Find out how to validate your facility when you seek approval to open, including special requirements for continuous and blood processors.
You need approval from the Animal and Plant Health Agency (APHA) to open an animal by-product (ABP) processing facility.
Once you have applied for approval, you must validate the facility to show you can treat ABPs effectively. APHA officers will inspect your facility as part of the validation process.
If you are successfully validated, you will be given a document setting out your operating conditions. Once your facility opens, you will need to follow the guide to how to operate an ABP processing facility.
Documents you need to provide
As part of the validation process you will need to send the following to APHA:
- a flow diagram which explains in detail how you process ABPs in your facility
- any graphs, data or calculations for tests that are described in this guide
- a Standard Operating Procedure (SOP) and Hazard Analysis and Critical Control Points (HACCP) plan to explain how you control important conditions at your facility, such as temperature and pressure
You can combine your SOP and HACCP in to a single document, and it is up to how you present them to APHA.
Processing conditions you need to control
Your SOP and HACCP document needs to explain how you control the size of material, temperature and, in some cases, the pressure level in your ‘cooker’ (the machine where you heat treat ABPs).
How to control material size
You need to crush ABPs into small pieces of no more than 150 millimetres (mm) before you feed material into a cooker for processing. (The exact size depends on the treatment method you use). This is to make sure the material is ‘cooked’ all the way through.
You can use any machinery to crush the material, for example mincers, cutters or breakers. You need to set up the machinery to make sure that material larger than the maximum size allowed for your processing method can’t pass through. You do this by measuring the size of the holes in a mincer, or the anvil gap in a cutter, for example. You will need to make the gaps smaller if they are larger than the maximum size of material allowed for your treatment.
During validation you should record the size of the anvil gap, how frequently it is checked, and how it is repaired if the gap is found to be the wrong size.
As well as monitoring the size of the anvil gap, you should manually measure the size of some of the material that has been through the crusher, to confirm it meets the size requirements for your treatment method.
How to control temperature
You need to install a permanent thermocouple (temperature measuring device) in your cooker to measure temperature when processing is taking place.
During validation you will need to plot a graph of temperature against time for each treatment method that you plan to use. This is to check you are meeting the time and temperature requirements for each treatment](https://www.gov.uk/how-to-operate-an-animal-by-product-abp-processing-facility#approved-processing-methods).
Once you are approved to open, you will need to continue recording temperature whenever processing is taking place.
You will also have to pay a company to inspect your thermocouple once a year to make sure it is working correctly (you may need to provide a certificate of inspection if you are inspected by APHA).
How and when to control pressure
If you are using a treatment method that requires a certain pressure level, you need to install a pressure gauge in your cooker to measure pressure during processing.
During validation you will need to plot a graph of pressure against time for your pressure treatments. This is to check you are meeting the pressure requirements for pressure sterilisation. You will need to state in your records whether you are recording pressure above atmospheric pressure, or absolute pressure (which is one bar higher).
Once you are approved to open you will need to continue recording pressure whenever a pressure treatment is taking place. You will also need a company to inspect your pressure gauge once a year to make sure it is working correctly (you may need to provide a certificate of inspection if you are inspected by APHA).
Additional requirements for continuous processors
If you are using a system where you continuously feed ABP material into your cooker (rather than processing material in batches) you will need to carry out a processing test as part of the validation process. Read the guide to carrying out a processing test.
Your SOP and HACCP document will also need to explain how you control the following:
- the rate of flow of ABP material into your processor
- the rate of flow of fat into your cooker (if you add fat)
- additional temperature controls that apply
How to control material flow rate
You need to measure the rate at which ABP material flows into your cooker.
It’s up to you how you control the material flow rate, but you must measure flow into the cooker at all times. You can’t simply calculate an average flow rate because the flow rate may change over time if it is not regulated.
Your validation documents need to state what method you’re using (for example the revolutions per minute of the screw feeding material into your cooker.)
How to control fat flow rate
If you continuously add additional fat into your processing mixture, you need to also monitor one of the following:
- the flow rate of additional fat into the cooker
- the amount of fat in the cooker at any given time
It’s up to you how you control the fat flow rate, but your validation documents need to state what method you are using (for example using a flow meter to measure the rate at which fat flows into your cooker).
Additional temperature controls
You need to install at least 3 thermocouples in your cooker to record temperature at different points in the cooking process.
1 thermocouple should be at (or as close as possible to) the entrance to the cooker and 1 should be at (or as close as possible to) the exit.
The others should be evenly spaced within your cooker.
So, for example, if you have 3 thermocouples place them at the start, half way point and exit of the cooker. If you have 4 thermocouples, place them at the start and exit, and at a third and two thirds of the way through the cooker.
As part of validation you will need to plot graphs of temperature against time during the cooking process for each of your thermocouples, to show that you are meeting the time and temperature requirements for any processing method that you plan to use. (You will need to include pressure on these graphs if you plan to use a pressure treatment method).
You can use an infrared temperature gun to measure temperature at different points, instead of installing many thermocouples.
Additional requirements for blood processors
If you are seeking approval for a blood processor, your SOP and HACCP document needs to show how you:
- ensure blood only moves through your facility in one direction
- keep track of unprocessed blood
Ensure blood can only move in one direction through the facility
You need to ensure blood can only move in one direction through your processing facility. Specifically you need to make sure:
- when untreated blood arrives at your facility it enters the storage tank, or tanks, for unprocessed blood through a one way inlet
- there is a single one way outlet pipe from each storage tank for unprocessed blood into the cooker
- there is a single one way outlet pipe from the cooker to the storage tank for processed blood
- there is a single one way outlet pipe from the storage tank for processed blood to vehicles that transport processed blood away from your facility
The only exceptions to the single one way inlets and outlets are as follows:
- you need at least one additional outlet pipe from the cooker to drain it during an emergency (these additional outlets should be sealed shut during normal operating)
- you need to be able to access the cooker and the storage tank for processed blood to take product samples (you can read more about sampling requirements for ABP procesing facilities and how to take samples)
You need to provide APHA with a detailed route map for all the pipework in your facility during the approval process. You can’t alter the system once you are operating without APHA agreement.
How to store untreated blood
You need to store all untreated blood in a closed storage tank until it is processed.
You need to have a system to automatically record:
- flow of blood into the storage tank
- volume of blood inside the tank at any given time
- flow of blood out of the tank
You must reconcile these volumes everyday to make sure that you haven’t lost any unprocessed blood.
Setting up a system to permanently mark high risk material with GTH
To be validated you will need to to set up and successfully trial a system to mark high risk ABP material with GTH (glyceroltriheptanoate). GTH is an artificial fat that survives the extreme heat treatment used to process ABPs. Adding GTH to ABP material means the material can be traced.
Testing for GTH
You will need to agree a contract with a laboratory to test samples of your finished product for GTH.
In the UK only 2 laboratories can carry out the test:
You can also send your samples to laboratories in other EU countries if they are accredited by their governments to carry out the test.
Add between 30 and 50 grams of GTH per tonne of ABP material at a point in your processing:
- where the ABP material being processed is at a temperature of least 80°C
- that is early enough in the process to ensure the GTH mixes thoroughly and all of the material is marked
Once you have decided on your dosage carry out a test run for up to 5 days. After at least 24 hours of the test run, take a sample of processed material every 2 hours for 24 hours (giving you 12 samples in total).
Send the samples to the laboratory you have contracted for testing. Each sample must have at least 250 milligrams of GTH per kg of fat. It is recommended, but not required, that on average the samples have at least 300mg of GTH per kg of fat.
If your samples don’t meet these standards increase your GTH dosage. Keep running test periods and increasing your GTH dosage until your samples meet the standards.
Once you have completed the test run, carry out a 5 day trial. Take 2 samples of processed material on each day of the trial (for a total of 10 samples) and send them for laboratory testing.
Your samples need to meet the same standards as in the test period:
- each sample must have at least 250 milligrams of GTH per kg of fat
- it is recommended, but not required, that on average the samples have at least 300mg of GTH per kg of fat
Increase the amount of GTH you apply and repeat trial periods until your samples meet these standards.
Approval for changes to your processing method
An APHA officer will consider your validation documents. If there are problems with the information provided, APHA will contact you. If you pass validation, you can apply for approval from APHA.
You will need to repeat the approval process, including carrying out validation again, if you make significant changes to your processing method. Significant changes include:
- processing different raw materials
- changing machinery
- changing the flow rate
If the changes are to restore your facility to a previous set up that APHA has already approved, this may not apply. But you must still contact APHA to discuss the situation.