SANITATION

AND
HYGIENE

Created by
Anisa
Wawan Gunawan
Nuryanti

INTRODUCTION

High level of sanitation and hygiene should be practiced

in every aspect of manufacturing medical product
The scope of sanitation and hygiene covers :
Personnel
Premisses
Equipment and containers
Product for cleaning and desinfection
Anithyng that could become a source of contamination
to the product

PERSONAL HYGIENE
every person should wear protective garment appropiate

personal hygiene procedure should apply to all persons

Soiled uniforms and soiled cleaning cloths shlud be stored in separate closed
All personel should receive medical examination,practices good personal
hygiene, report if there is an open lesions or illness

PREMISES SANITATION
Design and construction
To facilitate
good sanitation

Easily accessible
to manufacturing areas

suitable facilities should be provided in appropiate locations

for storage employees clothing

Adequate facilities for clothes storage, all of which relate with food and beverages should be restricted only
specific areas.
Waste material should not be allowed to accumulate; rodenticides, insectisides, fumigating agent and
sanitizing materials shouldt be premitted to contaminated equipment and materials in room production and
there are written procedures for it.
Sanitation procedures should apply to all of employees and contractors and there should be written
procedures assigning responsibility for saitation

EQUIPMENT 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 preferred

Cleaning and storing of mobile equipment should be done in room separated from processing areas

Written procedure in sufficient detail should be established,validated and followed for cleaning and
sanitizing equipment and containers used in the manufacture of medicinal products.

Record pf cleaning, sanitizing, sterilization and inspection prior the use should be kept properly

Desinfectans and detergent should be monitored for microbiological contamination and should be
kept in previously cleaned

VALIDATION OF CLEANING AND SANITATION PROCEDURES

Written procedures should
be established
for cleaning
of equipment
and its subsequent release
These
procedure
include
:
for use in the manufacture of medicinal product include intermediates

Assigment
of
responsibility
for
cleaning equipment
Cleaning schedule include sanitizing
A complete description of the method
an d materials
Instructions for dissasembling and
reassembling
each
article
of
equipment to ensure proper cleaning
instruction for the removal of
obliteration
of
previous
batch
identification
Instruction for the protection of clean
equipment from contamination prior to
use
Inspection
of
equipment
for
cleanliness immediately before use
Establishing the maximum time that
may elapse between the completion of
prossesing and equipment cleaning

The cleaning sanitation and hygiene procedures

should be validated and evaluated periodically
There should be written procedures and the
associated record of action