Site Acceptance Tests (SATs) are the main event in the delivery of automation to the pharma manufacturing world.
SATs are the final trial, the culmination of all that work and effort; solid, documented, definitive and unambiguous proof that the automation system functions exactly in accordance with the customer’s specification. All control valves open and close at the right moment, heating systems maintain their desired set points within preset thresholds, pumps and flow rates are properly controlled and monitored, and finally, all critical data and alarms, aka GMP data, are properly collected, stored and made available to the manufacturing operators to ensure that products are being produced properly and consistently.
When the pandemic hit, many projects around the world were put on hold. It was no longer possible to safely travel to facilities and perform SATs in person. Yet many of these projects were critical for biopharma and pharmaceutical companies. Integrators had to find a way to remotely implement and document projects with the same certainty, confidence and thoroughness expected in a normal SAT.
And with the rise in cybersecurity threats brought on by increased remote work, an abundance of precaution needed to be taken to avoid the possibility of interference from malware, software viruses or other cyber interference. Furthermore, the documentation and formal signatures signifying acceptance of each process test by multiple parties located in different states or continents had to be arranged.
A case study in remote SAT
Here’s how the Superior Controls automation team managed a recent remote SAT, coincidentally for a project based in Wuhan, China:
The team had three computer screens set up in their home offices. One screen displayed the formal written 80-page Sequence of Operations and 48-page Site Acceptance Test. These documents had been downloaded to DocuSign and were also being simultaneously reviewed by the customer in China, the engineering firm in Pennsylvania and the consulting firm in Boston. DocuSign provides software that enables companies to manage and sign electronic agreements that can be stored in the cloud and signed by multiple parties in multiple locations. As each test in China was performed and the correct results noted, all four witnessing parties signed and dated their documents.
The second computer used a ruggedly secure Virtual Private Network (VPN) to communicate directly with the primary operator interface in the customer’s control room. This computer replicated and displayed everything the onsite customer could see: graphics, recipes, events, alarms, the state of batch reactors, and the state of all instrumentation and sensors in the facility.
As each test was performed at the biotech facility, all four parties — customer, consultant, engineering firm and Superior Controls — could see what the automation systems said was happening in the factory.
The third computer was connected to a portable camera held and guided by an onsite manufacturing technician during the entire acceptance test. This computer used Microsoft Teams to enable all connected parties to see and talk with each other during the testing. With the camera continuously active, all parties were able to see the positions of valves, the motion of pumps, and read the pressure, temperature and flow rates from the local instrumentation and sensors to confirm that the readings matched the computer-generated operator display readings.
In two weeks, the customer, consultant, engineer and automation systems integrator — all residing in various locations around the world — successfully tested and established that this new manufacturing facility worked properly. Furthermore, they were able to provide the customer with the signed legal documentation that the FDA, and most governing bodies for therapeutics, accept as proof that the system was tested properly.
The pandemic has certainly changed our lives temporarily in many negative ways. But perhaps, there will be some permanent benefits coming from this misfortune.
Superior Controls engineers have already implemented multiple successful remote SATs for chemical, food and beverage, and biotech facilities throughout the world. This may be a trend that sticks around even after the dust settles.