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Self and Hasty  
#1 Posted : 21 May 2019 16:06:02(UTC)
Rank: Forum user
Self and Hasty

Hello all,

I've taken the job in London, but I have 4 weeks in my current role to try and fix as much as I can.

I've asked the QA/QC/R&D on site but haven't got any answers so I thought I'd try my peers on here...

As I was doing a Risk Assessment for bleachy mop water being hand-carried from the asceptic unit through the warehouse, up some stairs, down a corridor into another building to the toilets where it is poured down the sink...

Other than the obvious manual handling and COSHH concerns with this practice when I starting delving a little deeper I discovered that not only is there a potential for there to be cytotoxic chemicals in the mop water aswell as bleach and dirty water, but there was in fact evidence of cytotoxics in the mop water nearly twice the acceptable on site limit (0.914ug/cm2 found on the floor that is checked annually when the ALARA limit for the site is 0.47ng/cm2 - I have no idea where this figure has been calculated, it seems pretty arbitary to me.)

I have spent a lot of today trying to find;

-Exposure Limits to cytotoxics -Dilution of cytotoxics to be inert/safe for exposure, or safe for disposal down main drains

And I have come up with nothing...

Does anybody have any idea on Cytotoxics disposal, dilution and exposure limits?

Thanks in advance

Redders  
#2 Posted : 21 May 2019 22:21:35(UTC)
Rank: Forum user
Redders

Cytotoxics covers a whole host of pharmaceuticals and I'm sure there could be any 'safe' limits through dilution. I've also never come across ALARA  

There are also detergents that neutralise different groups of cytotoxics but I wouldn't be able to recommend any specific products. This would get around the problem of contaminated mop water, particularly if you have the means to demonstrate neutralisation through testing.

In the meantime, I would advise you contact the local water company for advice on discharge of contaminated mop water to the sewer. With evidence of contamination, I'd be very surprised if a consent to discharge was granted by them.

This may create a whole load of problems and may not be included in your 'fixed list' when you leave!

ttxela  
#3 Posted : 22 May 2019 08:06:05(UTC)
Rank: Forum user
ttxela

I'd definitely agree with contacting your water/sewerge company for advice, maybe double check what your trade effluent consent covers first. The catchment scientist is the chap you want to speak to.

In my experience although manufacturers SDS etc. may often say disposal to drain is OK the catchment scientist may take a different view!

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Self and Hasty on 24/05/2019(UTC)
Benz3ne  
#4 Posted : 22 May 2019 15:33:23(UTC)
Rank: Forum user
Benz3ne

I agree with the suggestion of checking SDS or contacting suppliers/manufacturers of cytotoxics, and perhaps look for professional advice on use of/cleaning of/operating in asceptic units. I'm surprised that there's such freely moving items into/out of the asceptic unit (i.e. a dirty mop bucket) where everything else should be so stringent (clean downs with peracetic acid, ammonia, peroxides etc., having to wear overshoes, use of items which have been sterilised, no makeup or jewellery... etc).

The SDS will have disposal considerations in section 13. Sometimes these can be a little vague but allude to use of licenced disposal companies, which is what I'd envisage rather than 'down the sink'.

Dilution may work, but may require 100's of L of water to reach any worthwhile dilution. 

Companies who undertake biological sampling or occy health surveillance may be able to advise on limits if drugs exposures are their field of expertise. I know NHS has on-site asceptics and cytotoxics in their chemo pharmacies in some hospitals, so perhaps a quick call to them might be able to point you in the direction of whoever they use? Or information on specific cytotoxic drugs?

Lastly, the page on HSE for handling cytotoxics points naturally towards the ACOP for COSHH, so treat it as any other chemical for the time being. Ensure no dermal or inhalation exposure for 'unknown' chemicals - i.e. treat as toxic (which, in fairness, they probably are).

I'll ask my SO about her practices - she, coincidentally, works in an asceptic unit in a hospital, dealing with preparation of chemo drugs and cytotoxics.

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Self and Hasty on 24/05/2019(UTC)
stevedm  
#5 Posted : 23 May 2019 03:03:49(UTC)
Rank: Super forum user
stevedm

You might also find ths HTM useful...it si more geared towards the transporttation but cvers handling and waste disposal..

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/167976/HTM_07-01_Final.pdf

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Self and Hasty on 24/05/2019(UTC)
A Kurdziel  
#6 Posted : 23 May 2019 10:35:08(UTC)
Rank: Super forum user
A Kurdziel

Cytotoxic is not really a Health and Safety term, it’s a pharmaceutical term to describe certain substances that can enter a cell and destroy them for the inside. As far as CLP and COSHH go the term would be Toxic, Highly Toxic and maybe Harmful. There are no occupation exposure standard other than those in EH40 which essentially cover respiratory hazards.  0.47 ng.cm-2 is very low but it depends on what you are dealing with. Are you referring to ng.cm-2 which is over surface area (floor bench) or per cubic centimetre which is a volume (of let’s say mop water)

So it could be conceivable but it as you said could be totally arbitrary. How you come to that figure? Does someone do swabs which are then tested and then you average them over the surface area?

Is this a standard method?

Are you taking into account degradation of the cytotoxic substances? Many do break down quite quickly due to the effects of UV and atmospheric oxygen amongst other things.

If the substances are that nasty and persistent why are they not being handled in a higher level of containment?  The really nasty ones are usually handled in a glove box which is them cleansed out using some sort of ‘witches brew’ which will neutralised most cytotoxic compounds.  All you have to deal with is a corrosive liquid but that is easier to handle than the toxic material.

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Self and Hasty on 24/05/2019(UTC)
Self and Hasty  
#7 Posted : 24 May 2019 11:40:31(UTC)
Rank: Forum user
Self and Hasty

Thanks all for your input,

In answer to some of your questions;

We use around 20 different cytotoxic drugs in cleanrooms of varying degrees of nastiness, to manufacture chemotherapy drugs for cancer patients.

The 0.47ng/cm2 is for a surface swab of the floor, the ALARA set by the testing company we used. I quizzed them on this and they said they don't really know either it's just based on their 'statistics' which wasn't helpful.

The swab testing is done by QC annually (which is clearly not frequently enough) after a clean, and it still found nearly twice what the testing company would find acceptable, unfortunately the QA Manager said, we've never had a reading out of spec before, so the SOP doesn't say what to do if it is out of spec! (I'm so glad I'm leaving!)

There would be some degredation by exposure to air and light in the cleanroom, dilution in the bucket and some neutralisation from the bleach, though all of this is unquantified at the moment and thats why I'm trying to find some infomation on dilution etc.

The substances are controlled reasonably well in the cleanrooms, they are only used in aeseptic grade A pharmacutical BSC's, but spills dont get reported/recorded properly and production tries to hide spillages.

I've checked through the MSDS's contacted the EA, contacted the water board, scanned through HSE, and I still can't find much on it and nothing specific enough to help.

There is no agreement with the water company to dispose of anything other than standard domestic waste, so this is added to the to do list.

Thanks again for your help and suggestions

A Kurdziel  
#8 Posted : 24 May 2019 12:58:22(UTC)
Rank: Super forum user
A Kurdziel

From the document- Guidance on the classification and assessment of waste

(1st edition 2015)-Technical Guidance WM3 which is used by the waste sector:

  • cytotoxic and cytostatic medicines have a code  18 01 08* and are described as ‘AH’ = Always treat as Hazardous
  • Cytotoxic drugs will have a HP( Hazard Phrase) of Acute Toxicity (HP 6, Carcinogenic (HP 7), Toxic for Reproduction (HP 10) or Mutagenic (HP 11).
stevedm  
#9 Posted : 25 May 2019 05:30:42(UTC)
Rank: Super forum user
stevedm

thanks 1 user thanked stevedm for this useful post.
Self and Hasty on 29/05/2019(UTC)
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