| Equipment used in the manufacturing of drug products shall be of appropriate __, __ and suitably __ in order to assure product quality and process reproducibility and to facilitate its cleaning and maintenance. | 1 design and construction
2 adequate size
3 located |
| The design and construction of equipment shall fulfill the following
requirements: | 1 the equipment surfaces coming in contact with any material shall not be reactive, additive or absorptive so as to alter safety, strength, identity, quality or purity of
the drug beyond the established limits
2 equipment shall not adversely affect the product through leaking valves, lubricant drips, inappropriate repairs, maintenance, modifications or adaptations
3 materials required for specific operations, such as lubricants or coolants shall not come into contact with any in-process materials as to alter the strength, safety, identity, quality, or purity of raw material, intermediate, bulk or the finished product
4 equipment shall be easily and conveniently cleanable
5 all equipment designated for use with flammable substances or chemicals shall be explosion proof
6 equipment employed for weighing, measuring, testing and recording shall be regularly checked for accuracy and calibrated according to an appropriate program and procedure; records shall be maintained.
7 filters for liquid filtration used in the processing of products shall not release fibers or substances into such products. |
| Installation and Location | 1 Equipment shall be suitably installed and located to eliminate cross-contamination
2 Equipment shall be located at a sufficient distance from other equipment to avoid congestion and to ensure that products do not become admixed or confused with one another.
3 All open mechanical belts and pulleys shall be equipped with safety guards. Water, steam and pressure or vacuum lines shall be installed so as to be easily accessible during all phases of operation. These shall be adequately labeled and marked to be easily recognized.
4 Each piece of equipment shall be clearly marked with an identifying number.
5 All pipes, tanks, jackets for steam or coolant shall be properly insulated to prevent possible injury and to minimize energy loss.
6 Piping to equipment designated for use with the pressurized steam shall be properly trapped and drained.
7 Heating, ventilation, air conditioning, potable water, purified water, distilled water, clean steam, compressed air, gases and other support systems must undergo validation. |
