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To:
Subject:
Date:
Attachments:
Jackowiak, Linda
Gates, Matthew (BSI Services and Solutions East Inc.)
RE: Alestra Microwave Peptide Synthesizer
Thursday, April 30, 2020 12:10:36 PM
image001.png
Ok here is the data to include in your MOC/RA for this item related to IH and ADC safety
Summary: The Biotage Alstra Microwave Peptide Initiator/Synthesizer Unit proposed for purchase
and location within a ventilated enclosure within the ADC Suite was not found to pose an additional
risk to facility or employees, if used as described. Although similar to a unit currently onsite (Biotage
Innovator+), this unit is not a like for like replacement. Two items require additional action:
evaluation of the need for additional air flow (removal capabilities) from the ventilated enclosure
and the new location of the current unit being upgraded/replaced, which will remain in use. Both of
these are under current evaluation by the Industrial Hygiene Group.
Exposure Evaluation
The Biotage Alstra proposed for use is similar to the unit (Biotage Innovator+ ) already in use
and being used in containment within the ADC Suite.
Components loaded into the unit are heated up for faster reaction (but no differently than the
previous version)
Liquid materials being loaded into this unit are not different from the previous unit it replaces,
with the exception of having “open vials”
Materials in use in this unit are not flammable, explosive, and/or do not pose a risk of
fire/explosion/significant off gassing or evaporation from conditions created during this
process.
This unit is proposed to be used within that same containment device as the earlier unit, and
will replace that unit as the sole device operating within that containment unit.
The Alstra, while functionally the same operation as its predecessor (Innovator+), has some
differences:
The unit is larger, by approximately 8” x 10” due to the addition of a vial feed tray on
the right of the instrument
It will require feed bottles be placed within the containment, also taking up additional
space within the containment
The vials are open, but based on the process should not readily aerosolize.
The unit allows for multi vial staging (in the tray) but still only acts on 1 vial at a time.
The source of microwave and vial being heated are enclosed during the process to
prevent exposure.
Frequency of use will not change, but the number of samples that can be staged has
significantly increased (vial volumes are not significantly different but the number that
can be present/staged has changed)
Evaluation of the specs, vendor manual, interview with Raffaele Columbo (user), and visual
observation of the location for the existing unit and proposed location for the new unit produced the
following statements:
Operationally, this unit is not significantly different from the previous unit, except for size and
number of vials present.
The primary concern with purchase and use of this unit was effective containment, based on
the increased size of the unit and open vial system.
Mock up of the size/shape of the unit and set-up was performed in the proposed containment
location to determine if effective containment could be achieved
With the mock up in-place the unit was smoke tested and evaluated.
The unit maintained containment, but was slow to perform removal from within the unit
(observation of some lingering smoke)
It is believed that with a potential increase in air flow the lag time for removal can be
decreased.
The existing unit (Biotage Innovator+ ), which will continue to be used, will need to be
evaluated to determine if containment is required. If containment is required, the location
and placement will need to be evaluated by IH.
Please note the change to my email address…
Linda Jackowiak
Chemical Safety and Industrial Hygiene Manager
Gaithersburg Safety Health and Environment (GBSHE)
OMW 2238 F
linda.jackowiak@astrazeneca.com
(301) 398-0075 - O
(202) 590-7936 - M
To the extent this electronic communication or any of its attachments contain information that is
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From: Gates, Matthew (BSI Services and Solutions East Inc.) <matthew.gates@astrazeneca.com>
Sent: Wednesday, April 29, 2020 3:32 PM
To: Jackowiak, Linda <linda.jackowiak@astrazeneca.com>
Subject: RE: Alestra Microwave Peptide Synthesizer
Hi Linda,
I hope you are doing well! When you have a moment could you get back to me on this please?
Thank you,
Matthew Gates
From: Jackowiak, Linda <linda.jackowiak@astrazeneca.com>
Sent: Friday, April 10, 2020 9:56 AM
To: Gates, Matthew (BSI Services and Solutions East Inc.) <matthew.gates@astrazeneca.com>
Subject: Re: Alestra Microwave Peptide Synthesizer
I’ll send you something.
Sent from my iPhone
On Apr 10, 2020, at 9:53 AM, Gates, Matthew (BSI Services and Solutions East Inc.)
<matthew.gates@astrazeneca.com> wrote:

Hello Linda,
Any information on this regarding the smoke testing you conducted or other important
safety information regarding the Alestra?
Thank you,
Matthew Gates
From: Gates, Matthew (BSI Services and Solutions East Inc.)
Sent: Friday, April 3, 2020 10:09 AM
To: Jackowiak, Linda <linda.jackowiak@astrazeneca.com>
Subject: RE: Alestra Microwave Peptide Synthesizer
Hi Linda,
Could you get back to me on this when you have a moment?
Thank you!
Matthew Gates
From: Gates, Matthew (BSI Services and Solutions East Inc.)
Sent: Friday, March 27, 2020 12:20 PM
To: Jackowiak, Linda <linda.jackowiak@astrazeneca.com>
Subject: FW: Alestra Microwave Peptide Synthesizer
Hello Linda,
I have an MOC in the pipeline for these devices in the ADC suite, has a TrackWise entry
been made for this case already?
Thank you!
Matthew Gates
From: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Sent: Wednesday, March 25, 2020 2:14 PM
To: Gao, Changshou <changshou.gao@astrazeneca.com>; Gates, Matthew (BSI
Services and Solutions East Inc.) <matthew.gates@astrazeneca.com>
Subject: RE: Alestra Microwave Peptide Synthesizer
Hi Matthew,
See conversation below. Let me know how I can support in finalizing the approvals.
Best,
Raffaele
From: Colombo, Raffaele
Sent: Friday, March 13, 2020 10:00 AM
To: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>; Jackowiak, Linda
<linda.jackowiak@astrazeneca.com>
Cc: Damschroder, Melissa <melissa.damschroder@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
Hi Everyone,
I just met with Linda.
Here some notes:
Lab 4651 is at capacity for ventilation. SHE is working in having an assessment
from an external expert.
We proposed that the instrument we current have in an enclosure (Biotage
Initiator) which works in a close environment (close vials and close reactor) and
is used for synthesis of organic building blocks (not ADCs) could be moved out on
a bench in the ADC lab 4651. The new instrument (Biotage Alstra) could be
installed in the enclosure, since it requires ventilation (open vials).
SHE will take a look of the specs for Biotage Initiator and Alstra.
SHE will run a smoke test of the enclosure filled with racks and bottles to mimic
the configuration of the new instrument.
New meeting to discuss this on March 23rd.
Feel free to add if I missed something.
Thank you all for the help in getting this done.
Best,
Raffaele
From: Colombo, Raffaele
Sent: Wednesday, March 11, 2020 10:56 AM
To: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>; Jackowiak, Linda
<linda.jackowiak@astrazeneca.com>
Cc: Damschroder, Melissa <melissa.damschroder@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
Hi Linda,
Do you have any update regarding this?
Let me know if you need more information. We’d like to move forward with the vendor
as soon as possible to avoid delays in projects.
Best,
Raffaele
From: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Sent: Thursday, March 5, 2020 11:08 AM
To: Jackowiak, Linda <linda.jackowiak@astrazeneca.com>
Cc: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Subject: FW: Quote 14935 RFI questions (CER-02405)
Linda,
Per the safety meeting yesterday all new equipment was put on hold until the exhaust
system assessment was completed and resolved in the ADC Suite 4651. When this CER
was originally pitched it was under pretext that a new exhaust enclosure system would
be needed to support it.
After speaking with Raffaele and the Biotage engineer they have proposed an
alternative solutions that you may some more insight to if it is acceptable.
Attached is the current layout and 2 options that “should not” require additional
exhaust to support based on my basic knowledge of that area. Obviously this would
need to be sent up the chain for additional approval if one is an acceptable solution.
Thanks,
Jonathan
From: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Sent: Thursday, March 5, 2020 10:05 AM
To: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
Hi Jonathan,
Thanks. Then the only option is to move the one we have and install the new one
where the current one is.
Can we proceed with this option? Do you have 5 min to meet the rep?
Best,
Raffaele
From: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Sent: Thursday, March 5, 2020 10:00 AM
To: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
Morning Raffaele,
I had a meeting with safety yesterday, they will be addressing the ADC area going
forward for now. Based on our conversation and the information I provided from our
site survey, 4651 is currently maxed out on available exhaust and cannot support any
addition equipment that utilize the exhaust system.
Until this resolved I cannot proceed further with my site survey. I have all the
information I need for now from the email I received from the vendor and our meeting.
Once I get the green light from all parties involved I will reach out to you.
Jonathan From: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Sent: Thursday, March 5, 2020 9:17 AM
To: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
Hi Jonathan,
A rep from Biotage is going to be on site in 15-20 min. Are you available to meet to
discuss the logistics with him?
Maybe around 9:45-10:00?
Sorry for the last minute notice but I just found out
Best,
Raffaele
From: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Sent: Tuesday, March 3, 2020 2:26 PM
To: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
Raffaele,
So per the information below, it is highly recommended that you have it in a fume
hood. Now the question becomes as you mentioned during our meeting, do you want
to:
Replace the existing Biotage unit with the CAPEX new one
Purchase the fume hood in the location we discussed
Would need a OMW facilities assessment to see if there is existing
exhaust above bench or can be tied in.
If exhaust needs to be install, price may be attached to CER.
Let me know your thoughts
Jonathan
From: 1-PointSupport US <US-1-Pointsupport@biotage.com>
Sent: Tuesday, March 3, 2020 12:54 PM
To: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Cc: Logan Shain <Logan.Shain@biotage.com>; 1-PointSupport US <US-1Pointsupport@biotage.com>; Adam Gould <adam.gould@biotage.com>; Colombo,
Raffaele <raffaele.colombo@astrazeneca.com>
Subject: RE: Quote 14935 RFI questions (CER-02405)
CAUTION: This email originated outside AstraZeneca. Do not open the attachment(s) unless you
recognize the sender and know the content is safe.
Hello Jonathan,
I was able to get a copy of the RFI from my sales group. I’ve noted the answers below.
• Regarding line 1 “Alstra” module
·
Do the dimensions included in the RFI include this module being attached?
YES
• Regarding line 2 “Vacuum pump ME1C”
·
Does this require exhaust connection while running? The RFI says no but I
wanted to verify as it would require us possibly modifying a lab to
accommodate this. NO, but the RFI also recommends a fume hood “It is
not required but highly recommend to have the system in or adjacent to
a well ventilated environment.”
I’ve attached a few documents which may help you with your certification:
·
Alstra Installation and Safety Guide
·
Alstra Getting Started Guide
·
Alstra Quick Guide
·
Alstra Installation Check List
Please let me know if you have any questions.
<image001.png>
Edward S. Johnson
Technical Support Specialist
Biotage
Charlotte, NC
Technical Support: +1 800 446 4752 Option #3
Direct: +1 704 654 4832
Fax: +1 707 248 1541
edward.johnson@biotage.com
US-1-pointsupport@biotage.com
www.biotage.com
<image002.jpg>
<image003.jpg>
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From: Calhoun, Jonathan <jonathan.calhoun@astrazeneca.com>
Sent: Tuesday, March 3, 2020 8:33 AM
To: 1-PointSupport US <US-1-Pointsupport@biotage.com>
Cc: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Subject: Quote 14935 RFI questions (CER-02405)
To whom it may concern,
I received the RFI for quote 14935 and have a few questions
Regarding line 1 “Alstra” module
Do the dimensions included in the RFI include this module being
attached?
Regarding line 2 “Vacuum pump ME1C”
Does this require exhaust connection while running? The RFI says no but I
wanted to verify as it would require us possibly modifying a lab to
accommodate this.
Could you please provide any technical documents for this equipment. We will
need to arrange for the equipment to receive NRTL certification following its
purchase, these documents would be beneficial for the engineer performing the
certification.
Thank you,
Jonathan Calhoun
701-389-7805
From: Gao, Changshou <changshou.gao@astrazeneca.com>
Sent: Wednesday, March 25, 2020 1:57 PM
To: Gates, Matthew (BSI Services and Solutions East Inc.)
<matthew.gates@astrazeneca.com>
Cc: Colombo, Raffaele <raffaele.colombo@astrazeneca.com>
Subject: RE: Alestra Microwave Peptide Synthesizer
Sorry for my late response. I missed your previous email.
Raffaele: Could you please get back to Matthew? Thanks.
Changshou
From: Gates, Matthew (BSI Services and Solutions East Inc.)
<matthew.gates@astrazeneca.com>
Sent: Wednesday, March 25, 2020 1:25 PM
To: Gao, Changshou <changshou.gao@astrazeneca.com>
Subject: RE: Alestra Microwave Peptide Synthesizer
Hello Changshou,
When you have a moment could you get back to me on this? If you know when the
device is to be delivered that would be very helpful for myself.
Thank you,
Matthew Gates
From: Gates, Matthew (BSI Services and Solutions East Inc.)
Sent: Monday, March 9, 2020 10:35 AM
To: Gao, Changshou <changshou.gao@astrazeneca.com>
Subject: Alestra Microwave Peptide Synthesizer
Hello Changshou,
I recently received a management of change notification for your ordered Initiator +
Alestra – Microwave synthesizer. I am assigned to look into the intake of this device
and determine if any SHE action is necessary upon its arrival. Who would be the best
point of contact for this device?
Thank you!
Matthew Gates
Safety Specialist | BSI Services and Solutions East Inc.
Gaithersburg Safety, Health & Environment (GBSHE)
Working on behalf of AstraZeneca
One Medimmune Way 2240D | Gaithersburg, MD 20878
Cell: 240-480-4674
Matthew.Gates@astrazeneca.com