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.