PROCEDURE FOR ENTRY OF MAJOR EQUIPMENT INTO STREILE AREA

ST — 088
PROCEDURE FOR ENTRY OF MAJOR EQUIPMENT INTO STREILE AREA


By and large the major pieces of equipment into the sterile area such as large trolleys, ampoule filling sealing machine etc. by the very nature of the size will be moved into the sterile area either through the equipment entry door or through the change room.

Prior to moving such equipment into the sterile area, the production supervisor concerned and engineering department will ensure that it is in proper working condition. Additionally, it will be necessary to confirm that it is clean.

Just prior to the entry, the external portion of the machine will be sanitized with Sterile70% Isopropyl Alcohol and Sterile 2% Bacillocid solution (disinfectant). Initially, such a sanitized machine will be moved to the second cubical change room and retained there overnight under the UV lamp. On the following day, the machines external portion will once again be sanitized with Sterile 70% IPA and Sterile 2% Bacilloicd and then moved into the sterile area.

Should it be necessary, after the entry of the equipment, Fumigation may be carried out in the sterile room to ensure there has been no abnormal increase in Microbial Count due to the major piece of equipment.

Swab test should be taken of the equipment to confirm the proper disinfection.