QUESTIONSA0002.docx

Good Morning, Please advise: (please answer to red questions below and if possible please extend the deadline.)

8. Connections

a. Shall be stainless steel

b. Connections shall be push valves (Quick Connects)

c. Shall be autoclavable at minimum of 121C Zero dead leg flanges are used for industrial scale BIOREACTORS in order to connect anything (Probes, Valves…) to the vessel. Any connection with the vessel will be TRI -CLAMP ASME BPE. Please confirm.

For push valve connection, will a tri clamp / push valve adaptator (see picture below) be acceptable ?

Can you please be more specific about this push valve connection ?

10. View glasses

a. One shall be located on top of vessel and one shall be located front of vessel

11. Temperature sensors

a. Shall be located in headspace

b. Shall be located in condenser

c. Shall be located in exhaust filter

12. Steam inlet in headspace shall be manually controlled

13. Ports

a. Inoculation Ports – Require 3 (Will they be for the inoculation with the syringe with the membrane?. How will they be sterilized before inoculation (with the alcohol?) and 1 (Will it be sterilized before inoculation with the alcohol or steam?) shall be as large as the harvest port

b. Harvest Port – No more than 1, diameter shall be at least 3/4 inch. How the harvesting is going to be done? At the bottom or at the top ? If at the bottom, can a diaphragm zero dead leg bottom valve be used ?

Sample Port – No more than 1 How the sample will be collected ? Option A or option B?

A

B

Please confirm urgently.

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