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#1
Start by
Ashok Johnson
10-01-2013 12:47 AM

biotech/pharmaceutical

What are the major differences between automation in oil & gas industry and that in biotech/pharmaceutical industry?
10-01-2013 03:30 AM
Top #2
Mustafa Al-mosawi
10-01-2013 03:30 AM
At the simplest level the automation differences lie not so much in the nature of the control equipment, but in the underlying nature of the processes being automated. Biotech/pharma are batch industries, and oil and gas are continuous. Biotech/pharma go through much more complex sequences and that are highly sensitive to control parameters, with relatively fast reactions, and before resulting in product when compared to the simplicity of a level an temperature control on a cracking tower, or even the simplicity of control and automation found in pipeline or gas storage.

Beyond that, you may just want to read up on academic journals and literature between the two, or even commercial material, and it's pretty quick to see that the two aren't speaking the same language even though - in theory - the matheatics is the same.
10-01-2013 05:46 AM
Top #3
Sandeep Nair
10-01-2013 05:46 AM
I agree with Mustafa's inputs. In addition to those, in most countries, automation in Pharma industries mandate adherence to FDA regulations. One critical FDA requisite is that database records and batch operation records in DCS must be digitally signed prior to being stored in DCS. Proper archiving of these records is also necessary for reference during regulatory audits. Besides, the control strategies and batch sequences must be made part of a Version Control System. The DCS must preferably have Recipe Management capabilities. All these features are available in Honeywell's Experion DCS.
10-01-2013 07:50 AM
Top #4
Mustafa Al-mosawi
10-01-2013 07:50 AM
Sandeep, you make a good point. FDA regulation CFR 21 part 11 requires not only digital signatures on any materials that are handed to the regulators, but full auditability on any records that can be changed, for example lab samples. This level of rigour is not required in oil/gas

These features are part of most major DCS systems now, as well as being featured through AutomationIT software from a variety of vendors. Can I ask Ashok, what is the nature of your inquiry?
10-01-2013 10:42 AM
Top #5
Cesar Zuñiga
10-01-2013 10:42 AM
In the Pharma industry you need to measure parameters such as PH, Conductivity, TOC that are not used on the oil & gas industry the rest of the parameters (pressure, level temperature) are similar but the control strategies and safety level are different in the oil & gas industry redudant systems are very common.
10-01-2013 01:24 PM
Top #6
Ashok Johnson
10-01-2013 01:24 PM
Hi Mustafa,
My intention was to know biotech/pharma industry a little better from industry experts as I have no experience in that industry other than theoretical knowledge.
Thanks a lot for all of your inputs.
10-01-2013 04:12 PM
Top #7
Mustafa Al-mosawi
10-01-2013 04:12 PM
Cesar do you find that there is more use of multi-variate control instead of reliance on simpler master-slave control or simpler control schemes?
10-01-2013 06:53 PM
Top #8
Alex Gerassimenko
10-01-2013 06:53 PM
I believe the key features of O&G industry is exploisive atmosphere (and all related issues, like IS circuits, hazardous areas classification etc) and as was told above continuous process. Unfortunately never worked with biotech/pharma before, and have no ideas whether there are any area to be classified as hazardous?
10-01-2013 09:50 PM
Top #9
Cesar Zuñiga
10-01-2013 09:50 PM
Alex:In the Pharma there are areas that can be classified as hazardous but they are not as common as they are in the O&G Industry.

Mustafa:On my particular experience the use of multi-variate control is more common.
10-02-2013 12:44 AM
Top #10
Vincent Cantwell
10-02-2013 12:44 AM
Hi Guys,
Bit of a general question this, as there are significant differences between the two types of industries much of which are too great to deal with in a few lines. As already mentioned there are differences in control strategies due to batch / continuous unit operations and there are huge validation and documentation issues in the Pharma world which if you've never worked in the business are always underestimated, (which is not surprising considering the FDA can shut down production and impose huge fines for serious malpractices).

Pharmaceutical is split between chemical based and biological based pharmaceutical products, (with a huge growth in the latter in recent years which is often referred to as bio-technology). With biopharma the process involves the growing of living cells, (which can take months to develop commercial viable quantities). Chemical based process share several similarities to O&G with hazardous areas present but do tend to be batch based processes, with glass lined reactors at their heart. In O&G you are usually trying to separate / purify components whereas in chemical based pharmaceutical the focus is on combining products or at least altering their chemical structure.

With both branches of pharmaceuticals the focus is on efficacy (how well a product does what it claims to do, after all it will be taken be someone in a weakened condition) and contamination.

Pharma plant designers have to focus not just on general process control and design but also on environmental control and potential sources of contamination which can involve significant HVAC controls, and work on product flow within the production building. In bio pharma you can be dealing with multiple skid build specialist equipment items which can present significant third party vendor and integration issues.

In O&G you're producing huge quantities of relatively low cost product but in pharmaceutical you can be producing tiny quantities of extremely expensive product.

Finally however, there are enough in common between the two, that if you enough core knowledge and experience of industrial automation you can adapt between the two, (may not get a management position in pharmaceuticals without pharma experience though).

Hope this helps...

PS: 21 CFR 211 is only applicable for "quality" based data that resides within an "electronic" record, i.e. the FDA doesn't mandate you to keep production or quality records electronically but expects that if you do, then these electronic records should have the same accuracy, traceability and transparency as a paper record. Demonstrating compliance with these requirements is a different and complex conversation..
10-02-2013 02:55 AM
Top #11
Manoj Domyan
10-02-2013 02:55 AM
Thanks, Vincent
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