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MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS. Module 4. Presented by : Deryck Smith Consulting Engineers. GMP Manufacturing Environments. Air Handling Systems HVAC Systems H eating V entilation A ir C onditioning Module 4: Pressure Cascades &

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mcc presentation gmp manufacturing environments

MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS

Module 4

Presented by :

Deryck Smith Consulting Engineers

gmp manufacturing environments
GMP Manufacturing Environments

Air Handling Systems

HVAC Systems

Heating

Ventilation

Air Conditioning

Module 4: Pressure Cascades &

Building Layouts

gmp manufacturing environments3
GMP Manufacturing Environments

Topics for this Module:

The integration of air conditioning systems and building layouts.

The requirements for pressure cascades and how to achieve them.

How building finishes and plant components affect facility cleanliness.

Pharmaceutical Equipment

inter dependence of air handling systems buildings
Inter-dependence of Air Handling Systems & Buildings
  • Building layouts, Pressure cascades, Air handling systems and Pharmaceutical equipment are all inter-related.
  • No one can exist without the other.
what is a pressure cascade
What is a Pressure Cascade?

Pressure Cascade

A process whereby air flows from the cleanest area, which is maintained at the highest pressure to a less clean area at a lower pressure.

what is the purpose of a pressure cascade
What Is the Purpose of a Pressure Cascade?
  • Helps prevent cross-contamination between adjacent areas.
  • Helps prevent ingress of contaminants from outside.
  • Is used to enhance separation between areas of different cleanliness.

The unit of measurement for pressure is the PASCAL (Pa)

measuring the air pressure cascade
Measuring the Air Pressure Cascade

The pressure differential over the doorway is measured with a portable magnahelic gauge or micro manometer.

Permanently installed gauges are preferred.

room pressure air movement
Room Pressure & Air Movement
  • A room pressure cascade system forces air to flow from clean areas to less-clean areas.
  • Air movement, such as laminar flow (UDAF) over

the product, protects the product. (aseptic packing / filling)

  • Directional air movement helps carry

contaminants away from a critical process. 

typical osd plant cross contamination protection
Typical OSD Plant : Cross-contamination Protection

What should the room pressures be ?

dispensary layout
Dispensary Layout

Is this a good layout ?

PIC/S PH 1/97 (Rev.3) #3.3 & 3.12

improved dispensary layout
Improved Dispensary Layout

Airflow direction

What should the room pressures be ?

sampling booth layout 1
Sampling Booth Layout (1)

EXTRACT

HOOD

SAMPLING

BOOTH

WAREHOUSE

poor design extract system
Poor Design Extract System

Section Through Sampling Booth

sampling booth layout 2
Sampling Booth Layout (2)

UDAF

HOOD

SAMPLING

BOOTH

AIR

LOCK

AIR

LOCK

CHANGE

Step-over-bench

what to qualify in the sampling booth suite
What to Qualify in the Sampling Booth Suite
  • Cleanroom class – ISO 8
  • HEPA filter integrity test
  • Airflow rates
  • UDAF velocity
  • Room pressures
  • Containment – smoke tests
  • Temperatures (< 25°C)
ablution layout 1
Ablution Layout 1

Production

Plant

Toilets

Staff

Change Room

Staff

ablution layout 2
Ablution Layout 2

Production

Plant

Change Room

Toilets

Staff

Staff

protective garments outside
Protective Garments Outside ??

It is pointless having

a change room if it

is not used properly

slide22

STERILE

CHANGE

5T

A/L

COMPONENT

5T

PREP

6

STERILE

STERILE

7

STAGING

FILLING RM

6

5U

6

AUTO-

CLAVES

FILLING

MACHINE

FORMULATION

ROOM

5T

CHANGE

A/L

AUTO-

7

CLAVES

6/7

8

7

PERSONEL

MAT.

MAT.

9

A/L

A/L

A/L

FINISHED PRODUCT STAGING

8

= Room Pressure

15Pa

= ISO Cleanroom Class

8

T = Turbulent

U = Uni-directional

Sterile Suite Pressure Cascade

product flow diagram
Product Flow Diagram

Wood free zone

RAW MAT.

RECEIPT

PACK. MAT.

RECEIPT

DISPENSARY

PACK. MAT

STORE

MANUFACTURING

PRIMARY PACK

MAT. CLEAN DOWN

PRIMARY

PACKING

GMP ZONE

SECONDARY

PACKING

DISPATCH

staff flow diagram
Staff flow Diagram

STAFF ENTRY

CANTEEN

RAW MAT.

RECEIPT

PACK. MAT.

RECEIPT

DISPENSARY

CHANGE

PACK. MAT

STORE

GMP

CHANGE

PRODUCTION

PRIMARY PACK

MAT. CLEAN DOWN

PRIMARY

PACKING

GMP ZONE

SECONDARY

PACKING

DISPATCH

negative pressure facilities
Negative Pressure Facilities
  • Required for facilities handling potent compounds such as penicillin & hormones.
  • Special precautions required to prevent product contamination from the atmosphere.
  • Exhaust air must be efficiently filtered and safe filter handling must be used.
safe change filters
Safe Change Filters
  • Used for filtering hazardous materials:
  • Dirty filters are removed into a plastic bag
  • The bag is automatically sealed at the filter unit housing
  • A new filter is inserted via a plastic bag and the cover closed
  • At no time is the operator or the atmosphere exposed to the hazardous powder.
case study penicillin plant
Case Study – Penicillin Plant

MALE

ABLUT.

Add room pressures,

Cleanroom class and

comment on layout

LAUNDRY

FINISH.

GOODS

case study penicillin plant28

WASH

TABLET

-30Pa

UP

SYRUPS

COMPRES-

CAPSULE

PREPARATION

SION

-40Pa

FILLING

-35Pa

MIXING

-35Pa

STAGING

DRY

-30Pa

GRANULATING

SYRUPS

POWDER

FILLING

-25Pa

-25Pa

-30Pa

FILLING

WEIGH

ROOM

-40Pa

PRODUCTION PASSAGE

-15Pa

-20Pa

PRODUCT

-25Pa

-30Pa

STORE

A/L

-45Pa

ABLUTIONS

-25Pa

PACKING

PACKING

-25Pa

-45Pa

MALE

GOODS

FEMALE

MAT

ABLUTIONS

A/L

-10Pa

-35Pa

SUPER-

-35Pa

VISOR

MALE

FEMALE

CHANGE

CHANGE

-35Pa

LEGEND

-35Pa

-35Pa

ROOM PRESSURE RELATIVE

-15Pa

TO AMBIENT

FINISHED

-35Pa

GOODS

AIR

LOCK

AIR LEAKAGE DIRECTION

-15Pa

-25Pa

Case Study – Penicillin Plant
building finishes
Building Finishes:
  • In module 1 we discussed the need for all facility components to complement each other.
  • Therefore a good air handling system must be complemented by a building of good design and good finishes.
  • On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes.
floors drains
Floors / drains

Tiled Floor

Epoxy Floor

poor good windows
Poor & Good Windows

Bacteria City !!!

paint finish
Paint Finish…
  • Not only building paintwork must be considered but also equipment

Is there anything wrong with this Tablet Press?

services distribution
Services Distribution

Impossible to clean!

Easy to clean!

keep a balance
Keep a Balance

Don’t ignore building finishes…

… and then go

overboard on

staff dress code.

services distribution37
Services Distribution
  • Where ever possible services should be located behind wall panels
  • Exposed services & pipes are very difficult to clean & sometimes impossible to clean
  • Equipment such as Film Coaters should be enclosed so that only the front face is in the GMP area. This makes cleaning much easier.
  • Make use of service corridors behind equipment (but must be under negative pressure)
split unit

RETURN AIR

SUPPLY AIR

Split Unit

Poor quality

Air filter

Cooling Coil

Condensate drip tray

Fan liberates dust

into the air

fluid bed drier
Fluid Bed Drier
  • Is the quality of the
  • supply air to the FBD
  • correct?
  • What filtration is used?
  • Is the exhaust air filtered?
modified layout with cascade
Modified Layout with Cascade

MAL = Material Air Lock

PAL = Personnel Air Lock

product flow diagram42

Work session: Connect the arrows between processes for Product Flow and Staff Flow

Product Flow Diagram

Raw Mat.

Store

Quarantine

Released

Materials

Primary

Change room

Sampling A/L

Sampling A/L

GMP Change

Room

Sampling

Booth

Pack Mat.

Store

Dispensary

Pre-Staging

Dispensary

Post-Staging

Dispensary

Weiigh Booth

Primary Pack

Mat. Clean Down

Pharmaceutical

Manufacturing

Secondary

Packing

Primary

Packing

F/G

Dispatch

product flow diagram43

Work session: Connect the arrows between processes for Product Flow and Staff Flow

Product Flow Diagram

Raw Mat.

Store

Quarantine

Released

Materials

Primary

Change room

Sampling A/L

Sampling A/L

GMP Change

Room

Sampling

Booth

Pack Mat.

Store

Dispensary

Pre-Staging

Dispensary

Post-Staging

Dispensary

Weiigh Booth

Primary Pack

Mat. Clean Down

Pharmaceutical

Manufacturing

Secondary

Packing

Primary

Packing

F/G

Dispatch