ISOLATORS and EQUIPMENT INTEGRATION Loris Rinaldi Learning - - PDF document

▶
isolators and equipment integration
SMART_READER_LITE
LIVE PREVIEW

ISOLATORS and EQUIPMENT INTEGRATION Loris Rinaldi Learning - - PDF document

Nov 29, 2022 26 likes •183 views

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA ISOLATORS and EQUIPMENT INTEGRATION Loris Rinaldi Learning Objectives At the conclusion of this session, participants will be able to: Evaluate overall isolator

slide-1
SLIDE 1

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 1

ISOLATORS and EQUIPMENT INTEGRATION

Loris Rinaldi

2

Learning Objectives

  • At the conclusion of this session,

participants will be able to:

  • Evaluate overall isolator performance.
  • Recognize key aspects for equipment

integration into isolators.

  • Address containment and cleanability

requirements for isolators.

slide-2
SLIDE 2

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 2

3

Containment

  • Using an accurate pressure

control, the system must guarantee an internal pressure lower than the external pressure ∆p = 50 ÷ 250 pascals

  • In case of accident (leak,

glove leaks…) the system must be able to maintain an inward air flow, in order to avoid the exit of any toxic product (powder, liquid or gaseous)

  • The internal pressure must be

lower than the external pressure

4

Aseptic

  • Using an accurate pressure

control the system must guarantee an internal pressure higher than the external pressure ∆p = 50 ÷ 250 pascals

  • In case of accident (leak,

glove leaks…) the system must be able to maintain an

  • utward air flow, in order to

avoid any contamination of the internal environment by non aseptic air

  • The internal pressure must be

higher than the external pressure

slide-3
SLIDE 3

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 3

5

O2 and Moisture control

  • Some products are sensitive to

any contact with O2 and/or

  • moisture. In those cases the

system must be purged with Nitrogen or other inert gases and it must be equipped with sensors to evaluate the environment before that any activity starts.

  • With high sensitive products

the system must be equipped with a purification system in

  • rder to reach very low levels
  • f O2 and moisture (few ppm)

N

The internal environment must be O2 and Moisture free

6

Isolators for all types of applications

  • Three main aspects to consider:

1) Environmental control 2) Equipment integration 3) Cleanability

slide-4
SLIDE 4

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 4

7

1) Environmental Control

  • ISO 10648-2 leak tightness classes 1-4
  • OEL/OEB
  • Air Flows

8

ISO 10648-2 leak tightness classes 1-4

Any Isolator should pass the Leak Test class 2 ISO 10648-2 !!!

slide-5
SLIDE 5

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 5

9

OEL/OEB

OEL OEL Range Design 1 > 1000 µg/m3 General room ventilation. Conventional open equipment with local exhaust ventilation (LEV) 2 50 to 1000 µg/m3 Semi-closed to closed material transfers; laminar flow / top-down flow, engineered LEV. 3 20 to 50 µg/m3 Transfers using direct coupling & closed systems, selected use of unidirectional air flow booths. 4 1 to 20 µg/m3 Totally enclosed processes; transfers using direct coupling; barrier/isolator technology. 5 < 1 µg/m3 Isolator technology; remote operations, fully automated.

10

Unidirectional Air Flows

  • 0.45 m/s 20% air

speed (1.48 ft/s 20%)

  • Fastest “ambient

class” recovery time

  • Excellent with powder

(in that case a top- down flow must be adopted

  • The huge amount of

air to be handled must be taken into consideration

HEPA Filter Air inlet HEPA Filter Air outlet HEPA Filter Air inlet HEPA Filter Water Drain Side views

slide-6
SLIDE 6

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 6

11

Turbulent Air Flows

  • More than 20 air changes per

hour

  • Higher “ambient class”

recovery time than with the Unidirectional Flow, due to the lowest volume of air used

  • Excellent for transportable or

small size Isolators

  • Excellent when an inert gas

(Nitrogen, Argon…) must be used in alternative to the normal Air

  • Some areas can remain dirty

(non reached by the air flow)

HEPA Filter Air inlet Air outlet HEPA Filter Front view

12

Air flows evaluation

  • Turbulent flow

Isolator volume X number of air changes/hour 2 m3 x 20 air changes/ hour = 40 m3/hour 70.63 Cu ft x 20 air changes/ hour = 1,412 Cu ft /hour

  • Unidirectional flow

(area covered by the flow) x (air speed) x (3600 number

  • f seconds in a hour)

2 m2 x 0.45 m/s x 3600s = 3,240 m3/hour 21.52 Sq ft x 1.48 ft/s x 3600s = 114,658 Cu ft/hour

slide-7
SLIDE 7

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 7

13

2) Equipment Integration

  • Mechanical Integration
  • Cables/Electrical connections
  • Gaskets/Seals
  • Technical Area

14

Mechanical Integration

Different degrees of complexity : attention to all details!! Removable platforms. Rapid connectors for liquids. Electrical connectors for high vacuum applications. Remote electrical & control panels.

slide-8
SLIDE 8

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 8

15

Mechanical Integration

MAIN EQUIPMENT

  • Ex. Micronizator (Jet-Mill):

high dusts residuals and electrical sparks Closed environment with Nitrogen Atmosphere All electrical motors placed externally Completely Washable System

16

Mechanical Integration

Ergonomics and space constraints require advanced design studies!! UTILITY TYPE:

  • Gas, Liquid,
  • Electrical, Pneumatic
  • Temperature, Pressure
  • Aggressive Liquids,

Solvents/Acids SUITABLE MATERIALS:

  • PTFE, PVDF or Stainless Steel
slide-9
SLIDE 9

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 9

17

Mechanical Integration

MECHANICAL INTERFACES:

  • Flange interface (Very important!!)

The equipment is ready to be integrated into an isolator?

  • The equipment manufacturer has

to guarantee that the equipment is leak tight!!

  • The overall leak tightness should

not be compromised! Tests, LbM, Integration Expertise!!

18

Mechanical Integration : Retrofit

  • Working plane retrofit
  • Electrical panel retrofit
  • Lower Mechanical area retrofit
  • Check all crevices, and

connections from upper working plane to lower technical area, mechanical connections: Sealed? Washable? No passage of material from top to down: Pressurize Lower Mechanical Area

slide-10
SLIDE 10

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 10

19

Mechanical Integration

Over all process, not only mechanical but SW, One PLC and one HMI, I/O Exchange, Safety Interlocks, all the way to the stairs sheeting…

20

Cables/Electrical connection

Electrical Connector for vacuum applications avoid passage of air (Ex. Fisher, Douglas EC, type of connection) Rapid connectors for liquids such as Staubli (316L, with different gaskets from NBR to PTFE) All connections are a potential source of Leakage. High quality components should be a must!!!

slide-11
SLIDE 11

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 11

21

Gaskets/Seals

  • Static Gaskets Vs Pneumatic Gaskets
  • EPDM Vs Silicon
  • Custom Design Vs Standard

Cleanability and Leak tightness are critically dependant on the gaskets!!

22

3) Cleanability

  • Surfaces: Isolator Design and

Manufacturing

  • Valves and Piping
  • Suitable Equipment for WIP
  • Empirical tests for WIP Mock-up
slide-12
SLIDE 12

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 12

23

www.comecer.com

  • All of the internal angles should have a radius of curvature of

20mm to facilitate the cleaning and sterilization operations.

  • All welds are ground, smoothed, and polished.
  • All stainless steel components, welded using TIG method.

Surfaces: Isolator Design and Mfg.

24

Water Distribution System

  • VALVES:

Membrane/Diaphragm Valves VS. Butterly or Ball type

  • PIPING:

Stainless Steel With Full Pentration Weldings VS. Plastic piping All components should be suitable also for aseptic applications Avoid potential bacteria growth in the water distribution system!!

slide-13
SLIDE 13

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 13

25

Draining System

  • Sanitary Valve VS. Butterfly/Ball Type
  • Slope: Correct inclination >1%

26

Empirical tests for WIP Mock-up

slide-14
SLIDE 14

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 14

27

WIP Vs. CIP

  • The isolators can be dryed using hot

air(supplyed by a dedicated HVAC)

  • All circuits are self-drained
  • CIP? Fully automated recipes

(washing + drying) Capillary Effect to be considered, increases evaporation time, ex.: screws, rivets...

28

Summary

  • Efficient approach to Isolator project

requires particular attention to:

  • Correct integration of equipment into Isolators to ensure
  • ptimal containment.
  • Right choice of connection components, mechanical

interfaces and gaskets to minimize the risk of leaks.

  • WIP distribution systems details and components, to

ensure optimal drainage and cleanability and avoid cross contamination and bacteria growth.

slide-15
SLIDE 15

ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 15

Thank You!

Loris Rinaldi, Sales Manager Americas COMECER

429 Lenox Ave Miami FL 33139 (305) 606-6020 Lrinaldi@comecer.com