FAT procedure for hygienic vessels 2

[funsharer]

Hi, I am an engineer working for a biopharmaceutial company and will visit our vessel vendors for FAT.
What would be the proper FAT procedure for hygienic vessels? Please help me with this.

One more question is which vessels we should go thru. CIP validation test procedure(using spray ball). Should we do the test procedure for WFI storage tank or any other water storage vessels? Your kind help will be a big help to us.

Thank you,

John

 

[quark]

I would prefer CIP validation test for any vessel which is cleaned with detergents.

Though I didn't have standard protocols, few points you have to consider are,

1. Material test certificates.
2. Pressure Testing.
3. Internal finish, if you specify any. (As far as possible you should insist for two point calibration of profilometer. One above the vessel roughness and one below because the error may not be linear)
4. Weld seam irregularities and cleanliness (proof or RT or dye penetration as per your specs)
5. Drainability of the vessel.
6. CIP (with milk powder generally or talk)
7. Food grade certificates of all elastomers.
8. General ambience of the work shop.

Regards,

 

[funsharer]

Quark, thank you for your kind reply and it sure will help me to do the job. I read some of your advises in some other forums and know you are very active here, which is nice.
Your reply have me come up with a question , when we add FAT report and vendor prints to validation documentation, which documents should it be added to? DQ or IQ,OQ execution data? If you know, please advise.

Thanks ,

 

[quark]

Recent trend is that FAT and SAT are considered as separate documents and only you have to give their references where ever you use the data(no need of duplication) except calibration of gauges. Though you do calibration of gauges during FAT, they should again be calibrated at site.

The chronology of validation is DQ, FAT, IQ, OQ (+SAT) and PQ. In my view FAT and SAT are a binding between supplier and the user.

Regards,

 

[WingTipHsu]

Hi, John
Here's a generic I recently drew up.
"Factory Acceptance" is mechanically verifying that the purchased system will perform as specified, by checking the engineering subsystems.
You may wish to consult the "pre-check" that most manufacturers use, because that information complements the FAT activities.
You might also want to use riboflavin for CIP testing; it is water-soluble and will luminesce under an ultraviolet lamp. Apply the riboflavin to the process surface, verify with the UV, operate the CIP for a specified time, check with the UV to see if the riboflavin has been removed. I don't recommend the use of talc.
Generic FAT checklist:
1. Check FAT protocol drawings, verify current revision, verify final owner acceptance
2. Check views of general arrangement/assembly drawing and verify against the machine.
3. Check emergency stop, resets, electrical drawings, pneumatic circuit from regulator to vibrator, mechanicals, verify instrumentation, physical dimensions, arrangement, accessibility.
4. Check wiring according to electrical schematic; perform 10% (minimum) point to point check using
Continuity test performed on the following wire numbers:
Between
Between
Between
Between
5. Check maintenance accessibility safety, ergonomics).
6. Motor Control Center and Timer panel
1. Check materials of construction against spec
2. Blender, frame, valve, product contact surfaces
3. Bearings, bushings, gearbox, lubricants, seals, valve gasket.
4. Check process contact surface finishes
5. Discuss options
6. Discuss recommendations
1. Check operating Manual existing compare machine number to book.
2. Maintenance manual
3. Check book for spare parts.
4. List of recommended spare parts.
"5. Verify all main suppliers in manual, and mech. drawings.
to be correct"
6. Check "Installations and Operating Instructions" manual to ensure the operating instructions are clear and can be easily followed.
1. Check and verify over head dimensions.
2. Operating heights: clearances
3. Maintenance heights: access
4. Skid height, width, depth, weight
5. Depth of machine
"1. Check the metal surface finish and verify the check was done against a standard "
2. Check internal surface visually and photograph
Welds
Finishes
fittings
connections
3. Mark any unsmooth surface inside the machine to repair
and photograph it.
4. Check the external finish.
Check welds on shell for smoothly ground welds.
Check welds on frame for smooth finish.
Check welds on motor covers
Check welds in belt covers.
Check welds on access covers.
valves
covers
housings
paint finishes
Nameplates
1. Pressure hold
2. Verify for leaks, on lids by hear and touch.
3. Hydrostatic
4. Verify for leaks, on air seals by hear and touch.
Remove motor covers and check for overheating, excessive vibration
1. Operate at low speed for one half hour. Check for overheating, excessive vibration and noise.
2. Operate at high speed with intensifier for one half hour. Check for overheating and excessive vibration and noise.
3. Safety check the operation of low air switch. Turn off the main air supply, the "Pressure Low" pilot light is lit and the blender and intensifier bar will not run.
4. Actuate systems
5. Check the operation of safety emergency stop. Pressing the "Emergency Stop" pushbutton on the panel will trip the safety relay thus removing power to the motors, drives, and control power. The "System Ready" pilot light goes off. To recycle power, turn and release E-stop pushbutton, then press "E-Stop Reset" and the "System Ready" pilot light will be lit. The unit is ready to operate.
6. Check the "Hand / Auto" functionality and ensure all modes work as designed.
7. Verify emergency stop resets
8. Verify tightness of process connections

Standards
SOPs
Heat sheets
Material certifications
purchase requisitions
Raw materials specifications
O&M manuals
shop drawings
assembly drawings
shop traveller
QC documentation

 

[fuctifino]

I am interested in the riboflavin sprayball tests. Unfortunately i cannot source any Riboflavin. Are there any suppliers in the UK ??

Thanks in advance

 

[dtreacy]

This thread seens to have died off. However to answer the last question. Riboflavin is relatively easy to find as it is Vitamin B2.
Observed under UV light it glows Green Florescent