London BioLab SOP documentation for GLP and CL1

[bioscisam]

Hi,

At the moment at our Lab at the London Hackspace we are working toward establishing containment level one (CL1) standards. Our plan is then to go through the official procedure of notification to the UK government department that we are carrying out CL1 genetic modification work.
In short CL1 GM work includes creating organisms transformed with non-pathological functional constructs but beyond the limit of 'self cloning'.

For the purpose of inducting people into our lab we've set up a basic SOP documentation system which importantly contains information on laboratory and project risk assessments and best practices for equipment and method use.
Understanding the risks and communicating them to lab users is the main purpose of this documentation but as is typical in industry this is worked into a formal documentation system.

Here's the wiki link to the current contents: https://wiki.london.hackspace.org.uk/view/BioLabSOPs

We plan to also have these available on github in HTML format so that others can get hold of them of possibly consider using them as a starting point for creating their own documentation system to the same ends and possibly useful to any start-up lab company.

It would also be great to get feedback from the rest of the DIYBio/Biohacking community on this, especially from others that have or are trying to get to CL1 (I think called S1 in parts of Europe) , for instance on how the regulations vary by country.

Those of you who have done much work in labs may well be familiar with such documentation systems and probably hate them (or maintain a healthy indifference), but to do certain important aspects of molecular/synthetic biology with any amount of publicity the regulations in question mean we sometimes have to start acting a bit more like an established entity and follow the rules.

Looking forward to any feedback :)

Sam
London BioHackspace

[bioscisam]

Also, I forgot to add:

Anyone who wants to come and see our lab and chat to some of us about what we're up to is very welcome to come and visit. We have a meeting every Wednesday at the Hackspace lab, also Tuesdays are general Hackspace opendays.

https://wiki.london.hackspace.org.uk/view/London_Hackspace

Send a message to he...@biohackspace.org if you're in town!




Sam

[Yuriy Fazylov]

Here I thought SOPs were supposed to be idiot proof.
You will be using these to teach. Right?

[Cathal (Phone)]

Great! Sharing SOPs for the win, thanks guys!

For an Irish perspective, I put mine on github in Markdown, too: https://github.com/cathalgarvey/DIYbio-IE-SOPs

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[Pieter]

This reminds me that I should put the Dutch SOPs online some time soon too!

Cathal, in your SOPs you mention using toilet bleach for deactivation of biological agents:

• A strong oxygen bleaching agent for subsequent destruction of sporulated cells. i.e. Sodium percarbonate, toilet bleach.

In The Netherlands that's actually a violation of the biocide regulations for professional. I believe you must use special EU registered bleach instead.

Did you get any feedback on that in Ireland?

[Cathal (Phone)]

The EPA were quite happy with 10% bleach for liquid waste. I preferred percarbonate because it's more environmentally friendly and doesn't offgas chlorine. Specific regs vary: good to know that this isn't considered OK in Holland.

[Brian Degger]

Great work...
Guess it's almost time to start a Newcastle diy lab then.

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[Samantha Thompson]

Heya,

Not sure if anything in the lab is purely idiot proof. But the idea is
to approach something like 'damage limitation'.
Unfortunately, sometimes things that should be common sense need to be
made explicit, and we want (need) to have some kind of induction
procedure that explains these things to people. I think the aim really
is about getting people to realise the responsibility and taking
ownership of it.
I've worked in several GLP labs and a couple of ISO9000 labs and GMP
facilities so my approach might be overkill as the biohacking setting
is more like a small molecular biology research lab in scope/usage.
However these kinds of labs always at least have some kind of GLP
based/compliant system in place, which tends to come back to having an
SOP framework.

Anyway, in summary if it helps others that trying to set up labs that
are not in the established academic/industrial research/diagnostics
community then that's good :)
It also helps me to understand these things better which I've taken
for granted in industry/academia by helping others to figure it out.

Sam

On Thu, Nov 27, 2014 at 5:18 AM, Yuriy Fazylov <yuriy...@gmail.com> wrote:
> Here I thought SOPs were supposed to be idiot proof.
> You will be using these to teach. Right?
>

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[Samantha Thompson]

Thanks, this is an awesome resource and I've probably unnecessarily
repeated a lot of what you've got here.
That said it's reassuring to see the same themes being addressed,
everything from spillages to GMM identification and risk assessments.
Nice work! :)

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[Brian Degger]

Nothing is ever idiot proof.
Each year for maker faire, we need to fill out a risk assessment form.
The importance of this is you display you know the risks & hazards and
ways you are minimising them. (and communicating them)

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http://makerspace.org.uk
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