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LisaC  
#1 Posted : 13 November 2020 15:00:52(UTC)
Rank: New forum user
LisaC

Hi All, We are constructing a new facility with an already existing pharma company and one thing that is currently being researched is Spray dryers. I understand that these come with a fair few safety concerns however, as this is not something we have used before I wondered if anyone might be able to provide a bit of back ground info in how you got around the health and safety risks i.e. dust explosions, nitrogen gas handling etc! Alternatively...if anyone is currently working with them onsite, whether they would be interested in hosting a visit to go through their set ups etc. Obviously I understand that with the current covid situation the travelling side of things will be tricky but would be great to get something in the pipeline for next year. Thank you in advance.
paul.skyrme  
#2 Posted : 16 November 2020 16:19:14(UTC)
Rank: Super forum user
paul.skyrme

Hello LisaC,

I  guessing that this is going to be part of your manufacturing process.

Therefore (as we stand now), the equipment must be CE marked if stand alone.

If it forms part of a more complex assembly as in a production line which is linked, then the assembly, must, also be CE marked once completed.

Now the responsibility for this final CE marking is yours as the end-user, unless you place a contract with another company, to ensure this is done.

It's not an option, it's the law.  Even if you do the line design and implementation yourselves, you are still legally bound to CE mark the assembly.  This is specifically written into the law.

Additionally, there is PUWER Reg 10.

Nothing major is going to change in the next 12-13 months, perhaps 24 as the legislation and standards are UK based.  Once the "honeymoon" is over it is doubtful that the equipment standards (as in those published by the British Standards Institute) because the ideas in ISO, the IEC, and CEN/CENELEC is that the EN standards will deviate less and less from the ISO/IEC originals, and there will be more of these international standards.

The UK is NOT leaving ISO or the IEC.

OK, why have I stated all of this?

Because, the Essential Health and Safety Requirements (EHSR's) of the Supply of Machinery Safety Regulations (SMSR), by LAW preclude your hazards as described below.

The LAW says that they must not pose a dust explosion risk, end of story, no i's no buts' no options, it is an absolute requirement, not so far as reasonably practicable.

The same with the emissions of hazardous substances, whilst nitrogen is inert, it is an asphyxiant.

As far as the explosive release of pressure goes, then you have the EHSR's of the Pressure Equipment directive (UK version).

So your simple answer is that unless the equipment is poorly maintained and repaired, then the law says it must not pose these hazards.  Additionally, compliance with the law is implicit in any commercial contract, therefore the supplier must comply.

The trouble is they don't and under PUWER Reg 10, your organisation is going to be the one in the firing line.

If you don't have adequate safety engineering & I mean safety engineering, not generic H&S competence in your organisation, then I strongly suggest you contract it in and listen to your advisors.

thanks 1 user thanked paul.skyrme for this useful post.
Lisa Coleman on 17/11/2020(UTC)
Roundtuit  
#3 Posted : 16 November 2020 22:00:18(UTC)
Rank: Super forum user
Roundtuit

What support does the existing pharma company bring to the table?

Roundtuit  
#4 Posted : 16 November 2020 22:00:18(UTC)
Rank: Super forum user
Roundtuit

What support does the existing pharma company bring to the table?

stevedm  
#5 Posted : 17 November 2020 10:14:27(UTC)
Rank: Super forum user
stevedm

...non-pharma people google ....anyway....biggest threat here is the products that are being processed ATEx and the basis of safety for the dryer.. some products have extremely low MIE so your starting point is there which is why you want the full involvement of the client. There are very few of us who deal with pharma dusts and atex across Europe. The pharma company need to provide you with the assessment so that the system can be designed effectively. You may use various methods to do that suppression systems or nitrogen blanketing to ensure the system is safe whilst being processed. But just a note you need someone qualified in the area I.e. a chemical engineer or equivalent so competent to carry out the assessment. Calculations on the explosion prevention required will allow you to specify the equipment correctly. Pm me with some more specific it is a specialist subject.
thanks 1 user thanked stevedm for this useful post.
Lisa Coleman on 17/11/2020(UTC)
Lisa Coleman  
#6 Posted : 17 November 2020 11:49:45(UTC)
Rank: New forum user
Lisa Coleman

Hi,

Thank you for your replies - this is really helpful.

I fully appreciate that there is no 'reasonably practical' approach on this subject and as this is not something i have been involved with before, i thought i would throw it out in an IOSH forum. I also appreciate it is a very specialist subject so i am really grateful for your feedback!

We are currently in the process of just researching the equipment at the moment however, there is a large possibility that the company i work for will want to purchase one so i am researching to the end on this topic. To that end - i think i will have to contract out to a specialist to assist me with this one.

Thank you again everyone!

thanks 1 user thanked Lisa Coleman for this useful post.
peter gotch on 17/11/2020(UTC)
Lawlee45239  
#7 Posted : 23 November 2020 11:58:19(UTC)
Rank: Super forum user
Lawlee45239

Originally Posted by: LisaC Go to Quoted Post
Hi All, We are constructing a new facility with an already existing pharma company and one thing that is currently being researched is Spray dryers. I understand that these come with a fair few safety concerns however, as this is not something we have used before I wondered if anyone might be able to provide a bit of back ground info in how you got around the health and safety risks i.e. dust explosions, nitrogen gas handling etc! Alternatively...if anyone is currently working with them onsite, whether they would be interested in hosting a visit to go through their set ups etc. Obviously I understand that with the current covid situation the travelling side of things will be tricky but would be great to get something in the pipeline for next year. Thank you in advance.

Is the project at design stage?   As with any new build and associated equipment, there are a fair few regulations that need to be adhered to. The Client should have a clear picture of what is wanted, and the design team should be conducting the Design Risk Assessment/ HAZOPs to determine what needs to be in place as the works progress and for the end user. 

Depending on the stage you are at with the company the equipment is being purchased from they will be forthcoming with similar systems installed in a similar location adhereing to the local regulations. 

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