SOP on Transfer Process of Packaging Material from LC to HC
Can someone provide an idea of a procedure on How packaging materials can be transferred from LC to HC without any available Hatches and only point of entry is the change room.
Can someone provide an idea of a procedure on How packaging materials can be transferred from LC to HC without any available Hatches and only point of entry is the change room.
HI FFQ,
Some context required.
product ?
process ?
standard ?
Where high-care areas are part of the manufacturing site there should be physical segregation between these areas and other parts of the site.
Segregation shall take into account the flow of product, nature of materials (including packaging), equipment, personnel, waste, airflow, air quality and utilities provision (including drains).
Where physical barriers are not in place, the site shall have undertaken a documented risk assessment of the potential for cross-contamination, and effective, validated processes shall be in place to protect products from contamination.
Vulnerable products and ingredients have, before entry to the high-care area, undergone a process to reduce any contamination by pathogenic bacteria (e.g. a chlorine wash of salad materials), or an early cook step (e.g. the use of pasteurised cream).
It is important that the high-care area is effectively protected from contamination from low-risk zones.
This is most effectively achieved through full physical segregation by means of walls which separate the high-care area from other factory areas.
Where a separate, fully walled-of area is not available, alternative procedures must be in place to segregate the high-care area.
The segregating barrier must be capable of preventing the risk of cross-contamination from:
• unauthorised access and movement between high-care and other areas of the factory except through designated changing areas
• transfer of materials, utensils or equipment except through designated ports with sanitising controls in place
• microbiological contamination which may be present in a low-risk environment
• airborne contaminants (e.g. dust particles or water droplets).
In assessing the suitability of the segregating barrier a risk assessment must be carried out and documented.
The method employed must be validated to demonstrate that the controls are effective in preventing cross-contamination.
The auditor will critically examine the arrangements to ensure that potential risks for contamination have been addressed and that the alternative controls are consistently workable before the solution is considered acceptable. (This will be recorded in the audit report.)
Where the solution is time segregation, the changeover between standard and high-care operations should be as infrequent as possible, as it is unlikely that a sufficient standard of cleaning could be reached if changes occur frequently during the day.
Fully validated procedures to change the area from low risk to high care are required.
These activities need to be taken into account when scheduling production, to ensure effective transformation of the area, including personnel.
If the same personnel are responsible for the area during low-risk and high-care operations, they must undergo a complete change of protective clothing.
Hi Charles,
Our product is Ready to eat wet salads(Mayo and Vinegar based) with add on (Lettuce spinach etc.)
Process is Cooking and Mixing
Standard BRC
Our Cook room is away from the packing room we need to transfer products and packaging materials to High Care tubbing room but our finished goods cool room which is low care is in between. Our cooked and mixed product passes through a low risk hallway then to High Care for Packing Tubbing the salads.
Hi Charles,
Our product is Ready to eat wet salads(Mayo and Vinegar based) with add on (Lettuce spinach etc.)
Process is Cooking and Mixing
Standard BRC
Our Cook room is away from the packing room we need to transfer products and packaging materials to High Care tubbing room but our finished goods cool room which is low care is in between. Our cooked and mixed product passes through a low risk hallway then to High Care for Packing Tubbing the salads.
Hi FFQ,
Thks but I'm slightly confused.
You cook the lettuce/spinach ? This would ususally be a high Risk scenario, not high Care ??
Perhaps meat is involved ??
Tubbing means placed in trays ??