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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 URS - JES Status Vendor Proposal Comments Vendor's response


1 Single Chamber Isolator Stainless Steel 316L for both M,G,E Clarification required. Is drum lid removed inside chamber?
charging and drum loading chambers. All rounded Monocell dispensary,double chamber system,Single Cannot remove outside as drum or bag may be dusty. Drum
internal surfaces not less than 18mm radius. chamber 3 port glovebox 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
Isolator can copeup with 100-400kgs of powder transfer
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 M,G,E
bags, tools and filters.

Bagout port 250 mm diameter


with OPTIONAL 190 RTP to replace it
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?
4 Front Vision Panels and Oval Glove ports size 10”. M,G,E Glass/acrylic fixed window Toughened and laminated glass required. Provide optional cost.
3 port x 300 mm Elliptical gloveports with Hypalon gloves

5 Nitrogen Purge System and sweep not less than 8 M,G,E


Nitrogen purge feed system with
ACH Is Air purge not required for maintanence operations? Kindly clarify
actuated valve and orifice plate
and include with regulation.
6 Single HEPA Inlet and Double HEPA Exhaust safe M,G,E
change system filters including DOP sampling
Inlet Hepa on nitrogen line 205 x 205 mm EU13 Hepa
connections, interlocked Pressure Differential control. We need double HEPA on extract as per URS Kindly confirm.
Push / Push.
7 Isolator chamber internal CIP spray wand and spray M,G,E
balls to ensure total coverage and cleanings.
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
8 Power and Utility Hook-up Points Tri-clamp O,G,E One off ATEX plug and socket for mobile glovebox. if the glove box is mobile - DCS needs to know on which reactor
connections, control and power connection plugs with Glovebox with 5 metre cable and plug the glove box is connected. Vendor to configure this interface this
feedback to DCS to determine location, if mobile would call for multiple sockets - include 4 sockets for costing

9 Valving, Instrumentation, Piping Systems, Audio M,G,E Kindly confirm whether this requirement is taken care of.
Visual Interlocked Alarm systems, Power and Utility
Hook-up Points.
10 Dedicated Extract Fan to be located in the technical M,G,E Dedicated variable speed Confirm Glove breach interlock to achive a 0.5 m/sec air flow into
area and MCC and logic relay panels located in the remote extract fan 240 m3/hr.Painted mild steel in Isolator is through VSD, controlled by Vendor control panel.
safe area. (Danfoss VSD, Extract Fan, safe area Technical area
panel supply shall be by Isolator Vendor)
11 N2 Pressure Regulator valve, needle valve and M,G,E nitogen purge feed system with Vendor to include Nitrogen purge regulation in his scope.
actuated Isolation valve axtuated valve and orifice plate. Automated purge with Nitrogen and change over to Air shall be
considered.
12 Suitable Actuated Isolator discharge valve for M,G,E Actuated charge point with interrface to DCS shall be provided.
interface GLMS equipment rated to 6.6 barg
13 Loose swivel flange at termination for mobile option O,G,E This requirement shall be included in Vendor scope
14 Load isolation to be provided to prevent interference M,G,E Discharge via 150 mm PTFE flexible and 150 mm Confirm whether the glove box interface with Active charge point is
of Isolator with reactor load cells on all reactors. stainless steel/pom body passive chargepoint. Flexible horizontal.
and chargepoint allow make/break from glovebox to What is POM body?
vessel
15 Mock up Ergonomic trials in GSK Singapore Jurong M,E Wooden model mock up for approval meeting Confirm this cost is inlcuded in the base offer.
site

Additional points for clarification


16 N/A Dispensing scale to +/- 0.001 kg Why do we need this for Isolator option?
How are weights upt to 400 kgs measured and into what
containers?
Dispensary operation Dispensary glovebox(es) is in a different building and dispense
to various size containers not a reactor.
17 N/A Pressure Rated 150 mm active to be sited on vessel. Active valve wetted parts - Hastealloy C-22/PTFE
Passive valve wetted parts - SS316L/PTFE
18 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.
19 Drum lifter to handle 30 L and 60 L Mauser drums 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?

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