What Comes in a Pharmaceutical Equipment Turnover Package (TOP)

Introduction

Turnover packages should contain complete documentation and instructions for purchasing pharmaceutical processing equipment. They can be your field guide as you delve into production. Make sure you are getting the complete information your company needs before it's delivered by checking off these seven items on your TOP:

Replacement Parts List

With new equipment, you shouldn't have to worry about replacing parts for quite some time, but a replacement parts list is necessary when that time comes. Ask if your vendor has an after-market online store to save you time later when searching for and ordering these specific parts.

Software/Electrical Files

Documents such as Electrical As-Builts, Instrument Manuals, PLC Application/Executable files, OIT Applications, and compiled files can be part of your TOP. Developmental software packages and other documentation are typically not given out. Confirm your expectations regarding software/electrical documentation with your vendor before shipment.

Instrumentation Documents

Cutsheets, manuals, and certs, oh my!

Various instrumentation documents can help you better understand your equipment during installation, usage, and maintenance. If applicable, You should receive cut sheets, spec sheets, operations manuals, and equipment certifications. Verify that the documents provided with your package are what you need and keep them on file for reference by everyone in your company who uses the equipment.

Original Documentation

It’s important to know which original documentation you are receiving. Some documents, such as welding records, are not given out as original records but as authorized copies. Others, such as your Factory Acceptance Testing (FAT) documents, should always be original. Ask your pharmaceutical equipment manufacturing partner to know exactly what version you are receiving.

Certification Documents to Validate Equipment

Regulatory agencies such as the US FDA (United States Food and Drug Administration) often need to ensure that systems are designed, installed, and maintained by all applicable requirements. Your pharmaceutical equipment partner should have extensive industry experience to provide you with the correct certified documents needed for the validation and start-up of your equipment.

Hard Copy vs. Electronic Copy

What format will your TOP come in? You may prefer the more tactile read that hard copy text can provide. It can be passed from hand to hand and always serves as a backup if electronic files are down. Or you may need the freedom to access and send the electronic copy on the move. If you can’t decide or want your TOP to be backed up in multiple forms, just ask for both.

When does the TOP Arrive - With or Without the Unit?

Confirm how your TOP will be delivered. Will it be shipped as a separate package? Will it arrive with your equipment? Will your startup crew bring it with them? Communicating with your manufacturing partner on this issue ahead of time will help you schedule the training window with your personnel before equipment implementation.

The more you know about your pharmaceutical equipment, the more efficiently you will run your operation. Take the time to ask questions about your TOP and avoid miscommunications and misaligned expectations. 

And remember, the education doesn't stop there. Paul Mueller Company offers a hands-on systems training course for our clean steam and pure water equipment to give customers even more thorough knowledge of equipment operation, troubleshooting if problems arise, and proper maintenance to prevent problems altogether.