Copy Of Brieftq - Psl

Client - GSk Singapore Project - PB2 Solid charging containment project. Equipment - High containment isolators Vendor - PSL . Proposal Ref: E3740.000 Budget quote M-Mandatory,O-optional,G-cGMP,E-EHS S.No 1

URS - JES Single Chamber Isolator Stainless Steel 316L for both charging and drum loading chambers. All rounded internal surfaces not less than 18mm radius.

Status M,G,E

Vendor Proposal Monocell dispensary,double chamber system,Single chamber 3 port glovebox

Isolator can copeup with 100-400kgs of powder transfer

Comments Vendor's response Clarification required. Is drum lid removed inside chamber? Cannot remove outside as drum or bag may be dusty. Drum external & lid cleaning will make charging a long process.

How material transfer is done into charging chamber before dispensing?explain transfer methodlogy. Will the space be sufficient to hold 400kgs? all transfer should be before dispensing commences to take care of contaiment issue clarify.

2 Basic Dimensions see E3740B02 E3740B02 drawing (GA drawing) required 3

RTP port. 270mm Preferred size for large bags, used bags, tools and filters.

M,G,E

Bagout port 250 mm diameter with OPTIONAL 190 RTP to replace it

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Front Vision Panels and Oval Glove ports size 10”.

M,G,E

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Nitrogen Purge System and sweep not less than 8 ACH

M,G,E

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Single HEPA Inlet and Double HEPA Exhaust safe change system filters including DOP sampling connections, interlocked Pressure Differential control. Push / Push. Isolator chamber internal CIP spray wand and spray balls to ensure total coverage and cleanings.

M,G,E

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O,G,E

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Valving, Instrumentation, Piping Systems, Audio Visual Interlocked Alarm systems, Power and Utility Hook-up Points. Dedicated Extract Fan to be located in the technical area and MCC and logic relay panels located in the safe area. (Danfoss VSD, Extract Fan, safe area panel supply shall be by Isolator Vendor) N2 Pressure Regulator valve, needle valve and actuated Isolation valve

M,G,E

Suitable Actuated Isolator discharge valve for interface GLMS equipment rated to 6.6 barg Loose swivel flange at termination for mobile option Load isolation to be provided to prevent interference of Isolator with reactor load cells on all reactors.

M,G,E

Mock up Ergonomic trials in GSK Singapore Jurong site

M,E

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Additional points for clarification N/A

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N/A

We need double HEPA on extract as per URS Kindly confirm.

2 off Manual Wash hoses. Manual only isolation valves. No manifold pipework. 2 off Cip spray ball. Manual only isolation valves. No Keeping in view the high containment level CIP, with spray ball, manifold pipework shall be automated and shall be in vendor's control system with necessary DCS interface. Draining to be taken care of with DCS interface for draining into Reactor One off ATEX plug and socket for mobile glovebox. if the glove box is mobile - DCS needs to know on which reactor Glovebox with 5 metre cable and plug the glove box is connected. Vendor to configure this interface this would call for multiple sockets - include 4 sockets for costing Kindly confirm whether this requirement is taken care of.

M,G,E

Dedicated variable speed remote extract fan 240 m3/hr.Painted mild steel in Technical area

Confirm Glove breach interlock to achive a 0.5 m/sec air flow into Isolator is through VSD, controlled by Vendor control panel.

M,G,E

nitogen purge feed system with axtuated valve and orifice plate.

Vendor to include Nitrogen purge regulation in his scope. Automated purge with Nitrogen and change over to Air shall be considered. Actuated charge point with interrface to DCS shall be provided.

O,G,E M,G,E

Discharge via 150 mm PTFE flexible and 150 mm stainless steel/pom body passive chargepoint. Flexible and chargepoint allow make/break from glovebox to vessel Wooden model mock up for approval meeting

Dispensing scale to +/- 0.001 kg

Dispensary operation Pressure Rated 150 mm active to be sited on vessel.

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Is Air purge not required for maintanence operations? Kindly clarify and include with regulation.

M,G,E

Power and Utility Hook-up Points Tri-clamp connections, control and power connection plugs with feedback to DCS to determine location, if mobile

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Nitrogen purge feed system with actuated valve and orifice plate

Inlet Hepa on nitrogen line 205 x 205 mm EU13 Hepa

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Glass/acrylic fixed window 3 port x 300 mm Elliptical gloveports with Hypalon gloves

Is it either 190 RTP( Pg 7/17) or 270 mm RTP(P 13/17) as given in your proposal. 190 RTP to be included in addition to bag out port. Optional Costing requirements for this combination? Toughened and laminated glass required. Provide optional cost.

Drum lifter to handle 30 L and 60 L Mauser drums

This requirement shall be included in Vendor scope Confirm whether the glove box interface with Active charge point is horizontal. What is POM body? Confirm this cost is inlcuded in the base offer.

Why do we need this for Isolator option? How are weights upt to 400 kgs measured and into what containers? Dispensary glovebox(es) is in a different building and dispense to various size containers not a reactor. Active valve wetted parts - Hastealloy C-22/PTFE Passive valve wetted parts - SS316L/PTFE Drum docking to Isolator: when to lid-off - inside or outside Glove box? Confirm the drum lifter control for required docking will be in vendor control panel and interlocked with seal inflation and enable sliding door open. Confirm whether drum of different capacity and different lid size can be accommodated by the glovebox in the same charging operation or modifications have to be made. What about 20kg sacks?