m03[1]Sanitation and Hygiene

8/18/2019 m03[1]Sanitation and Hygiene

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Module 3 Slide 1 of 26WHO - EDM

Sanitation and

Hygiene

Basic Principles of GMP




Sanitation and Hygiene

Objectives

Review measures to ensure good sanitation in:

premises

equipment

processes

To review measures to ensure good personnelhygiene

Group session - to discuss the situation in yourcountry and to look at some bad sanitation andhygiene practices in some photographs.




Part One 4


Scope

All aspects of manufacturing

Personnel

Premises !uipment

Apparatus

Production materials and container

Products for cleaning and disinfection

All potential sources of cross-contamination




http://slidepdf.com/reader/full/m031sanitation-and-hygiene 5/26Module 3 Slide 5 of 26WHO - EDM

Part Two 15.1 – 15.34


Avoidance of Cross-Contamination I

%egregated areas

&entilation systems and airlocks

'lothing

'losed processing systems

'leaning and decontamination



Part Two 15.1 – 15.34


Avoidance of Cross-Contamination II

%egregated areas and separate facilities for

lie accines and other "iological materials penicillin products

campaign processing





Part Two 15.1 – 15.34


Avoidance of Cross-Contamination IV

'lothing

protection of operator and product

highly potent products or those of particular ris% )need for special protectie clothing

personnel should not moe "et!een areas

producing di$erent products

garments need to "e cleaned



Part Two 15.1 – 15.34


Avoidance of Cross-Contamination -V

'losed processing systems

*or example+ totally enclosed !ater puri#cationsystems

tan%s #tted !ith appropriate #ltration ) !ithout

remoa"le lids

present special cleaning diculties, sometimes

use

clean)in)place -C.P/



Part Two 15.1 – 15.34


Avoidance of Cross-Contamination VI

'leaning and decontamination

procedure for remoing soil and dirt remoe all cleaning chemical residues or disinfectant

residues

must remoe or reduce micro)organisms


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WHO - EDM


Production Operations – Sanitation – I

(ork-)ow

designed to aoid potential contamination0

Access

to production areas restricted to authori1ed

personnel

direct operators, 2C sta$, !arehouse sta$,

maintenance personnel, cleaners

the more critical the area ) fe!er num"er of

persons there



WHO - EDM


Production Operations – Sanitation – II

%imultaneous operations

not permissible to process di#erent products in di#erent

areas with a common ventilation system

permissible to carry out secondary packaging activities

for di#erent products within a packing hall with

ade!uate physical separation



WHO - EDM


Production Operations – Sanitation – III

Area clearance checks

Process of checking

all materials and documentation from the preious"atch remoed

all plant and equipment thoroughly cleaned and

appropriate status la"elling

chec%list useful





Production Operations – Sanitation – IV

Area clearance checks

The area clearance check should be carried out bytwo people

"et!een "atches of same product, accepta"le for

"oth chec%s to "e carried out "y production

personnel

for product changeoer, second chec% carried out "y

2C sta$

all chec%s carried out in accordance !ith !ritten S3Pand results recorded on the "atch documentation0





Production Operations – Sanitation – V 'leaning and cleaning validation

degree of cleaning depends on !hether consecutie

"atches are of same or di$erent product

'heck cleaning agent is fully removed *f possible hot water alone used for cleaning

all cleaning and disinfecting solutions carefully

prepared and expiry dated

+inal rinse with puri,ed water$ or water for inection

for sterile products/ +ull records kept





Production Operations – Sanitation – VI

(ater systems

(ater - maor constituent of most products

%0P for cleaning and sanitisation of the waterpuri,cation system should include distributionpipework

&alidation and removal of disinfectant before reuse





Production Operations – Sanitation – VII

1aintenance and repair

actiities ineita"le in manufacturing area0

Should present no ris% to product

(henever possible$ all planned maintenanceoutside normal operating hours

mergency work in working area followed bythorough clean down and disinfection before

manufacturing recommences Area clearance by 2'




Part One 10.16 – 10.23


Personne Hygiene – I

3ealth e4aminations

3n recruitment for direct operators , repeated on

regular "asis

Training - check

induction training for ne! operators includes "asic

personal hygiene training

!ritten procedures ) to !ash hands "efore entering

a manufacturing area

signs in changing rooms to reinforce hand !ashing




Part One 10.16 – 10.23


Personne Hygiene – II

*llness

sta$ !ith illness or open lesions should not handle

starting materials, intermediates or #nished products

Adverse conditions

operators trained to recogni1e ris%s

!illingness to report illness to the area superisor





Personne Hygiene – III

'ontact between product and operator

aoid direct contact

if direct handling unaoida"le, gloes should "e !orn

chec% gloe disinfection -for sterile production/ anddisposal

Part One 10.20 – 10.23, 11.7 – 11.8





Personne Hygiene – IV

'lothing and changing facilities

chec% changing rooms -hand!ashing, to!els or hot

air hand dryers/

chec% if used clothing stored in separate closedcontainers !hile a!aiting cleaning

laundering of clean area clothing must "e to S3P and

in appropriate facility

chec% for procedure for sterili1ing and storing

clothing for use in sterile area

Part One 10.20 – 10.23, 11.7 – 11.8





Personne Hygiene – V

%moking$ eating and drinking should not be allowedin any manufacturing area$ including laboratories andstorage rooms.

'hewing of gum should be banned. There should be no plants kept inside any factory

areas.

Rest and refreshment areas should be separate frommanufacturing areas.

Toilets should not open directly into production orstorage areas. Part One 10.20 – 10.23, 11.7 – 11.8





!roup Session - Option "

5ook at the photographs in the handout andrecord

as many sanitation and hygiene issues as youcan





!roup Session - Option #

6ou are inspecting a new factory. (hat are the key

issues for sanitation and the key issues for

personnel hygiene that the company should havein place7





Possible Issues – I

Sanitation

1i4ed production

Penicillins

Product versus batch changeovers

(ater systems

3ow long should a 8cleaned9 status last for7

(hat should happen if a clearance check is re!uired

when no 2' personnel are on duty7

Procedures and records





Possible Issues – II

Hygiene

Personal hygiene

3ealth checks

"ealing with health problems

Personal responsibility

Training records

+re!uency of handwashing

m03[1]Sanitation and Hygiene

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