Upcoming Events:

NewAge Industries-AdvantaPure

Click here to check out the brand new ISPE Boston Area Chapter Blog!

Process Piping Documentation for Pharmaceutical and Biotech Applications

by Tim Paulding, GMP Systems Inc.     
February 2004

Introduction

Process piping systems are critical components of pharmaceutical and biotech development and manufacturing facilities, transporting raw materials, intermediate and final products, and utilities from one location or piece of equipment to another. Because process piping systems are often in contact with product materials, proper fabrication and installation, along with supporting documentation, are important considerations in the construction and operation of a pharmaceutical or biotech facility. This introductory article provides an overview of the type of documentation that should accompany the installation of a process piping system.

In order to fully satisfy the product quality requirements in the pharmaceutical and biotech industries, process piping systems must meet several requirements. First, the piping systems must adhere to the engineering design specified by the user group or owner. Second, the installation and documentation must be completed in a manner consistent with current Good Manufacturing Practices (cGMPs). Lastly, the piping must meet applicable sections of one or more ASME codes and standards (depending on the specific application):

  • Process Piping Code (B31.3-2002)
  • Boiler and Pressure Vessel Code
  • Standard for Bioprocessing Equipment (ASME BPE-2002)

The documentation necessary to meet these requirements is normally divided into four distinct categories, each covering a specific aspect of piping system installation and commissioning:

  • Piping Components
  • Joining Methods
  • Welders or Welding Operators
  • Examination and Testing

Each of these four categories is discussed below. In all cases, responsibility for complete and accurate documentation rests with the installer of the process piping system, generally the owner or a specialized installation contractor.

Piping Components

The piping installer must provide detailed documentation verifying that the piping system components (tubing, fittings, valves, etc.) meet the requirements established in the system design specification. At a minimum, this documentation consists of the following:

  • Submittals - detailed specifications describing each component with signatures indicating acceptance by the owner or owner's representative
  • Certificates of Compliance and/or Mill Test Reports - lot-specific documentation provided by the component manufacturer certifying that the components supplied meet the specifications contained in the submittals
  • Incoming Quality Control Reports - containing the results of incoming QC inspection performed by the installer or a third-party employed for this purpose

Joining Methods

The piping installer must provide complete documentation describing the joining methodology used in the assembly of a process piping system as described in applicable sections of the Process Piping Code and Section IX of the Boiler and Pressure Vessel Code.

As an example, the joining-method documentation for a purified water distribution system constructed of 316L stainless steel would provide a detailed description of the GTAW (Gas Tungsten Arc Welding) process, consisting of the following:

  • Welding Procedure Specifications (WPS) - defined in Section IX of the Boiler and Pressure Vessel Code, the WPS is a written document that provides direction to the welder (or welding operator in the case of automatic welding) for making production welds in accordance with Code requirements. The WPS fully describes the GTAW process used to assemble the system. Form QW-482 included in Appendix B of Section IX may be used as a model for the WPS.
  • Procedure Qualification Record (PQR) - the PQR certifies that test welds performed in accordance with the WPS meet Code requirements and summarizes the specific test results. Form QW-483, also found in Appendix B, may be used as a model for the PQR.
  • Weld Map - an isometric drawing showing the location and numerical identification of each weld used in the construction of a process piping system. Each weld, when completed, is labeled with the weld number indicated on the weld map, the date completed, and the welder/welding operator identification number or code.
  • Weld Log - the weld log contains critical data pertaining to each weld identified on the weld map, including the results of in-process examinations.
  • Weld Sample Coupons - actual test welds used to demonstrate weld quality at critical points during system installation. At a minimum, test welds are performed at the beginning of each shift, before and after "blind" welds, and whenever a significant change is made (replacement of electrode, purge gas, power source, etc.) that may affect weld quality.

Welders and Welding Operators

The piping installer is responsible for the performance of welders/ welding operators and must provide documentation establishing the individual welder/welding operator's ability to create welds in accordance with the WPS and Code requirements. This documentation consists of the following:

  • Welder/Welding Operator Performance Qualification (WPQ) - The WPQ documents the results of performance testing as required by Appendix B Section IX. Forms QW-484A and B included in Appendix B of Section IX may be used as models for the WPQ for welders and welding operators, respectively.
  • Identification of Welders and Welding Operators - Each qualified welder and welding operator must be assigned a unique number or code that is used to identify individual work.

Using the prior example of a purified water distribution system, inprocess testing would consist of visual examination of the external surface of all welds, borescopic examination of internal surface of selected welds, acceptance (or rejection) of each weld, any additional testing agreed upon by the owner and installer, and the completion of associated documentation. Process piping systems subject to more rigorous operating conditions may be subject to additional examination and testing requirements.

Once installation is complete, the installer completes a final hydrostatic or pneumatic leak-test to verify overall system integrity. The test must be performed and documented according Section 345 of the Process Piping Code.

Both in-process examination and leak testing are the responsibility of the installer and must be conducted and documented by qualified personnel according to written procedures. However, it is the owner's ultimate responsibility to verify that the required testing and examinations have been conducted and that the system, as installed, conforms to Code and to the requirements of the engineering design.

 

Page last updated: 5 March 2009