleaning and preparation. Nevertheless, cleaning nondedicated equipment represents a clearer impediment to overcome.

The cleaning of dedicated and nondedicated equipment also gives rise to concerns. CIP systems are often used for more than one tank in a facility. Special care needs to be taken in designing CIP systems. By using appropriate valving and backflow prevention, cross-contamination can be prevented. Similarly, any circulation within the CIP system should be constructed carefully and monitored closely during routine cleaning.

1.1.1.2.2 Minor and Major Equipment

Although there is no such terminology as minor equipment used in current good manufacturing practices (CGMPs), items such as utensils may be regarded as minor equipment. Major equipment represents those that play a central role in production processes. Typically, the cleaning of major equipment will be the subject of specific standard operating procedures (SOPs) and it is important to differentiate those pieces of equipment that are central to the production process from those that perform a secondary role (utensils). Material of construction should be of significant importance when establishing a cleaning validation program. CGMPs 211.65 emphasizes the material of construction as well as any substance required for operation, in which contact components, in-process materials, or drug products shall not be reactive so as to alter the safety and efficacy of the product beyond established requirements.

Equipment should not demonstrate any type of reaction with process materials, which contact them. Equipment with porous surfaces, for example, filters, filter bags, fluid bed dryer bags, membrane filters, and so on, will require thorough assessment while reviewing cleaning validation evaluations so as to ensure adequate product removal and minimize the potential for cross-contamination.

1.1.1.2.3 Noncritical and Critical Site of Equipment

Locations that have a tendency to endanger a single dose with a high level of contamination are called critical sites. Such locations or sites demand special cleaning emphasis. Besides ensuring that enough details are included in the cleaning procedure, the risk can be further reduced or completely eliminated by using more intensive sampling and testing plans. A more stringent acceptance criterion must also be established in this case to ensure effective cleaning validation.

1.1.1.2.4 Nonproduct Contact versus Product Contact Surfaces

As a matter of course, cleaning validation mainly focuses on product contact surfaces. However, in order to be more effective, programs for the elimination of cross-contamination must also address nonproduct contact surfaces. When establishing the prerequisites for nonproduct contact surfaces, the probable interactions of that area with the process must also be reviewed. This is important in order to make the cleaning program more effective.

1.1.1.2.5 Equipment Train: Simple and Complex

The group or collection of equipment or systems jointly functioning to carry out the production processes for a product is generally called "equipment train." There is a direct relationship between the complexity of cleaning validation and the complexity of the equipment train. The greater the pieces of equipment in the train, or the transfers of material involved in the process, the higher the complexity of cleaning validation.

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