TACT Talk

Bio-Pharmaceutical Validation Process Documentation

The Gift of Time: Robust Documentation Means Validation Process Savings

Robust documentation, or turnover packages, helps customers realize great time and money savings in their critical cleaning and validation process.

It starts with a well-organized Factory Acceptance Test, or FAT, which involves testing procedures conducted at the Sani-Matic facility that directly engage the customers. During several days of rigorous testing, systems are put through the motions simulating how they should perform once installed at the customer’s facility.

“We run a system through a detailed, pre-written test script with the customer,” Mark Espland, automation and documentation manager said.

The testing and verification approach includes the following:

  • Test instrument calibration log
  • Drawings and schematics verification
  • Equipment identification and design verification
  • Control system verification
  • Component operation verification
  • Human Machine Interface (HMI) verification
  • Recipe sequence verification, and much more

Taking time out of a schedule to test equipment is a very big investment for companies.

“We thoroughly test our customer’s equipment at our facilities before they even visit us for the FAT. It is a pre-FAT process that ensures the FAT is very productive when our customers are here,” said Espland.

He added, “Many of our pharmaceutical manufacturing customers plan to be in an FAT for a full work week, but our preparation often allows them to leave earlier than expected.”

Following a thorough FAT, and after addressing any punch list items, the equipment is set to be delivered to the customer’s site. This is where the IQ/OQ (Installation Qualification and Operation Qualification) documents play a key role.

The IQ/OQ documents are based on the FAT document, but include site-specific information. “A detailed IQ means there are extensive instructions on how to properly install the system rather than getting a lot of drawings and a complex piece of equipment and being left to figure it out,” said Chris McNulty, director of key accounts, bio-pharm. The OQ clearly specifies how to operate the system using the customer’s utilities. Clear instructions on installation and operation help save customers a lot of time.

Because Sani-Matic provides customers with robust and detailed test plans and operational documentation when turning over equipment, the customers leave the FAT with confidence they will be able to complete their validation process with fewer headaches and less time once the equipment is installed.

“Time savings is worth a lot,” stated McNulty. “Every day saved during the validation process can equal thousands of dollars in validation costs and get our customers into production more quickly.”

Detailed Documentation Ensures a Smooth Validation Process

Preparing the equipment and documentation for a smooth validation process is a critical component of the whole Sani-Matic package.

“Ultimately, we are not just selling our customers equipment. We are selling the accompanying documentation that makes it easy for them to integrate their equipment into their process,” he said.

In the end, customers receive an organized, tabbed, easy-to-reference binder (or sets of binders), as well as a digital version containing all vendor documents. “Customers really appreciate the thoroughness of the documents and how easy it is to navigate and access a very large amount of information,” said Fayan Merck, documentation specialist. “Making sure validation personnel can quickly locate material certificates, calibration certificates, weld documents, instrumentation information, drawings, etc. is critical.”

The turnover packages are continually improved using customer feedback as a catalyst for constant change.

“We are constantly using our customer feedback to improve our documentation process,” McNulty said. “We have several employees dedicated to writing and updating the documents for clarity; documentation specialists dedicated to preparing the packages for accuracy and ease of use; and employees dedicated to testing equipment. There is also a strong quality system in place for tracking materials to be received as specified with the proper documentation.”

These continuous improvement efforts work. A global provider of sterile solutions, and a Sani-Matic customer, requested a digital version of the full turnover package to give to their other vendors as an example of what they want to see.

Now that is cleaning confidence.

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