Sanitation AND HYGIENE

Created byAnisaWawan GunawanNuryantiSanitation ANDHYGIENE1High level of sanitation and hygiene should be practiced in every aspect of manufacturing medical product

The scope of sanitation and hygiene covers :PersonnelPremissesEquipment and containersProduct for cleaning and desinfectionAnithyng that could become a source of contamination to the product

INTRODUCTION

PERSONAL HYGIENE

every person should wear protective garment appropiatePREMISES SANITATION

Design and construction To facilitate good sanitation

Easily accessible to manufacturing areas

suitable facilities should be provided in appropiate locations for storage employees clothingEQUIPMENT CLEANING AND SANITATION

Equipment should be clenaed both inside and outside after use according to established procedure.Vacum and wet cleaning methods are to be preferredVALIDATION OF CLEANING AND SANITATION PROCEDURESWritten procedures should be established for cleaning of equipment and its subsequent release for use in the manufacture of medicinal product include intermediatesThese procedure include :Assigment of responsibility for cleaning equipmentCleaning schedule include sanitizingA complete description of the method an d materialsInstructions for dissasembling and reassembling each article of equipment to ensure proper cleaning instruction for the removal of obliteration of previous batch identificationInstruction for the protection of clean equipment from contamination prior to useInspection of equipment for cleanliness immediately before useEstablishing the maximum time that may elapse between the completion of prossesing and equipment cleaning