Introduction
This procedure provides guidance for allowing Vendor’s Material of Construction (MOC) documentation, such as Certificates of Analysis (C of A) and other record documents, to be accepted as confirmation that a specified material has been used for new systems or components that come into direct contact with product. This guidance also provides considerations for MOC verification for Critical Components of Legacy Direct Impact Systems.
Documenting MOC for critical components where MOC may impact product quality is an expectation of the Commissioning and Qualification (C&Q) process. While MOC documentation is a good engineering practice during commissioning for all components of direct, indirect and no impact systems, the intent of this guidance is to provide specific guideline for product contact critical components of new and existing direct impact systems only.
Vendor-supplied documentation of material of construction is generally sufficient documented evidence for confirming that a specified material has been used in construction of the delivered system or component.
Recommendations & Rationale
Materials of Construction for critical components (e.g., product contact) in both manufacturing and utility systems should be suitable for their intended use, in that they should:
- Be compatible with the product and any cleaning, passivating, sanitising/sterilizing agents.
- Be smooth and cleanable (where required).
- Be resistant to temperature extremes (if applicable).
- Not have Particle release (be low or non-fibre shedding).
- Not contribute foreign substances to the product.
- Be non-absorptive.
- Meet surface finish levels, where required and specified.
Considerations for New Direct Impact Systems and their Critical Components
For new Direct Impact Systems and their related Critical Components (1), evidence of the suitability for intended use based on the materials of construction that come into direct contact with the product is obtained and confirmed during the Commissioning phase. The focus should be on components where the MOC could present a risk to product quality. Thus, the documentation criticality is higher where there is more risk that inappropriate alloys or materials may be present (such as custom-fabricated equipment where alloy, welding details or surface finish specifications are pertinent to protecting the product.)
The following are examples of inspection documentation for metallic and non-metallic materials that can be supplied to the purchaser directly from the manufacturer of the products, or through an intermediary or agent.
Example 1 -Vendor / Intermediary supplied Certificate of Conformance
Document in which the manufacturer (or an intermediary) declares that the items supplied are in compliance with the requirements of the purchase specification, without inclusion of specific inspection test results. This declaration of conformance is based on manufacturer-issued documentation.
Example 2 -Vendor / Intermediary supplied Materials Test Certification
Documents, issued by the manufacturer and based on specific inspection, in which it is declared that the items supplied are in compliance with the requirements of the order and in which test results are supplied.
The tests to be carried out and their limits are defined by the individual items’ specifications, official regulation(s) and/or the purchase order. The documentation issued by the manufacturer is confirmed by the manufacturer’s authorised inspection representative, independent of the manufacturing department.
The manufacturer is allowed to transfer onto this inspection certificate relevant test results obtained by specific inspection, provided that the manufacturer operates traceability procedures and can provide the corresponding inspection documents required.
Additional documentation to support confirmation of materials of construction, per example 2 above, may be required for new systems and components, if it is decided that there is an insufficient level of confidence in the vendor or their intermediary, based on the following considerations:
Lack of experience dealing with a particular vendor.
Vendor has a lack of experience in the pharmaceutical industry.
Level of uncertainty regarding the vendors’ quality systems and traceability of materials through production of the equipment or component. A Vendor Audit could be conducted in order to obtain confidence of the Vendor’s quality systems, if this is decided necessary. The audit report could incorporate a review of the vendor’s quality systems with respect to vendor-issued materials’ conformity documentation or certification.
There is a unique requirement for the product as specified in the purchase specifications; for example a specific surface roughness and finish (Ra values).
New/exotic materials, for example Hastelloy, are being purchased, with which the purchaser has no previous experience.
Example 3 -Vendor Supplied MOC Documentation for Standard/Off-the-Shelf Components:
For components that are standard products (such as pumps, instrumentation, and off-the-shelf tanks and mixers), it is acceptable for standard vendor documentation to indicate the MOC. This documentation may include standard shop/vendor drawings, manuals, or as-purchased submittals.
In this case it is considered industry practice that such documentation accurately represents the materials supplied, as long as the purchaser has confidence that the vendor is reliable and qualified, based on prior experience.
The above 3 examples provide the typical range of documented evidence of suitability for intended use for materials of construction for new direct impact systems and their associated critical components. The following considerations can be used to evaluate which format to use for specific applications:
Direct site experience with a particular vendor, or shared knowledge of vendors with other similar sites.
Level of Vendor experience within the pharmaceutical industry.
A vendor audit has been previously conducted on the manufacturer or intermediary.
The equipment / component purchased is standardised, or “off the shelf”.
Risk of impact to product quality due to the MOC of the component (higher risk = greater documentation requirement) Agreement on the required level of documentation for the materials of construction (MOC) needed to be supplied by the manufacturer (or their intermediary), should be reached early in the Design/Procurement phase for systems and components being purchased and built into the purchase specifications.
This will assure proper documentation is available for review during the commissioning phase.
The following information is intended to identify the stages where MOC certification is addressed for new systems and components and recommendations for each stage.
Phases of MOC Documentation Development for New Systems and Components Conceptual Design Phase.
During this phase, the User Requirements and Specifications (URS) may be developed, depending upon the type of system. Systems’ materials of construction requirements may be discussed and documented within a URS although this is not typical.
Preliminary Design:
During preliminary design, System Level Impact Assessments (SLIA) are conducted, determining whether the system is direct, indirect or no-impact. Purchase specifications are developed during Preliminary (and also Detailed) Design, and these document the MOC of each component, along with required vendor supplied documentation.
Detailed Design Phase:
At this stage of the process, Component Level Impact Assessments (CLIA) are conducted. CLIAs will identify components that have direct product contact and Commissioning Plans are then developed which will include critical and non-critical components requiring MOC verification.
The System Level Commissioning Plan also indicates which Commissioning Check-lists are to be completed; for example “Receipt Verification”, and documents when they will be completed; i.e.: during Factory Acceptance Testing or during on-site testing. The check-lists incorporate references to adequate methods of material of construction verification for both critical and non-critical components and equipment.
Procurement Phase:
During procurement, documentation requirements, vendor-based commissioning requirements, and equipment and material specifications, are included in purchase orders and contracts. Vendor and Contractor pre-Qualification activities also take place during this phase.
Construction and Commissioning Phase:
Material receiving and associated inspections, including relevant documentation such as MOC verification, are carried out during this phase, as specified in the System Level Commissioning Plan.
Qualification Phase:
The IQ section of the Qualification Phase, confirms that the commissioning activities are complete, including the verification of materials of construction for direct impact systems and their critical components.
Considerations for MOC Verification for Direct Impact Systems and their Critical Components
If the material of construction (MOC) of a direct-impact system and/or related product-contact critical component is required, but is not known, there are a number of different approaches which can be used to determine the MOC. The following approaches are recommended for verification of MOCs for direct-impact systems and related critical components.
Assessment of Documentation
The level of effort justified to ascertain and document MOC for legacy system components should be related to the risk to product quality represented by the components. For example, metallic piping of nearly any specification is suitable for handling many solvents used in pharmaceutical manufacture. In some cases, therefore it may be unjustified to ascertain the specific MOC for such a system, as the risk to product quality is low.
It is often possible to verify an unknown system or component MOC by collection and review of supporting documentation. This is the first choice option that should be pursued where possible. Through assessment of existing documentation related to the design, purchase and/or maintenance of the system or component, evidence of the material used in construction can usually be found. The compatibility of the system or component with materials used during processing can then be evaluated to confirm suitability for intended use. The following documentation can be examined to provide evidence of the material of construction of a system or component:
Purchase ledgers/orders – Procurement records often include model, serial number and material of construction information. This information can be cross-referenced to a system or component by way of the Engineering Project number of the original installation indicated on the Purchase Order system.
Vendor-supplied Functional or Design Specifications – Existing Vendor-supplied FS or DS documentation can provide a source of information to support MOC verification.
Vendor/Contractor P&ID’s, pipe-work Isometrics – Engineering records created during the project, such as drawings approved for construction may contain information regarding the MOCs.
Maintenance records -Reviewing historical maintenance records can provide supporting evidence, particularly by way of replaced parts or repaired equipment or pipe-work.
Equipment or Component User Manuals -Reviewing available equipment and user manuals can sometimes provide information to support MOC verification.
Existing Commissioning and/or Qualification Documentation – A review of existing commissioning and / or qualification documentation, if available, can also be used to support MOC verification. From a review of the above documentation and any supporting information that may be obtained directly from suppliers or vendors, the MOC for legacy direct-impact systems and related critical components may be able to be determined.
Field Verification methods for Determining Material of Construction
If obtaining the MOC of a legacy system or component is not possible by reviewing existing documentation, and it has been determined that further investigation is justified based on product risk from MOC, then the following method may be used to verify the MOC.
Identification Overview – Many methods can be used to identify an unknown metallic or non-metallic material. Destructive testing is not recommended or needed as a method of identification of material of construction used in legacy direct impact systems and related critical components. For enclosed piping and equipment systems, there is no expectation to disassemble or remove the covering materials of piping and equipment in order to visually inspect materials.
There are usually sufficient exposed materials in order to be able to adequately determine material of construction following the visual inspection methodology detailed below.
Visual Inspection of Surface Appearance (Metallic materials) – Sometimes it is possible to identify metals by a visual inspection of their surface appearance. Identification can often be easily conducted by inspecting the pipe-work or component for specific information such as:
Stamped markings on pipe-work or equipment, indicating material type or recognized manufacturing code and / or standard.
Valve or equipment identification plates Coloration of metals can sometimes provide a means of identification, as can manufacture markings left on the outside surface of the metal. A surface examination does not always provide enough information for identification but may give enough information to place the metal into a class. The colour of the metal and the distinctive marks left from manufacturing may help in determining the identity of the metal, with examples below:
- Cast and malleable iron usually shows evidence of the sand mould.
- Low-carbon steel often shows forging marks whereas high-carbon steel shows either forging or rolling marks.
Another aspect to consider in appearance is the type of welds and joints that are used, particularly in pipe-work systems:
Carbon-steel pipe-work associated with API production equipment is usually lined to prevent corrosion. In this case, joints between pipe-work sections are usually flanged, as the lining material generally can not be welded.
Stainless Steel and Hastelloy pipe-work is usually welded and Copper pipe-work usually utilizes copper compression fittings or soldered joints.
It is important to note that while classification of a metal may be determined, it would not be expected that specific alloys within metal classes (e.g. 304, 316L Stainless Steel) could beidentified using the described visual identification methods. It is recommended that if the metal class has been determined via visual inspection, that it be documented along with the justification for the material’s suitability for current use.
This may be particularly important for cases where new processes are introduced into existing systems and the new process has specific product contact material requirements. If determination of alloys within metal classes is required, there are technologies (e.g. Niton analyzers) currently available for verifying grades of metallic materials.
Visual Inspection of Surface Appearance -Non-Metallic materials Glassware and Plastic pipe-work is usually identified by external etching or marking, indicating the material of construction. In instances where material etching or marking is not readily visible or available other marks of identification, such as manufacturers’ name, product serial codes etc., may be used to assist with MOC determination.
Gasket materials used in direct impact systems are often food-grade Rubber, EPDM, PTFE, PFE or PTFE encapsulated Viton. These may be identified by reviewing available documentation and the Planned/Preventative Maintenance program to determine if the MOC of identical replacement parts can be obtained. Visual inspection of the gasket material may also provide an indication of its MOC.
In cases where field inspection of materials of construction is conducted for existing systems and components, the results of the review should be documented along with justification for the material’s suitability for intended use.
Glossary
Vendor – The Vendor, as referred to within this document, can be the direct manufacturer of the products being purchased, or an intermediary, as indicated below.
Intermediary – An Organisation which is supplied with products by the manufacturer and which then in turn supplies them to another company without further processing and without changing the properties specified in the purchase order and referenced product specification.
Non-specific inspection
Inspection carried out by the manufacturer in accordance with their own procedures to assess whether or not products defined by the same product specification and made by the same manufacturing process are in compliance with the requirements of the order.
Specific inspection
Inspection carried out before delivery according to product specification. Inspection of the products to be supplied, or of test units of the products, to verify that they comply with the purchase order.