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Process Hazard Review (PHR) for the pharms industry

Ensuring compliance with COMAH regulations for a top tier site.

The Roche UK Ltd site in Dalry, Ayrshire, produces vitamin A, B1 and B5 as well as being the largest producer of vitamin C worldwide.

Due to the storage of toxic substances, including sodium cyanide and phosphorous oxy-chloride, it has been classified a ‘top tier’ establishment under the Control of Major Accident Hazards (COMAH) Regulations.

Services provided

ABB Consulting was initially contacted to carry out consequence assessment modelling of a number of potential major accident hazards. Once this initial report was completed, work began on risk identification for the PHR. This then formed the basis of the safety report to satisfy COMAH Regulations. At this stage Roche had approximately 10 months to complete a Safety Report to meet their deadline.

Using state-of-the-art computer modelling packages, ABB specialists assessed the extent and severity of the identified accident scenarios to determine whether they were classified as ‘major accidents’. 

An ABB process safety specialist worked alongside Roche to develop a methodology for carrying out COMAH risk assessments. This had to demonstrate that a rigorous methodology had been followed and needed to be consistent with existing Roche procedures for process safety studies. 

Having jointly developed a major accident risk analysis methodology a plant was selected for a pilot study led by ABB. This was a multi-stage batch pharmaceutical intermediate plant with 6 process steps including high pressure hydrogenation.

The Roche specialist was then able to roll out the methodology across the site to cover all the plants handling dangerous substances. 

Main data

Customer:  Roche UK Ltd
Site:  Dalry, North Ayrshire
Customer need:  To comply with COMAH regulations
Scope:  Provide a tailored PHR
Application:  Pharmaceuticals
Customer benefits:
Successful COMAH submission
PHR methodology to meet company guidance
Cost effective
Commissioning year: 2012