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Why PharmaConsult US?

Julian WilkinsPrincipal

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Experience

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Five Years of Successful Projects

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Look Who We Helped

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The PharmaConsult US Difference

• Containment is all we do• We are TOTALLY independent – our

recommendations are truly impartial• You deal directly with the principals throughout

the life of your project• Our designs incorporate the technology best

suited for your project• We deal with OSD, API and parenteral processes

daily• The volume of projects we undertake allows us

access to a range of data that can assist you

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Typical A/E Document

• Description of Operation:• Material is brought into the isolator in a small fiber pack drum via the

pass through or the bag connection. Material is subdivided into batch quantities. If material remains in the fiber pack drum container, the drum is removed by bagging out the drum. If the drum is empty, the drum is disposed of. Once the fiber pack drum is removed, the subdivided material containers and isolator are decontaminated. After decontamination, any waste is bagged out of the isolator, and then subdivided material is removed via the pass through.

• General Notes• The equipment vendor is responsible for the design of the

equipment.• The Isolator and its components are to be completely mounted and

wired. The Isolator must be easy to clean.• Vendor shall quote cost to provide a mock-up of the isolator for

ergonomic testing and approval at the site

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Typical PharmaConsult US Documents

User Requirements Specification for

API PROCESSING ISOLATORS AND RELATED SLURRYING VESSELS/ OVENS

1 vendor 2 Area for control panels for isolator/filter dryer/ process. A fully integrated unit is

preferred. Data recording should be real time to a 10 channel strip recorder. The channel allocations will be advised at time of order.

3 HMI panels on 10° sloping fascia 4 Precipatory vessel 5 Chamfered corner for easy cleaning. With 13 provides space for utility and process

runs 6 Chamfer and space between chamber and shroud for utility runs 7 Door to precipatory vessel chamber

1.1.1 Pack off Plug Detail The device is a tube with a means of connection using a standard screwed union. The tube is closed off using a ball valve. To improve the containment during charging the pack off is mounted in a chamber of the isolator dedicated to the purpose. The pack off is screwed into a nozzle mounted in the pack off chamber. This nozzle is closed off to the isolator via a plug, which when not in use has the non-exposed side protected by a tack pad. With the pack off mounted in place, a funnel is inserted and the product is introduced via the funnel. The funnel is a machined tolerance fit and has O-rings to seal it in place, which when inserted occludes the mounting nut and ball valve.

Sketch 1 Sketch 2 Sketch 1 shows the pack off in the closed position. The plug (1) is in place and is sealed by means of the O-ring. The handle is recessed so that the work surface is clear of obstructions. The 316L

1.1.1 Bagging tubes

Requirements for bagging tubes

1. Machine plastic Delrin or similar 2. 316 L stainless steel 3. Smooth all sharp edges ground smooth. No crevices 4. Typical bagging rings are made from 3/8” diameter bungee cord

Lay Flat Tube Standard US Sizes

# Layflat Circumference Diameter A B 8 8” 16” 5.09” 4.89” 4.09” 10 10” 20” 6.36” 6.16” 5.36” 12 12” 24” 6.91” 6.71” 5.91” 14 14” 28” 7.63” 7.43” 6.63” 16 16” 32” 10.18” 9.98” 9.18” 18 18” 36” 11.45” 11.25” 10.45” 20 20” 40” 12.73” 12.53” 11.73” 22 22” 44” 14.0” 13.8” 13.0”

• User Requirements Specification Defines the particular requirements and the specific specification required.

• It contains detailing that is required and also contains or references the General arrangement drawings and P&ID

• It is in the GAMP JETT format

1.1.1 Isolator Design see GA and P&ID for locations

# Item Requirement 1.1.1.1 Structure and Shell a Chambers 316L Stainless Steel, ≤15 Ra finish or better. All

angles and corners are coved to minimum 5/8” radius. All welds ground smooth and crevice /defect free. Externally ≤ 35 Ra Includes air plenums.

b Support Structure 304 Stainless Steel ≤ 35 Ra c Cover / Access Panels 304 Stainless Steel ≤ 35 Ra 14 Gauge d Sensors:

Materials of Construction

Should be externally located where possible. Or Cleanable, cGMP compliant materials, VHP resistant and non oxidizing and must not compromise sterility. Sensors should be provided with splitters to segregate control and data recording functions.

1.1.1.2 Doors and Gull Wings Doors must hinge open to allow access to the interior, a Gas struts A means to safely hold the gull wing door where

specified, open without risk of injury is to be provided. The gas strut must be outside the contained boundary and will be concealed

b Where doors provide access to process equipment and the door is part of the safety guarding the door is to be suitably interlocked.

1.1.1.3 Glazing and Frames a Glazing 3/8” laminated safety glass b Glazing Frames for

Opening Panels

A frameless system is preferred with flush internal, crevice free finish and seals A framed system may be offered so long as it is crevice free and has no visible bolts Or Frameless glass panels with mounted hinges and lock plates mating to “U” gasket on knife edge The glazing has to provide visibility to all areas of the enclosure. Opening panels have to be provided to provide full access to equipment for set up, cleaning, and maintenance

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Project Deliverables

Options and Recommendations

Determine Processand Objectives

Ergonomic Review

Risk Assessment

Design Development User Requirements Specification

FAT / SATFunctional TestIQ OQ Protocols

Bid documents T&C’s

TrainingVendor Documentation

Vendor Selection

Bid Process

Order

Vendor Management

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Detail, Detail, Detail

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Ergonomics Proof of Concept, Proof of Detail and Execution

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Ergonomic Review Prior to Bid

• Undertaking full ergonomic and functional evaluations as part of the detail design is essential prior to bidding and awarding the project

• We have shown time after time that it saves time and cost and results in comparable bids

• $7,000,000 in containment projects were executed this way by PharmaConsult in 2004

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Design Development Concept to Completion

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Detail Design

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Training

• Hands on technique, operation and maintenance training

• Videos• Power Point

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Cost

Annual Total0Reusable see cycle time0.00Intermediate Bulk Container (IBC)

Annual Total0Disposable0.00Flexible Intermediate Bulk Container (FIBC)

Annual Total1,000size of largest normal Fiber drum5.00Drums and Kegs

Annual Total0small lock chamber pass ins0.00Small Containers and bags under 10 Kg

Type of containerrs for feeding the system best guess estimation

Values below are calculated25.0030.00Labor Cost/Hr all inclusive

$ CFM per Annum10.008.00Cost of recirculated air

80.000.00% Recirculated air

CFM per year14.0014.00Cost of Pharmaceutical once through air

%20100% new air in Downflow options

Used with the cost of HVAC 86408640Time air handling system is on (Hours)

Used to asses turn round cost10Product to product change outs

Used to asses clean cost50In campaign cleans

Used in operational cost assessment200Batches

UnitsTotalsNotesDefault ValueAnnual TotalItem

Batch and Product change out data used to approximate the scale of usage

Cells with red triangles contain notesGood approximationsBasic requirement data

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Costs

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

7 Multiple use glove bag ECA 3

6 Single use glove bag ECA 3

5 Lock or bag in Containment valve pass out CIP Automated ECA 4

4 Lock chamber in bag out isolator ECA 4

3 Downflow Booth physical segregation ECA 3

2 Downflow booth procedural segregation ECA 1/2

1 LEV ECA 1/2

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Containment the Reality

• Is all about preventing contamination, cross contamination and mix ups

• Containment can lead to significant cost savings• Containment assists in risk assessments• By designing a redundant system catastrophic events can

be prevented• Because we have a system that addresses regulatory,

risk and cost containment, we incidentally protect both people and the environment

• Process Containment makes business sense

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Why PharmaConsult US?

Experience!