Automated Parts Washer Factory Acceptance Test
It is a common practice in the pharmaceutical and biopharmaceutical industries to execute a factory acceptance test (FAT) for equipment involved with various drug manufacturing processes. The FAT is a project milestone in purchasing good manufacturing practice–compliant equipment.
User requirement specifications (URS), functional specifications (FS), and design specifications (DS) are all incorporated into the equipment design and manufacture, as shown in Figure 1. The FAT is performed in production-like conditions at the manufacturer’s site, where testing equipment, utilities, and trained personnel are available to ensure that the equipment functions as designed. It is also easier and less expensive to correct issues or implement design changes at the manufacturer’s facility. A well-planned and well-executed FAT can lead to an easy transition to site acceptance testing (SAT), qualification,* and continual monitoring of the parts washer after delivery. 1, 2, 3, 4
Based on our decades of experience, this article presents best practices and critical items to avoid when planning for and executing an FAT for an automated parts washer. We also include a case study to illustrate the advantages of carrying out an FAT.
Documentation related to the equipment and the project can generally be provided in the manufacturer’s format as long as the manufacturer meets some basic criteria:5
- Having an acceptable quality system in place (ideally approved by a third party)
- Demonstrating the necessary technical capabilities and expertise
- Following good engineering practices
- Having approval from a subject matter expert (SME) and quality personnel, at a minimum
Control system documentation is normally expected to follow GAMP® 5 Guidelines . The more complete the FAT documentation, the easier it is to execute SAT, IQ, OQ, and PQ activities.
Project documentation is divided into two categories: predelivery and postdelivery.
* Instrument qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
|Sump temperature transmitter and non-recirculated final rinse temperature transmitter and exhaust temperature transmitter||Transmitter calibration has been performed according to instruction 920-514-
029 rev. ___________
|Pump outlet pressure transmitter||Pressure transmitter calibration has been performed according to instruction
920-514-037 rev. ___________
|Conductivity analyzer calibration||M300 analog outputs channels calibration has been performed according to
instruction 920-514-031 rev. ___________
|Conductivity sensor calibration||Conductivity sensor calibration has been performed according to instruction
920-514-034 rev. ___________
|770 MAX analyzer and 500 TOC sensor||770 MAX analyzer and 500 TOC sensor have been set according to instruction
|777 MAX TOC analog output calibration||777 MAX TOC analog output calibration has been calibrated as per 920-514-163
- 1. Van Houtte, O., P. Lopolito, and M. Dion. “Cleaning Validation Considerations for Automated Washing Systems.” Pharmaceutical Engineering 37, no. 2 (March 2017): 48–54.
- 2. US Food and Drug Administration. Guidance for Industry. “Process Validation: General Principles and Practices.” January 2011. http://www.fda.gov/downloads/Drugs/...Guidances/UCM070336.pdf
Postdelivery documentation, submitted to the end user after the FAT and any corrective follow-up actions are completed, is usually provided in paper or electronic format or both. Typical content includes:
- Operator/user manual
- Manufacturing and qualification documentation
- General arrangement drawings
- Rack and accessories drawings, if applicable
- Welding procedure specifications
- Procedure qualification report
- Heat number certificates
- Surface finish report
- Welding map drawings
- Welding logs
- Material certificates
- HEPA filter certificates
- Chemical delivery system specifications, if separate
- Control system validation documentation
- Software history
- Hardware design specifications
- Software design specifications
- Software module specifications
- Software module test specifications
- Software module test report
- System acceptance testing (software test documentation)
- System acceptance test report FAT protocol
Predelivery documentation is submitted to the end user before manufacture to ensure that both manufacturer and end user have a common understanding of all requested equipment features, documentation, testing requirements, delivery time, etc. It is often divided into a written order-confirmation letter and submittal package. “Certified for construction” documents and drawings are sent for approval by the end user once the design of the equipment is complete. Standard submittal packages include the following:
- Transmittal letter
- Drawings showing the layout of the equipment, utilities, and installation requirements
- Process and instrument diagrams (P&ID)
- Recommended spare parts list
- General arrangement drawing showing the layout and location of the major components
- Wiring/electrical diagrams
- Functional specifications
- Project schedule
- FAT protocol (sometimes sent with the “certified for construction” or “issued for correction” package only)
The overall project schedule should reflect the 4–6 weeks that manufacturers typically need to develop the preliminary submittal package, and the 2–3 weeks that end users need to approve it.
Upon approval, the washer manufacturer implements end-user comments, if any, and provides updated certified for construction drawings. Delays in issuing or approving these documents can have a negative impact on the unit lead time. Requests for alterations or modifications may also affect pricing and/or delivery time.
Factory Acceptance Test
The FAT, an integral part of the equipment qualification program, is designed to challenge the unit to ensure that it functions as intended. The equipment is tested in conditions as close to real life as possible, using sophisticated bays that are capable of duplicating virtually any site conditions, including electrical configurations, utility supplies, and calibrated measurement devices.
The FAT also confirms that the equipment is manufactured according to the approved design drawings, technical specifications, and end-user purchase order. A typical FAT may require 2–3 days of onsite attendance by end user representatives. The number of representatives may vary, depending on end user preference and objectives, but will generally include an SME from engineering and validation. Both manufacturer and end user understand that the unit documentation may need to be updated after the FAT and that final documentation will be issued after the unit is shipped.
FAT documentation contains elements common to standard operating procedures (SOPs) and other qualification documents, such as introduction, purpose, scope, responsibilities, overview, deviations, change control, corrections, test procedures, and results. FAT documentation should also include software version identification, P&ID, weld inspection checks, instrument checks, alarm verification, and coverage testing, if applicable (Figure 2). Finally, the FAT documentation is assigned a document number with the equipment number or serial number listed, as well as the document revision number.
Equipment Configuration Verification
This process confirms the installation of all unit options purchased by the end user. It is typically conducted via a P&ID walkdown, where all subsystems are depicted and explained, and main washer functionalities are identified. This is easily completed with one operator reading the P&ID and a second operator verifying that the drawing corresponds to the as-built configuration. Any deviations should be noted by redlining the P&ID and initialing and dating the edits. Once completed, both operators should initial and date the P&ID and personnel FAT record sheet. Figure 3 shows a typical P&ID of an automated washer.
Next, operators must verify that all the documentation purchased by the end user has been supplied. Standard documentation normally comprises component booklets or cut sheets for nonproprietary parts such as valves, sensors, temperature transmitters, etc.; control system documents; manufacturing documents; and other documents such as user manuals, installation checklists, spare parts lists, and preventive maintenance schedules. Component booklets and control system documents should align with the verified P&ID drawing. The documentation title and revision number, once verified, are listed in the FAT documentation and a hard copy or electronic copy is filed. It is also usually possible to purchase extended documentation packages containing more detailed information.
|Communication Has Been Lost with Customer SCADA System||Acceptance Criteria||Pass/Fail||Initials/Date|
While washer is idling (no cycle in process), disconnect the customer system cable and wait for the time set in the Communication Lost Alarm Delay field, in miscellaneous values.
Alarm is generated.
Once acknowledged, alarm is not monitored again until communication has been reestablished and lost again.
Accessories and Racks
Because loading racks and accessories are essential for proper washer operation, it is critical to confirm that all the necessary accessories have been supplied. These include baskets, spindle headers, clips, and other items. Any drawings of the racks and accessories should be verified and documented with the revision number in the FAT documentation. A list of replacement parts should also be included. Any changes to the rack or accessory drawings should be documented as part of the FAT.
If end user racks are not available during the FAT for some reason, manufacturers may use test racks to perform wash cycles. Ideally, accessories should be ordered at the same time as the washers themselves; over the years, however, we have observed that washing equipment is often purchased prior to defining load configurations; this explains why dedicated end user racks are typically ordered at a later stage in the project. If the accessories arrive after the FAT is closed, then the SAT or qualification documents can be amended and applicable sections verified. If the accessories are elaborate, then a separate FAT can be scheduled to verify the design and performance of the accessories prior to shipment.
Factory Setup Verification
Factory setup verification should be a review of software, electrical inputs, electrical outputs, instrumentation calibration/adjustment, and alarm/message testing.
Software: Demonstrate that the unit’s software has been configured according to the options purchased. We recommend that the end user save a copy of the software version prior to starting the FAT execution and then again after completion of the FAT.
Electrical inputs: Verify input signals’ electrical continuity by activating the input and confirming the response on the control display.
Electrical outputs: Verify output signals’ electrical continuity by activating the appropriate output on the control touch pad and confi¬rming the response of the output device.
Instrument calibration/adjustment: Verify that all instrumentation has been calibrated or set by the automated parts washer supplier or the instrument manufacturer. To demonstrate this properly, verify that each instrument procedure has been completed and the results documented as shown in Table A.
Alarm/message testing: Demonstrate the unit’s proper response when alarm conditions occur. The condition that generates the alarm is simulated and verified on the operator interface panel. During the alarm and message tests, it is important to document the procedure to activate the alarm so it can be repeated during the SAT or OQ protocols, if necessary. It is also important to note any operator or equipment safety risks that may occur when a specific alarm or message is triggered. Alarms triggered through activation of code or software edits should be noted. Refer to Table B for a typical alarm test procedure.
A cycle test performs a standard cycle to demonstrate the washer’s proper operation sequence (prewash, wash, rinse). Each operational test should be repeated for each programmed cycle. If no specific cycles have been defined prior to the FAT testing, then run a standard test cycle, which includes typical concentrations, temperature, times, and final rinse water pH and/or conductivity to verify that each phase within the cycle is operational. Refer to Table C for a typical operational test procedure.
Some type of performance testing at the factory is highly recommended, as it may significantly reduce the time required to complete PQ at the user site. These tests should ideally be performed using actual parts provided by the end user and the specific loading accessories that were ordered. When parts cannot be made available for the FAT, or if accessories are not available, representative components and accessories can be used. Two broad categories of performance tests can be completed during FAT: coverage and cleaning. These tests normally include a protocol and a report.
|Initiate a light cycle|
|Prewash 1 treatment|
|Prewash 1 filling||Sump fills with PORT 1||Pass/Fail|
|Prewash 1 recirculation||Recirculation time is 1:00 (MM:SS)||Pass/Fail|
|Prewash 1 drain||Water is drained||Pass/Fail|
|Wash 1 treatment|
|Wash 1 filling||Sump fills with PORT 1||Pass/Fail|
|Wash 1 heating||Water is heated to 150.0°F (65.5°C)||Pass/Fail|
|Wash 1 preparing injection||“Preparing injection” is displayed for 10 s||Pass/Fail|
|Wash 1 chemical injection||Chemical pump #1 is energized for 5 s||Pass/Fail|
|Wash 1 recirculation||Recirculation time is 4:00 (MM:SS)||Pass/Fail|
|Wash 1 drain phase||Water is drained||Pass/Fail|
|Rinse 1 treatment|
Coverage tests use a riboflavin solution as soil. The solution is sprayed inside and outside the components that are to be cleaned; it can be dried or not. The components are then placed in the recommended accessory and processed in the washer using a rinse cycle. Once the cycle is completed, the components are inspected using an ultraviolet light. Any areas not properly covered by the spray system will be easily detected.
Cleaning tests can be performed using end user–provided parts and soil(s). The parts to be cleaned are coated with the provided soil(s), then placed in the recommended accessories and processed in the washer using a full wash cycle. The specific load pattern should be considered and indicated in the test conditions as well as the dirty hold time for the soil. The clean parts can then be inspected by the end user and, if needed, cycles and/or accessories can be modified to ensure satisfactory results. One of the main advantages of performing this test during the FAT is that the washer and/or accessories can be modified much more easily at the factory than they can at the final location.
Because sending soils is not always possible or practical, a third alternative may be considered: Many cleaning agent suppliers can perform cleaning tests to support cleaning agent selection and cleaning parameter development. Coupons, or parts coated with the soil(s) to be cleaned, can be sent to these suppliers for analysis. This process should ideally be performed in parallel with the development of the URS, FS, and DS of the automated parts washer design. Such an analysis, when combined with a coverage test performed during the FAT, provides a strong rationale that supports the selection of the cleaning agents, process parameters, and accessories, greatly reducing the risks of “bad surprises” during the PQ stage.
Performance testing at the factory may significantly reduce the time required to complete PQ at the user site.
|Visually clean||The cleanliness test is confirmed using large (typically 3 inch × 6 inch) stainless steel coupons. After the cleaning trial has been completed, the coupon is rinsed with tap water for 10 seconds and observed for cleanliness. A coupon is considered visually clean if no residue of the sample or detergent is visible on either side of the coupon.|
|Water-break free||A visually clean coupon is rinsed with deionized water and tested for water-breaks. The coupon surface is coated with deionized water for 10 seconds while at vertical orientation and the surface is examined as the film of water drains. If the surface is clean, the water will form a thin continuous film that uniformly coats the surface. This film will persist for as long as 30–60 seconds.|
|Pre- and post-cleaning
|A visually clean and water-break-free coupon is air-dried at ambient temperature and then weighed on an analytical balance to determine its post-cleaning weight. The post-clean weight is compared with the weight of the dry clean coupon before coating. A large coupon is considered 100% clean by weight if its pre- and post-cleaning weights are within than 0.1 mg of each other. The coated coupon surface is approximately 100 cm2 for wet samples and approximately 200 cm2 for dry samples. The coated surface and sensitivity of the balance corresponds to < 0.5 g/cm2 or 1 g/cm2, assuming a uniform distribution.|
Case Study: Coverage And Cleaning Tests
In this case study, the end user is a global registered FDA cosmetics company with manufacturing facilities in several countries. The company purchased an automated parts washer to process filling line components, move away from manual washing, increase throughput, reduce manual handling of chemicals due to safety issues, and improve general consistency in washing. A laboratory evaluation was carried out for a range of viscous skincare products.
The goal of the laboratory evaluation was to determine optimal cleaning parameters to remove the following products from stainless steel and polyester tanks and equipment by agitated immersion, clean-in-place (CIP) spray wash, and an automated parts washer cleaning application. The test soils included:
- Extra emollient night cream
- Lip mask
- Intense moisturizing cream
- Baby sunblock with an FDA-registered drug active
- Bulk concealer with an FDA-registered drug active
- Moist SPF 30-day cream with an FDA-registered drug active
Critical parameters analyzed during the laboratory evaluation included cleaning action, change in temperatures, variations in cleaning chemistry, changes in cleaning agent concentration, multiple cleaning steps, variation in rinse and wash times, and water quality (Figure 4).7, 8, 9 A coupon was considered clean if it was visually clean and water-break free, and if its precoating and post-cleaning weights were equal (0.0 mg residue), as shown in Table D. 8 Once cleaning parameters were developed for the stainless steel coupons, testing was performed on the coated parts provided by the end user in the washer itself.
End user parts were sprayed with a riboflavin solution at 0.2 grams per liter water and dried for 4 hours. Parts were then placed onto the customized rack and loaded into the washer. After a short cycle the rinsed parts were unloaded and inspected with a UV light for possible traces of riboflavin (see Figures 5 and 6).
- 8. a. b. Hadziselimovic, D., and P. Lopolito. “Critical Cleaning of Carbomer Containing Products.” Journal of GXP Compliance 16, no. 3 (2012): 32–8. http://www.ivtnetwork.com/sites/default/files/IVTGXP0712_032-038_Lopolito%20PeerTitle-%7B1416310%7D.pdf
- 9. Ji, Wenchang, Wei Qi, Nitin Rathore, and Cylia Chen. “Bench-Scale Characterization of Cleaning Process Design Space for Biopharmaceuticals.” Biopharm International 22, no. 3 (March 2009): 32–44. http://www.biopharminternational.com/bench-scale-characterization-cleaning-process-design-space-biopharmaceuticals
The end user provided the following products to be used as soils for the load items. These were determined to be the most difficult to clean based on a grouping strategy:
- Lip mask
- Baby sunblock
- Bulk concealer
The washer supplier recommended the following parameters based on the laboratory evaluation:
- Prewash of 2–5 minutes at 60°C–80°C
- Wash with 5% v/v alkaline detergent (80°C, 15 minutes)
Parts were then covered with the end user–provided soils (creams), loaded onto the customized rack, and processed in the washer using the recommended cycle. Once the cycle was completed, parts were inspected (Figures 7 and 8).
As can be seen in Figure 10, some areas were not cleaned properly. The root cause was found to be poorly positioned T-joints with openings that hadn’t faced the washer side spay arms. This created areas where spray coverage was insufficient. The issue could easily be fixed by reorienting the components so that the problem areas could directly face the side spray arms. The loading procedure was updated to prevent the situation from reoccurring.
The FAT is a critical project milestone in the design phase of the life cycle model for an automated parts washer. The design of an automated parts washer is based on the URS, FS, and DS. The FAT also provides a unique opportunity for the end user to work closely with both the detergent and equipment suppliers to evaluate the washer and ensure it meets the intended design requirements. Detergent selection and cleaning parameters can be determined in parallel to the washer design and construction. The FAT allows end user personnel, under the guidance of equipment experts, to verify that the automated parts washer functions as intended. If issues occur or design changes are needed, they can be addressed during the FAT or added to a punch list for the equipment supplier, cleaning detergent supplier, or end user to be addressed prior to shipment or installation. A well-prepared and -executed FAT on an automated parts washer can reduce resources and time required for the development of SOPs and qualification testing.