Safety concerns not blown out of proportion as APIs become more volatile, says Rembe

API and drugmaking facilities, along with many other industries, are constantly at risk of explosions which may injure employees as well as destroy batches of product. In the past few years, incidents have occurred at some of the biggest pharma firms, including Amgen​, while last week life sciences firm Life Technologies - acquired by Thermo Fisher Scientific last year - reported a “chemical reaction”​​ at a site in Eugene, Oregon.

Furthermore, some incidents are deadly such as explosions last year​ at a Teva API plant in Israel and another at its subsidiary Pliva Pharmaceuticals in Croatia, but injury and damage – and the associated costs to the company – can be avoided through proper facility planning, according to German safety and security firm Rembe.

“If you do the right job at the start in the planning and engineering stage, then you can avoid many issues,”​ Rembe spokesman Klaus Meichle told in-Pharmatechnologist.com at pharma processing show TechnoPharm last week in Nuremberg, Germany.

“It is very important that we are in the beginning of the engineering process involved and not at the end,”​ he said, adding “it will save a firm a lot of money if you involve protection explosion in the first steps,”​ and also fulfil many of the regulatory guidelines for explosion protection.

Two explosions at an Irish facility run by Corden Pharma in 2009​, for example, did not cause injury or environmental damage but the firm was still fined €7,000 ($10,300) and ordered to pay more than €6,000 for health and safety breaches.

“In Europe you have the ATEC standard which helps you define where you have the explosion zones,”​ he continued, adding there were similar regulations in the US and ASIA. “All in all you have to think about what you are making, then think what are your ignition sources and how to use special explosion equipment to prove quality of safety equipment and of safety standards.”​

However, the industry’s thinking around explosion protection has increased over the past few years according to Meichle, as powders used in drugmaking have become more volatile with higher quality and finer particle sizes.

“As APIs become more volatile and inflammable there is only going to be more interest in explosion protection,”​ he said.