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Mission-critical control at Parnell pharmaceuticals plant

A new pharmaceuticals laboratory and manufacturing facility incorporating state-of-the-art instrumentation and control technology poses exciting opportunities for process vendors, writes Sarah Falson.

Veterinary pharmaceuticals developer Parnell has launched a multi-million dollar, world-class manufacturing plant and laboratory in New South Wales to support its growing international business. The Alexandria laboratory and plant is equipped with some of the country’s most high-tech test, measurement and sensor equipment, helping the site develop highly-potent, sterile injectables for veterinary use.

Parnell’s Estroplan product — a reproductive hormone for cattle — will be manufactured at the site and sold to the lucrative European and United States markets, meaning the Alexandria manufacturing base needs to meet the demanding global pharmaceutical (both human and veterinary) regulations.

The company is currently in negotiations to sign a global co-marketing partner for its Zydax product which treats osteoarthritis in dogs and horses. The deal is expected to increase the company’s annual sales to more than $80 million over the next five years — making Parnell the fastest growing veterinary pharmaceuticals company in Australia, according to its developers.

According to Parnell CEO, Robert Joseph, the laboratory site is equipped with an extremely intelligent environmental conditioning system which is supported by a range of high-tech process control systems. But at only 30 per cent of the manufacturing facility’s overall capacity, Parnell will be looking to new technology providers to supply intelligent gear for the site’s forthcoming expansion.

“The pharmaceutical industry in Australia is a significant, multi-billion dollar industry. Historically dominated by subsidiaries of a number of multi-nationals, the entire pharmaceutical industry is worth around $10 billion,” Joseph told PACE.

According to Joseph, the Parnell operation itself expects to employ another 25 workers over the next year, with more opportunities as the facility’s contract manufacturing business expands.

“These facilities only get built in one size — and that size is big!” Joseph said. “We have a huge opportunity for contract manufacturing in the future, and we hope to move to a ‘24/7’ shift capability in time. This upgrade means a substantial requirement for quality testing equipment and environment control, along with new staff who are technically proficient.”

The 3,000 square-metre facility was officially opened by the Minister for Trade, the Honorable Simon Crean last month, and now stands as one of only a handful of plants in the world that is licensed to manufacture highly potent sterile injectables for sale in the lucrative European and United States markets.

The state-of-the-art plant meets the global Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) standards, and has been a significant investment for Parnell. It has the capacity to manufacture millions of doses of its Estroplan and Zyadax medications annually, and has been designed to cater to significant global expansion as well as contract manufacturing possibilities.

While a lot of the process control systems are already in place, the PLC, temperature, pressure, humidity and control equipment all have the ability to be up-scaled as Parnell requires.

“[Having high quality test and measurement equipment] is a cost ofentry in many respects,” said Joseph. “The SCADA system here is one of the most significant elements of our inspection and certification, that occurs via the FDA and TGA authorities. Sterile injectables need to be robust for their entire lifecycle. The testing and SCADA system — and eventually the newcontrols systems that will be introduced over time — are absolutely critical to the operation of the facility.”

Parnell made a “significant investment” in quality, analytical and research systems, Joseph said. “The technical elements implemented in the plant go right from the research to the manufacturing. It is very, very important to have reliable systems. The authorities shut you down if they don’t trust your systems!” he said.

According to Parnell quality director, Brett Lieurance, the company’s preferred suppliers for the New South Wales laboratory and manufacturing facility have so far been: Wonderware (HMI and historian); Rockwell Automation (PLC); HachUltra (particle counters); Vaisala (humidity instruments); Titan (pressure transmitters); and HP (servers and PCs).

Parnell has also used a group of third-party integrators including: Efficientia Solutions (HMI, historian, reports and project management); IC Solutions (PLC programming, panel building and power distribution); TJ Instruments (particle counters); Take Control Technical Services (validation); and Labtech (electrical/mechanical installation work).

Lieurance said that the process control installation also took into account the plant’s carbon footprint, and implemented measures not monitor the site’s emissions.

“We have put in place measures to control our carbon footprint in terms of variable speed drives, and soft starters for heavily electrical equipment. The lights that we use on-site are also maintained at a lower temperature with higher temperature periods over peak periods. Looking to the future, we could possibly put in monitoring systems for the SCADA system, allowing us to measure the use of our electricity and adjust it accordingly,” he said.

The Parnell site’s air conditioning unit is extremely robust, and offers handling capabilities to meet the sterile injectable facility which involves developing aseptically-prepared solutions.

“The air conditioning unit is a major component of the design and construction of the facility. The air conditioning was provided by Hamill Air Conditioning Control by Automated Logic and is all linked through to the SCADA system and the environmental controls,” Parnell CEO Joseph said.

According to Joseph, it is extremely difficult to lower a pharmaceutical plant’s electricity usage, due to the energy-intensive air conditioning and environmental conditioning systems in use.

“Unfortunately air conditioning systems are very intensive utilisers of electricity. In terms of environmental control, the air that comes out of this facility is a hell of a lot cleaner than the air that comes in. However, we have extensive environmental protections around our waste disposal, including what goes down the drain and what goes out into the air. We have very stringent controls over that,” he said.

The system’s basic architecture is based around logging the measured data from the instrumentation back to a central server. This server was provided by Microsoft and runs on a Microsoft SQL database. All the data being recorded is date- and time-stamped and logged in the database.

Wonderware’s Historian has been used to log the data into the database. The historian communicates with Rockwell Automation’s Allen Bradley PLCs, which collect the data from the instrumentation via ethernet. The historian also communicates with the particle monitors via ethernet.

There are two view nodes which use Wonderware’s Intouch HMI software to view the status of the system and display alarms. There is no control from this system except for placing the particle monitors off line, turning the vacuum pumps on and off and suspending the alarms while the rooms are cleaned.

The Wonderware HMI is visible from the plant room and the engineering room and is an essential for monitoring the clean environment in the airlock adjacent to the plant room, and shows this status at all times. It also monitors the status of: all the rooms; the alarms; communication to the PLC; and communication to the database.

Instrumentation on the Parnell plant’s water system and steam system are fed back into the Allen Bradley PLC, with alarms and events logged by the Wonderware historian.

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