In this article we’re going to cover in detail, the requirements for chemical control, as this continues to be one of the most common non-conformances. In the Standard it’s only a couple of clauses, but there’s a lot packed into the requirements.
The requirements for chemical control
The aim of chemical control: chemicals must not contaminate the product and must be fit for purpose. This is achieved by:
- Selecting the right chemical
- The use of SDS and technical specifications to develop appropriate procedures
- Validating that the procedures work
- Having a list of chemicals that have been approved for use
- Verify that the chemicals are working
- Ensuring chemicals are labelled at all times
- Safe and secure storage of chemicals
- Training is provided for those that need to handle chemicals
The aim of chemical control
You need chemicals, there’s no getting away from them. Without them, you wouldn’t be able to clean the equipment that you use and unclean equipment would cause contamination to the product. Or, you wouldn’t be able to lubricate the equipment you use, and unlubricated equipment could cause metal on metal contact, which in turn could also contaminate the product. However, if you don’t control the chemicals you use properly, the chemicals themselves can cause contamination to the product.
So, the aim of chemical control is three-fold:
- You need to make sure the chemicals you use don’t pose a chemical contamination risk.
- You need to make sure that the chemicals you use are suitable for what you want to use them for. Which means, they need to do the job you want them to do properly (such as cleaning or lubricating).
- You need to make sure that the chemicals you use are suitable for use with the food product you are making. Which means that they must comply with food regulations and they must not contain allergens.
The last two points need to be considered when you are selecting the right chemical.
Selecting the right chemical…
As we’ve just said, when you are selecting a chemical, you need to consider:
- Will it work?
- It is suitable for use with food?
- Does it contain allergens?
We’ll come on to proving that the chemical works, but before you do that, you need to select a chemical that does the job you want it to. That seems obvious and very straight forward, but it’s not quite as simple as that.
Cleaning chemical control
If the chemicals you are using are for the purpose of cleaning, you need to consider what kind of clean you want to achieve and what conditions you want to clean under. To do this, it’s probably worth mentioning the cleaning triangle.
To clean effectively, you need three elements: Temperature, time and friction. If you remove one of these elements – the clean won’t be effective. However, you can adjust the balance of the elements for effective cleaning. For example; you can lower the temperature of the water, if you increase the amount of time and friction. You could increase the temperature and friction and reduce the amount of time.
So, when you’re selecting a chemical for cleaning, you need to know how much time you have to clean, what temperature you can achieve and how much scrubbing (friction) you can apply. Finally, you need to make sure that the chemical doesn’t cause a contamination problem, which means you need to know if you can rinse the chemical off or not. Chemical manufacturers develop different chemicals to suit lots of different situations, so you need to know what you want, to be able to select the right chemical.
Engineering chemical control
If you’re wanting a chemical for engineering purposes, the same principles apply. Many equipment manufacturers will recommend chemicals to use with their equipment, based on the needed functionality of the chemical. Using the wrong chemical (or lubricant) on a piece of equipment will mean that the lubricant doesn’t do the job it was intended for, resulting in failure of the equipment.
Operational chemical control
These tend to get forgotten, as they are not seen as chemicals. You need to include all chemicals, not just the ones you see typically as chemicals, such as cleaning chemicals or lubricants. To do this, you need a way of identifying all chemicals.
What makes something a chemical?
Well, the easiest way to do this is to look for the hazardous symbols. Any chemical, by law, has to have a hazard symbol, which explains how hazardous it is to people and the environment. Here are the symbols and their meanings:
Chemicals that are used, which tend to get forgotten are things like:
- Printing or coding inks
- Printer toners
- Cooling chemicals, such as glycol
Is it suitable?
Once you know what you want the chemical to do and you’ve selected one that is suitable for the job you want it for, you then need to check to make sure it’s suitable for use with food. This means two things:
- It must meet the regulations with regard to chemicals suitable for food use
- It must not contain allergens
In the EU there is a piece of legislation that ensures that we can only use chemicals for food use, where they meet certain rules. This piece of legislation is called Regulation 1935/2004 and the following link provides details for the UK: www.food.gov.uk/business-guidance/food-contact-materials
In America the FDA provide similar guidance, which can be found at: www.fda.gov/food/food-ingredients-packaging/packaging-food-contact-substances-fcs
Some chemicals contain allergens, so you need to check this if you’re going to use them. Most good chemical suppliers who produce food grade chemicals should know that they need to cover allergens and will provide you with a statement or specification that states what, if any, allergens the chemical contains. Make sure the chemical you want to use doesn’t contain allergens and also, that you have evidence to prove it.
Using SDS and technical specifications
So, once you have selected the right chemical and you’ve checked to make sure it’s suitable for use with food and it doesn’t contain allergens, you need to make sure you use the information provided by the supplier – to put the right handling procedures in place. This means that you need a procedure to use the chemical, which:
- Ensures that it is safe to use from a health and safety point of view
- Ensures that the chemical works, by following the manufacturers instructions
- Ensures that is doesn’t pose a risk of chemical contamination
An SDS is a safety data sheet. Sometimes also known as a MSDS – a material safety data sheet. This document contains all the information you need to ensure that it’s handled, so that it doesn’t put health and safety of personnel at risk. It will explain what personal protective equipment people need to wear to protect themselves, when handling it. It will explain if there is any explosion risk. It will tell you about all the hazards relating to people.
This information should be used, to create a risk assessment for the use of the chemical and then, the risk assessment should be used to create a safe system of work. A safe system of work is basically a step by step documented process of how the chemical must be handled, to ensure the safety of those who are handling it.
When you know how to handle the chemical safely, then you need to use the technical specification to develop a method to use the chemical so that it does what it’s intended to. The SDS is all about using the chemical safely, whereas the technical specification contains the information about how to use the chemical effectively.
If it’s a cleaning chemical it will tell you at what concentration to use it, at what temperature, how long to leave it on (known as contact time), how much scrubbing to do and if it needs rinsing off afterwards. You need to follow the manufacturers instructions for cleaning because otherwise they won’t do the job you need them to. The technical specification may provide you with different methods for different applications so you need to pick the right one for your application.
Also, it’s important to follow the instructions for cleaning chemicals because it will tell you if you have to rinse the chemical afterwards. If you need to rinse the chemical off and you don’t do this, you risk contaminating your product with chemical, especially if it’s a food contact surface you’re cleaning.
Validating that the procedure works
Validation is only for cleaning chemicals, you don’t typically need to validate other chemicals. Check so far, that you have carried out the below tasks:
- Selected the chemicals to do the job you need it for
- You’ve made sure it’s food grade
- It doesn’t contain allergens and you can prove it
- You have used the information provided by the manufacturer through the SDS to develop a safe system of work for handling the chemical
- You have developed a procedure using the technical specification, which will ensure that the chemical works.
Now, you need to prove that the procedure you have developed works, by validating it. To validate is to prove something will work. So here, you need to prove that the cleaning method, using the chemical works. By this, we mean it does what you want it to. To do this, you need to be clear on what you want it to do.
- Do you want it to provide a sterile surface?
- Do you want it to remove allergen residue?
- Or do you want it to achieve an ATP swab result of less than 100, for example?
Once you know what you’re trying to achieve, you then need to prove that the chemical does this using the method you’ve provided. To do this, you’d need to prove that the surface you are about to clean is dirty. So you’d swab it to prove it is. Then, you do the clean following the instructions you’ve laid out in your procedure. Because you’re validating the chemical you would need to record all the key criteria, such as:
- The chemical contraction you’ve used (how much chemical was mixed with how much water)
- The temperature of the water used
- How long it was ‘scrubbed’ for
- How it was scrubbed
- How long (exactly) the contact time was,
- What temperature the rinse water was, how it was rinsed and for how long
- You also need to record the date, the time, who was involved, and who did the clean etc.
Once the clean is done, you’ll then need to swab it again. Now, this is important – when you’re setting up your cleaning procedure, you should identify which parts of the equipment are the most difficult to get clean. These will become your key inspection points. Because if you check these and they are clean, you know that everything else is clean. It’s these key inspection points you should swab – because this is worst case.
You only need to do this validation once, unless something changes. If you change the method, or the equipment or if you change the chemical, then you need to do it again.
Having a list of chemicals that have been approved for use
Now you’ve checked that your chemical works and you have proved it, you can then approve it for use. This is when you put it on the approved chemical list.
Only chemicals that are on this list can be used. And, to use a new chemical, or change a chemical to another one, you need to repeat all of the above steps again, in order to approve it and put it on the approved chemical list.
Verifying that the chemicals are working
After the chemicals are approved and in use, that’s not the end. You need to verify that they are being used correctly. This would include checking the chemical concentration, including cleaning in your GMP inspections, or carrying out systems audits of the chemical controls.
If you use chemical in a CIP system, you’d also need to verify temperature, flow and rinse waters.
Ensuring chemicals are labelled at all times
It’s really important to make sure chemicals are labelled, so that they don’t get mistaken for something else. We’ve had personal experience of personnel putting chemicals into children’s drinks bottles (which were used on the line to pack the product into) and leaving them on a table by the line.
Can you imagine if someone took that bottle on the line by mistake, and it was then drunk by a child? Putting chemicals into containers which are intended for food is a major no-no! Putting chemicals into any container which is not clearly labelled, so that it’s clear it contains chemicals is a really unsafe thing to do.
People using chemicals won’t decant chemicals into food containers on purpose. Nobody comes to work to do a bad job, or to cause an accident. There is normally a very valid reason for them doing something unsafe. Talk to those who use the chemicals, or try doing the job yourself, to understand the problems they face. If you’re asking personnel not to decant chemicals at all, is that practical? If they need to decant chemicals to use them, then provide them with a suitable container to do this, which is clearly labelled.
Storing chemicals safely and securely
Chemicals should only be used by those who are trained to use them. This is to keep the individuals safe and those around them safe and also to protect the product from contamination. To ensure that people who are not trained to use chemicals, can’t actually get to them, you need to make sure they are stored in a secure location.
Secure, means locked up. Chemicals should be stored in a locked cupboard or storage area. Only those that have been trained, should be issued with a key. Also, think about the chemicals that you have about the factory, that are in use. These need to be secure too. You can get chemical holders, which are lockable. You can also lock off dosing systems, so you can use a key to dose out the chemical.
Training those that need to handle chemicals
If you think about it, we’ve covered a lot that chemical handlers need to be trained in. They need to know:
- The safe system of work to handle the chemical safely
- The procedure for using the chemical
- How to verify that the chemicals are being used correctly
- How to ensure that chemicals are always labelled
- How to ensure that chemicals are securely stored
- And they need to have an awareness of the risks of not handling chemicals correctly, for both:
- personal safety purposes
- and also with regard to the product
Training is key and needs to be up to date. Which means it needs re-doing when something changes, whether that be the safe system of work, the procedure, the chemical or the storage and labelling controls.
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