Maintaining high levels of quality and safety in pharmaceuticals manufacturing

Case Study: Alternative Engineering

Safety, Health & Environment (SHE) management is a fundamental responsibility of pharmaceuticals manufacturing.
Critical, life-saving products and their timely delivery to market rely on efficient processing and rigorous internal controls
to maintain a sterile environment and meet the standards set out by the TGA and management systems.

Executive Summary

This unique environment demands precise engineering processes, components and fast response times. Delays or breakdowns in the production process not only mean the potential loss of expensive and limited life-saving products, but large financial losses in lost productivity per hour. Unexpected failures cost some pharmaceutical manufacturers as much as $22,000 per minute.

Breakdowns and faulty processes also put products such as vaccines and medicines at risk. These highly sensitive products must be kept in a sterile environment where they don’t come in contact with other substances and are not exposed to certain temperatures. Unexpected faults or failures that expose or contaminate the product usually destroys the product which in itself can be worth hundreds of thousands of dollars.

Being subject to compliance with strict protocols and frequent audits by the Therapeutic Goods Administration (TGA), means ensuring processes follow the prescribed standards is a critical function. Manufacturing managers and engineers therefore rely heavily on precision engineering – first time, back-up expertise with an emphasis on problem-solving and process innovation and most critically resourcing that can respond immediately.

Two projects that highlight Alternative Engineering’s expertise in the pharmaceutical manufacturing environment centres on these deliverables.

Problem solving and innovation for Seqirus:

“I am pleased to inform you that the new 2215 size scroll Alternative Engineering redesigned and manufactured appears to be operating quite well. Since installing it we have not experienced any of the vial breakages that were previously affecting production. The vial transfer appears to be much smoother through the scroll allowing us to increase the speed of the scroll while still maintaining smooth vial transfer.” – James Stevens, Maintenance Support Engineer, Seqirus

Design of new production processes and supply of change parts for Glaxo Smith Kline (GSK):

“Alternative Engineering offer a significant added value as they design and draw up new processes and parts. We have documentation about how parts are created and how they work. They combine expertise and problem solving, reliability and on-time delivery, customer service and professionalism. These are all equally important to us.” – Graham Teece, Technical Team Leader, GSK

Requirements of outsourced engineering services to pharmaceutical manufacturers

Looking at the two projects in detail, we see common production occurrences where productivity may be lost and products put at risk thereby incurring hefty financial losses. Breakdowns or breakages also impact production lines which must be cleared of breakages and product residue which requires a careful clean-up and sterilisation process. This means downtime can be significant.

In the case of Seqirus, breakages on vial size 2215 were identified as a recurring issue. To address this issue, Alternative Engineering redesigned a new scroll technology that enabled smoother and faster vial transfer. This combination of lateral thinking and technical expertise not only created a seamless production process and resolution of the issue, production output was also improved.

For GSK, immediate response and ensuring that required parts fit and work the first time around is critical to smooth ongoing operations and scheduled maintenance routines. Sourcing parts from overseas can take longer than time allows and parts may not be straightforward or fit perfectly. Having the ability to engineer required parts on short notice and turnaround time is essential.

With the added pressure of frequent on-site inspections, faults in pharmaceutical manufacturing need to be dealt with straight away. Working with Alternative Engineering has helped both companies ensure that their production processes run smoothly and that they’re always prepared with reliable back-up for faults or breakdowns and on-site inspections.

Why reliability is paramount in pharmaceutical production environments

Manufacturing vaccines and medicines come with a fundamental responsibility in ensuring the environment in which these products are produced is safe, sterile and secure. Pharmaceutical manufacturing companies are audited several times in a year, to ensure that Good Manufacturing Practice (GMP) is being followed in the production of vaccines, medicines, and other therapeutic goods.

In a sterile, high output production environment, there is an urgent need for quick response times. This is because production process issues like glass vial breakages can cause a large impact on the continuity of production and on lost product.

Alternative Engineering understands that when their clients say things are urgent, they’re truly urgent. They have quick turnaround times and know the impact of breakdowns and downtimes not only in financial losses but also in market supply.

Alternative Engineering’s high quality engineering outcomes, together with their strong focus on reliability and responsiveness, provide pharmaceutical companies with the solutions they need to ensure compliance with strict protocols and that their critical products are produced in safe environments and delivered to market on time.

“One of the most important aspects of Alternative Engineering’s service is their quick response time. They are always switched on. I have faith in them to provide proactive solutions to get us out of a bind.” – Desmond Lobo, Production Manager, Seqirus

Alternative Engineering: Expertise and service you can rely on

Alternative Engineering is a leading Melbourne based engineering and manufacturing company that specialises in highoutput production environments with particular expertise in the Food & Beverage sector. With an impressive and growing client list, Alternative Engineering has built a reputation for exceptional customer-service, technical expertise, reliability and quality engineering outcomes.