Guest Column | January 14, 2013

Save Time And Money On Turn-Over Packages, Pre-Validation, And Factory Acceptance Testing

By Mark McGlynn, President, IPEC

Documentation developed, information collected, and labor expended to create a turn-over package (TOP) for a biopharm modular system represents a significant cost to any project. So much so, that when working with a client, we jokingly say “we sell documentation and you get the system for free.”  To properly validate a system, you have to make the investment in documentation, but you can realize significant labor and cost advantages when developing TOP documentation and pre-validating your modular system via Factory Acceptance Testing in a closed-shop environment.

Putting Together Your Turn-Over Package (TOP)

A significant amount of validation documentation is developed and assembled for each biopharm system. This consists of, but is not limited to, the following:

  • Calibration Certificates
  • Material Certificates
  • P&ID Schematics
  • Dimensional Assembly Drawings
  • Mechanical and Electrical Bills of Materials (BOMs)
  • Weld Log, Weld Map, Rejected Weld Log
  • Electrical Control Drawings
  • Incoming Material Inspection Reports
  • Boroscope Inspection Reports
  • IQ/OQ Check-Out Report
  • GAMP Documentation
  • Component Catalog Cut Sheets for all equipment
  • Passivation, Drain, and Riboflavin Test Reports

These vendor data requirements (VDRs) are established at the beginning of a project by the customer or an engineering firm hired by the customer. The above mentioned list represents the minimum level of documentation provided by the manufacturer to assist in system validation.

The costs associated with putting together this information, when building a system on-site exceeds the cost when building a modular system. The first reason is the task of assembling the weld documentation, which consists of material certificates, welding logs, weld maps, welding procedures, rejected weld logs, and many other pieces of information associated with the welding processes that are collected for the final TOP documentation. Collection of this information requires trained personnel consistently following standardized procedures to ensure all information is accurately captured. Doing this on-site is very difficult and more costly due to the many companies involved in providing goods and services on-site. There may be one company providing materials, other providing sanitary welders for the project, a different one hired to inspect the welds, and in many cases, a separate company hired to coordinate collection of all this information. With a modular system, the supplier provides these services, as well as develops fabrication and as-built drawings used to manufacture the system — with all costs associated bringing the drawings to an as-built status upon completion of fabrication, included in the price. Additional labor and expenses are required to field verify dimensional information and line slopes when building a system on-site.

Pre-Validation And Factory Acceptance Testing (FAT)

All modular systems go through extensive testing prior to shipment. These tests are pre-validation activities, which reduce the amount of time that is spent performing these same tests in the field. This doesn’t eliminate site acceptance testing (SAT) and final validation of the system, but does greatly reduce problems that may occur and the time it takes to test a system for the first time on-site. Internal IQ/OQ procedures developed by the manufacturer ensure that each component on the system is installed, operates correctly, and the part number matches what has been purchased for the application. Serial numbers of all the components are collected and documented. Line slopes are verified and wet testing of each instrument confirms if the calibration range for each instrument is correct. Riboflavin testing of tanks to ensure proper spray coverage, as well as low-point drain tests can also be performed.

Modular system manufacturers much prefer to correct any mistakes or make customer recommended modifications prior to shipment. Costs associated with correcting any mistakes are borne by the manufacturer, while customer requested changes are typically paid for by the customer. Regardless of the situation, the cost and time to correct or make changes prior to shipment is significantly less than when changes are made on-site.  Documentation of the changes is also seamless when collected in a closed shop environment versus trying to capture this information in the field with multiple parties involved. IPEC, as with many other modular system suppliers, has a dedicated documentation group that collects and assembles information for every system built.

These are just some of the advantages associated with TOP development and factory acceptance testing (FAT) of a modular system. In the final installment of this series, I will discuss how modular system construction allows a product to be quicker to market.

About The Author:

Mark McGlynn is president and owner of Integrated Process Engineers & Constructors Inc. (IPEC). IPEC was formed in 1996 and is a worldwide provider of modular process systems for the biotech, pharmaceutical, biofuel, food, beverage, and dairy industries. Mark formerly worked at Hartel Corp. (1976-1996) as their Director of Engineering.