birmingham chamber of commerce

7/24/2019 Birmingham Chamber of Commerce

1/29

Presentation by Steve Heyes

3rdOctober 2012

Cleanrooms & ContainmentFacilities: An Introduction


2/29

Business Profile

Delivery of operationally

critical facilities & systems

based on a design build or

design developed approachwithin key market sectors.

Pharmaceutical

BiotechnologyHealthcare

Nutraceuticals

Aerospace & Defence


3/29

A room or suite of rooms, purpose

designed and constructed, with fabric and

environmental control measures to limit the

propagation, introduction and maintenance ofairborne contamination

A room or suite of rooms,

purpose designed and constructed, with fabricand environmental measures to offer physical

and bio-security control

Definitions

Cleanroom:

Containment Room:


4/29

Containment Laboratories: Levels 14

ACDPAdvisory Committee on Dangerous

Pathogens

GMO (CU)Genetically Modified Organisms

SAPOSpecified Animal Pathogen Order

LPCBLoss Prevention

ATCSAAnti-Terrorism, Crime & Security

cGMP Guidelines (Orange Guide)

ISO Standard 14644 Pts 1 - 8

Cleanrooms: ISO 19 and Grade A - D

ISPE Baseline Guides

Classification Guidance


5/29


6/29

cGMP GuidelinesPharmaceutical

Biotech

Bio-sciences

Healthcare

Aerospace

Micro-electronics

Nanotechnology

Defence

Optics

Medical Device BS EN ISO Guidelines

Regulatory influenced

MHRA

FDA

VMD

NICE

HTA

HFEA

Sector Influence


7/29

Pharmaceutical - LyophilisationDefenceCore LoadMicro-electronicsWafer FabricationFood & DrinkSports Drinks

Sector Influence - Examples


8/29

Particle Size - Cleanroom Scale > 0.1m to > 5m

Pin head = 1500 m

Bacteria = 0.3 - 60 m

Red blood cells

= 40 - 300 mHuman hair

= 5 - 10 mCement dust = 3 - 100 m

Viruses = 0.0050.3 m

1m = 1 millionth of a metre 0.000001m

Particle Size Awareness


9/29

Federal Standard 209

BS 5295

ISO 14644 EU GMP

Classification Referencing


10/29

CL4

CL3

CL2

CL1

Lab standards derived

from pathogens handled

Biological agents that could cause human disease but unlikely to

spread + effective treatment available

Biological agents unlikely to cause human disease

Biological agents that can cause severe human disease with

risk of spreading + usually effective treatment available:

Biological agents that can cause severe human disease withrisk of spreading + usually no effective treatment available:

Ebola virus, congo haemorrhagic fever

TB, bacillus anthracis, yellow fever

Classification Referencing


11/29

Process ?

Regulatory

Impact

Architecture

Validation

M&E Building

Services

Starting Point


12/29

Facility Pressure Control (critical)

Particulate Control (critical)

Temperature Control (process or occupants?)

Humidity Control (process or occupants?)

Noise Control (process or occupants?)

Lighting Control (process or occupants?)

Environmental Performance


13/29

CleanroomCoreAirlockCorridor

Cleanroom

Preparation

15pa 25 - 30pa 40 - 45pa

Positive Pressure Control - Typical

0pa

Pressure Control - Cleanroom


14/29

CleanroomCoreAirlockCorridor

Cleanroom

Preparation

40 - 45pa 25 - 30pa 15pa

Negative Pressure ControlProcess Dictates

0pa

Pressure Control - Cleanroom


15/29

CL3 LabCoreAirlockCorridor

CL3 LabPrep

- 15pa - 30pa - 45pa

Negative Pressure ControlProcess Dictates

0pa

Pressure Control CL3


16/29

Room Contamination

Biggest space

contaminator - operators

Process shedding

Room clean-up rates

HVAC - Cleanrooms


17/29

ISO 98ISO 76 & Grades B, C, D

HVACOperational Principle


18/29

ISO 5ISO 4 - 1

HVAC - Operational Principle


19/29

High level air in

Low level air out

HLFU

Grade B background

UDAF return air

Vertical UDAF

Low level air return

High level air make-up

HVAC - Cleanrooms


20/29

Air change rates

ISO 98: Turbulent flow,

terminal HEPA filters not

required


terminal HEPA filters required

ISO 51: UDAF, terminal

HEPA filters required

HVAC - Cleanrooms


21/29

Air change ratesTypical Norms



required





515 per hour

20 - 50 per hour

Not calculated

HVAC - Cleanrooms


22/29

Supply Air Quality



required





F5 + F9

G4 + F7 + H14

F5 + F7 + H12 + H14/15

HVAC - Cleanrooms


23/29

Negative pressure

cascade critical

Air change rate not as

important as with

cleanrooms

Extract air must be HEPA

filtered

- 30 pa

10 - 20 per hour

Not calculated

HVACCL3


24/29

High air change rates promotes large void needs

Cleanroom - Service Interface


25/29

Bio-security risks promotes minimal service interface

CL3Service Interface


26/29

Commissioning: Testing, proving &

documentation of facility system/s to

demonstrate and satisfy the safe functionality

in accordance with the design criteria

Validation: Qualification practices, fully

documented, to provide the necessary

assurance, through pre-defined test/s toprove that the critical systems operate in

accordance with the facility design criteria

Commissioning & Validation


27/29

Through critical System

Impact Assessment only those

systems with direct affect on/to

the product will be qualifiedIn essence this is a roadmap

for the validation process,setting the criteria for

guidance, resource and

planning of the qualification

process

The URS defines the project

requirements without being

overly prescriptiveThe DQ checks the design

against the URS

The IQ checks the physicalinstallation against the

drawingsThe static system component

performance check

The static system component

performance check



28/29

Room differential pressures

Air change rate

UDAF air velocities ( 0.45m/s 20% )

Room clean-up rates

Filter integrity checks

Air patterns from smoke visualisation

Micro-biological challenge

Room particle counts

Validation OQ Activities

Air & water volumes

Control functionality

Lighting checks

Temperature & humidity checks

Noise level checks

System pressure testing

Air & water pressures

Commissioning



29/29

The facility should be air-tight

Switching off at night & running costs

Need to ramp the fans up when the doors open

All my HEPAs have failed

It wont hold pressureget the mastic gun!!

Issues & Misconceptions

birmingham chamber of commerce

Documents