3 replies to this topic

[Sankani]

Hi All, 

 

I have recently joined a dairy powder export company (HACCP and export licence) where they receive app. 50 Tonne order from the customer for one SKU. Hence, changing the batch number every 24 hours introduces  lot of work for us (eg: reconciliation, internal testing, release, paperwork, label creation, cleaning etc) and add extra costs for the external testing. Therefore, we can introduce continuous manufacturing similar to “campaign manufacturing” in pharmaceuticals to cover up 1 order (50T product) across app. 1 week under the same batch number. (defining the batch  based on the quantity of the material produced)

 

For that we can conduct a thorough risk assessment to confirm the below;

 

1. Input material control, process conditions, environmental factors effect for operations
2. Quality of final product over the period of the intended production run.

• uniformity across batch by performing internal lab testing for sensory, wettability, bulk density etc.
• microbiological limits are within spec (by testing samples across the batch)                                                      

1. Process monitoring and control

• Variables being monitored at appropriate locations. (Input, in-process and final product attributes)
• Sampling plan including sampling locations and sampling frequency
• Batch release
• Process validation
• On going monitoring to confirm that it remains under state of control

1. Material diversion

• Non-conforming material can be segregated and removed without affecting the rest of the batch

1. Daily release testing
2. Specifications to be met
3. Equipment cleaning (cleaning frequency), wear and tear, preventative maintenance, cleaning validations for increased production run time, periodically verified cleaning results (during operation and after disassembly)
4. Potential failure mode analysis (micro growth, product quality or risk of contamination, recall)
5. Traceability is met during the week’s production
6. history of manufacturing records with no contaminations

 

It would be really great if you could kindly advise if this is a suitable way to convince the auditors as I have not seen a dairy powder manufacturer adopting this continuous manufacturing process.

 

 

Thank you very much. 

[Scampi]

Not the same, but when I was in Cannabis, a single lot of edibles was based on the volume of the resin, and the constant addition of all other ingredients into one continuous large batch made over multiple shifts. The caveat being that the production was continuous, no sanitation activities occurred

 

Where I am now, we issue one lot number per week with an identifier added for each shift (with varying inputs)

 

 

What do you believe the largest risk is?  Does your regulator have an issue with this?  If Australian Food Safety Standards do not have an issue with this, then a GFSI auditor certainly should not

[Sankani]

Thanks so much for the reply Scampi. My biggest concern is a recall. If you have an unique identifier per each shift - can you recall a specific amount of product in an event of recall (after conducting the risk assessment) rather than recalling the whole lot? 

Edited by Sankani, 19 June 2022 - 11:01 PM.

[Scampi]

Yes, we could recall a single shift if necessary as our system also includes a date code when the finished pallet is generated (for each pallet) so we can see what was produced and when