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Introductory Validation and the

Cleanroom

What we see
FDA regulations require Documentation
These regulations do not provide Guidelines
on how specifically to product the
documentation
It is left up to the specific companies to
design their own documentation system.
This includes the process of validation

Validation and Qualification


Validation contains premises from which a
conclusion can be logically derived

Qualification is a condition or circumstance


that must be met or complied with

Can anyone give examples of


validation?

Validation organization
As a department validation should cover

Process
Equipment
Facilities
Computer
Cleaning

Steps in developing Validation


are

Setup a validation dep.


Write a validation plan
Write policies, sops
and admin procedures
Establish change
control board
Establish document
reviewers and
approvers

Establish document
distribution
Identify equipment to
validate and make a
list
Assign protocols to all
functions
Validate most critical
equipment first

Assign equipment
numbers
Assign protocol numbers
Assign change control
numbers
Change protocols
Perform commissioning at
the original equipment
manufacturer

Write and execute


qualification protocols
Deficiencies
Deviations
Addendums
Archiving
Requalifiction
Internal audits
FDA audits

Qualification Testing
Written qualification protocols are prepared
that specify the tests to be conducted and
the data to be collected.
Observations are documented.

What needs to be tested?


Almost everything needs to be tested
How does one know?
Observe the equipment in operation
Major components are typical.

What level of testing is required


A standard for equipment testing has not
been made in the pharmaceutical industry
Object is to gain confidence that the
equipment is operating under a state of
control. Some include
Minimum/maximum operating ranges
Worst case

How much testing is Enough?


The number of repetitions of a process step
during qualification should be based on
statistical significance.
Conventional wisdom
Once is chance
Twice is nice
Three times is validation

Sorry but we need to use Statistics.

The Cleanroom
A room that is clean

ISO standard 14644-1


A room in which the concentration of
airborne particles is controlled, and which is
constructed and used in a manner to
minimize the introduction, generation, and
retention of particles inside the room and in
which other relevant parameters, e.g.
temperature, humidity, and pressure, are
controlled as necessary.

Who uses clean rooms

Electronics
Semiconductor
Optics
Biotechnology
Pharmacy
Medical Devices
Food and Drink

2 major types of cleanrooms


Turbulently ventilated room
(diffuses)
20 changes per hr min

Unidirectional flow
Air sweeps across the room (80ft/min)

Both have clean air on top, moving to the


bottom.

Particles

Human Hair (100um)


Visible particle (50um)
E. coli (A bacteria) 1um
Particles we typically measure 0.5um

Some Numbers of ISO classes


limits (particles/m3 of air)

Class 1
Class 2
Class 3
Class 4
Class 5

10
100
1000
10,000
100,000

Also limits on microbe contam


Grade

Air sample

Settle plates

<1

<1

10

100

50

200

50

Some Cleanroom Disciplines


A walking person generates 1,000,000
particles permin (0.5um)
Some conditions will preclude work in a
cleanroom

Skin conditions (dermatitis)


Respiratory conditions
Microfloura
Allergies

Other Conditions

Good personal hygiene


Cosmetics
Jewelery
Smokers particles and out gassing

Control of air transfer

Enter and exit through change areas


Do not leave doors open
Open and close doors quickly
Doors usually open inward in production
facilities
Respect the airlocks

Behavior

Sitting 100k, moving 1milK, walking 5milk


Positioning so do not drip on product
Use no touch techniques
Do not support materials on body
Do not talk over product

Entry and Exit of Personnel

Hygiene
Cloths, makeup and jewlery
Wash before and after
Check yourself and check others

Are you protecting product or yourself.

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