Hygiene Master Plan

Question 1

what is the main aim of the hygiene master plan

Answer 1

protection of product, prevention from contamination of the product

Question 2

Sources of contamination?

Answer 2

particulate, biological and chemical

Question 3

Aims of HMP?

Answer 3

• Product quality (related to contamination)
• Health prevention of employees [when working with microorganisms or highly potent drugs] (and patients)
• Proper use and handling of cleaning agents and disinfectants

Question 4

By general principles

Answer 4

• Definition of the material and personnel flow
• Definition of processes
• Premises and installations

Question 5

Responsibilities

Answer 5

•
Head of manufacturing
•
Head of quality control (for laboratories)

Question 6

personnel hygiene, source of contamination?

Answer 6

Clothing, hygiene behaviour, process behaviour and health status

Question 7

clothing concept?

Answer 7

the higher the requirements on the product, the higher the requirements on clothing

Question 8

clothing concept?

Answer 8

Directly correlated with zone division
It has to be defined, if clothes have to be changed when entering a new zone
For each zone questions regarding the related clothing rule have to be answered:

Question 9

Clothing –technical aspects to be considered

Answer 9

Particle emission, Filtration quality, Wear properties,Electrostatic behaviour,Stability,Costs

Question 10

Testing particle emission of clothing?

Answer 10

ASTM-F51-68 Method (Standard Test Method for Sizing and Counting Particulate Contaminant in and on Clean Room Garments)

HelmkeDrum Test (Garment System Considerations for Cleanrooms and Other Controlled Environments)

Question 11

Hygienic hand disinfection defined where?

Answer 11

EN 1500

Chemical disinfectants and antiseptics –Hygienic handrub–Test method and requirements

Question 12

what is importance in developing a hygiene training?

Answer 12

RA and time and content of the hygiene training

Question 13

Sourcesof contamination in production

Answer 13

Raw materials,
pharmaceutical gases
ambient air
aids
packaging material
processess
personnel
surfaces

Question 14

Clean zone concept as preventive measure (EU-GMP-Guideline Part I chapter 3,)

Answer 14

• minimizing the risk of contamination
• maximizing protection against the entry of insects or other animals
• prevent the entry of non-authorized people

Question 15

Clean zone concept as preventive measure (Physical barriers protect)

Answer 15

processes and products
•air pressure and air exchange rate
•lock systems for personnel
•lock systems for material

Question 16

Clean zone concept

Answer 16

A: environment for most critical processes (fillings of sterile products, aseptic production)

B: background environment for A

C and D: environment for less critical processes

Question 17

Pressure cascade

Answer 17

In operation:

ΔP betweensubsequent zones: 10-15 Pa

The cleaner the zone, the higherthe pressure*

Pressure is monitored in real time

At rest:
Pressureis reduced but cascade is kept

Question 18

the contaminat carrier in the clean zone concep is?

Answer 18

…human involvement is reduced

…the use of the equipment is reduced

…the use of air is regulated

…the use of water is regulated

Question 19

Disinfectants important to state?

Answer 19

“The effectiveness of
disinfectants and the
minimum contact time
on different surfaces
should be validated.”

Question 20

Factors influencing efficacy of disinfectants

Answer 20

•
Temperature of the solution
•
Effective concentration of the solution
•
pH value
•
Saturation and penetration into the cell membrane of microorganisms
•
Contact time
•
Contaminants

Question 21

General cleaning processes?

Answer 21

dry cleaning
cleaning
rinsing
drying

Question 22

Beside considering:

Answer 22

• Hygiene design when rooms are planned and built
• Cleaning of installations
• Cleaning concepts

Question 23

Mind the following aspects:

Answer 23

•
Condensation points in premisesand installations
•
Use dust collecting mats in locks
•
Check wall, floor, ceilings regularly
•
Check sealing between wall and floor etc.
•
Pest control

Question 24

Background of each hygiene plan?

Answer 24

identification of a risk
risk analysis and assessment
Risk control
documentation and evaluation

Question 25

Identification of a risk

Answer 25

• Contaminants from processes and cleaning
• Direct and indirect ways of contamination
• Physico-chemical properties

Question 26

Risk analysis and assessment

Answer 26

•
Effectiveness and reproducibility of a cleaning process
•
Hygienic plant design
•
Environmental influences

Question 27

Risk control

Answer 27

•
Controlling the cleaning process
•
Verifying the cleaning success
•
Environmental monitoring

Question 28

Room cleaning protocols should include information regarding

Answer 28

-
The room
-
If action is cleaning or disinfection
-
What object is addressed (wall? Floor? Ceiling,…)
-
Lot numbers of cleaning agent and / or disinfectant
-
Signature of the cleaning person
-
Signature of the controlling person

Question 29

Overall hygiene status should be checked by

Answer 29

•
Evaluating Monitoring results
•
the documentation of the premises
•
Regular sanitary inspections

Question 30

Adequate limits for warning levels

Answer 30

•
For sterile production see: EU GMP guidance I
•
For non-sterile products: levels of action have to be defined