Turn over packages should contain the complete documentation and instructions that come with your pharmaceutical processing equipment purchase. 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 7 items on your TOP:
1. 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 for 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.
2. Software/Electrical Files
Documents such as Electrical As-Builts, Instrument Manuals, PLC Application/Executable File, OIT Application and compiled files can be part of your TOP. Developmental software packages and other documentation are typically not given out. Confirm your expectations in regards to software/electrical documentation with your vendor prior to shipment.
Cutsheets, Manuals and Certs, oh my!
Various documents for instrumentation can help you understand your equipment better during installation, usage and maintenance. You should be receiving cutsheets, also known as spec sheets, operations manuals, and equipment certifications if applicable. Verify 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.
4. Original Documentation
It’s important to know which original documentation you are receiving. Some documents such as welding records are never given out as original records, but rather 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.
5. Certification Documents to Validate Equipment
Often regulatory agencies such as the US FDA (United States Food and Drug Administration) need to ensure that systems are designed, installed, and maintained in accordance with all applicable requirements. Your pharmaceutical equipment partner should have extensive industry experience to provide you with the correct certified documents needed for validation and start-up of your equipment.
6. Hard Copy vs. Electronic Copy
In what format will your TOP come? You may prefer the more tactile read that hard copy text can provide. It can be passed from hand to hand and always serve as a backup, if electronic files are down. Or you may need the freedom of accessing and sending the electronic copy on the move. If you can’t decide or want your TOP to be backed up in more than one form- just ask for both.
7. When does the TOP Arrive - With or Without the Unit?
Confirm how your TOP will be delivered to you. 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 prior to 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 pure steam and pure water equipment to give customers even more thorough knowledge on equipment operation, how to troubleshoot problems if they arise, and how to prevent problems all together with proper maintenance.