Testing Guide for Pharmaceutical Equipment

Introduction

Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) are essential to ensure that your equipment was built to last. The FAT will help you visually guarantee your equipment meets the specifications of the purchase order (P.O.), or contract. With COVID-19 concerns, the onsite visits have become more of a challenge, but not impossible. Following safety protocols recommended by the CDC for in-person visits is the best way to keep your team and your equipment partners safe. Paul Mueller Company hosts have been trained and are continually updated on CDC guidelines and will take necessary steps to provide the safest environment for all parties. 

Next, these 10 steps of successful testing will ensure the product's reliability and provide necessary performance and operational function testing to ensure the equipment performs as designed and expected.  

Keys to Successful & Efficient Testing

Keep Your FAT Date

It is important for both the manufacturer and the customer to maintain a stable FAT date. Changes in time frames can cause problems with staffing schedules and preparedness. If the date needs to be changed, let the other party know as soon as possible.

A Good FAT Begins Before It Starts

Good vendors will ensure the equipment is tested before your arrival. Pre-testing can happen anytime, from weeks to days before the FAT. Your manufacturing partner should perform a pre-FAT test and run a full-capacity or Production Data Report (PDR) test. The PDR will test the unit’s capabilities and flow rates to ensure the equipment produces what it is expected to produce.

Be Aware of the Testing Procedure

Have a testing plan in mind to expedite the testing process and ensure safety for all personnel. Determine who will provide the test plan.  A detailed plan will outline your process's quality, reliability, and safety requirements. Review the FAT documents before the FAT so you know what to expect. Standard testing includes functional and safety testing, such as alarms and warnings, but additional customer-specific testing may exist. Incorporating this into the FAT documents in advance will greatly reduce the testing time.

Involve the Right Personnel

This is the time to interact with the craftsmen and craftswomen who work on all aspects of your equipment. Use their knowledge to your benefit. Recognize the different specifications of your equipment and become familiar with them at the FAT in order to be prepared when you have it fully set up at your operation. In other words, ask questions.

Assess Risks & Predict Problems

List any anticipated shortcomings for the machine you are testing. These could include past issues experienced and expected outcomes for each process phase. Make a list of solutions for these potential problems to quickly and seamlessly work through issues during testing. Running, even dry running, is very critical. Making changes to equipment during the FAT stage is much more cost-effective and efficient than making on-site modifications.

Carefully Check the Safety Features

Safety should be a top priority when dealing with new equipment at an unfamiliar site. Approach uncertain items and procedures cautiously and, when in doubt, ask manufacturing technicians questions or pause testing to ensure the procedures are performed safely. Inspect your equipment with safe, reliable production or processing in mind. The test plan should check the functionality of all safety components and emergency switches and look for areas that may cause later problems or put a worker in a dangerous position. You should have an understanding of how the equipment will be utilized at your specific workplace.

Make the Best Use of the Time Available

Ask your manufacturer partner to have hookups ready to go before starting.  If they can also lay out whatever equipment is needed for the next round of tests, the process will be much more productive.

Take Your Time

While the goal should always be efficiency, this concept includes more than just timeliness. Ensure that each test stage is carried out systematically and that nothing is skipped or overlooked. Never cut corners with factory testing to meet a deadline. You will ultimately pay the price for this in longer start-ups and lost productivity at the factory.

Be Flexible

Be prepared to change course during the FAT if problems arise.  Be prepared to come in early or stay late to finish the job, and expect your manufacturer partners to do the same.

FAT & SAT Both Exist for a Reason

The purpose of the Site Acceptance Test (SAT) when the equipment has made it to your facility is to determine how the machine works under the intended factory conditions. The manufacturer’s plant may not be equipped to test the machine at full capacity or with all product components included. Factory Acceptance Testing (FAT) at the manufacturer’s facility, therefore, will determine whether a piece of equipment can operate at the desired capacity without actually testing it at full capacity. Testing equipment for full-capacity production is reserved for SAT. It is best if all utilities are installed and ready for use. Placing a load on the equipment may be tuned and adjusted to respond to all on-site conditions, as needed.

FAT testing is intended to provide you with a thorough understanding of how your new equipment operates. Be sure to include equipment operators and maintenance personnel in the SAT procedure, so they may become familiar with the training. Additional on-site training may also be scheduled if it is not possible for everyone to attend the SAT.