EQUIPMENT

DESIGN  I  CLEANING I MAINTENANCE

DESIGN

Equipment design, size and location should be appropriate to facilitate:

• intended use
• Cleaning
• Maintenance

Equipment Construction

• Surfaces coming in contact with components, inprocess materials or Drug Product must be not be reactive, additive or absorptive
• Materials required for operations like lubricants coolants etc must not come in contact with components, inprocess materials or drug products to prevent contamination.

CLEANING

Cleaning, Sanitation and or Sterilization

Cleaning Validation and written procedures

Maintenance and cleaning schedules,

A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations

Removal or obliteration of previous batch identification;

Inspection/line clearance of equipment for cleanliness immediately before use.

Cleaning, sanitizing, and inspectionrecords

AUTOMATION  I FILTRATION

• Regular Inspection
• Calibration
• Written records

FILTRATION

Filters for liquid filtration shall not release fibers into such products.

Fiber-releasing filters may be used when it is not possible to manufacture such products without the use of these filters. In such cases additional nonfiber-releasing filter having a maximum nominal pore size rating of 0.2 micron (0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug product. 

Frequency of filter change must be defines and recorded