A company recently received this 483 observation:
…. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
a. We observed gloves purported to be sterile stored in the gowning room, in plastic boxes, without individual wrappers. These gloves are sterilized in bulk at the firm. We observed multiple employees open the box, take out and wear the unwrapped gloves and enter into the aseptic area. The gowning room is classified as class 10,000 area.
b. We observed during the manufacture of … (lot #…) in cleanroom …. that all three operators had exposed skin such as forehead, nose and side of the face, as their hood and the goggles did not cover their faces fully, in addition, they were all observed to be wearing … while the SOP …, “Gowning Procedure for the Cleanroom” requires wearing … prior to entry into the cleanrooms.
c. We observed used gloves, gown and hood placed on the stainless-steel gowning table, where sterile gowns are placed prior to gowning.
For more observations pertaining to Sterile Manufacturing controls, see Issue 1046 available today. It also has observations pertaining to lab controls, manufacturing controls, and medical devices.