Taking the first steps in hand sanitiser production

Companies are switching to manufacturing PPE and hand sanitiser to follow demand, but what could they be missing in their haste to capitalise on this exploding market. Rob Bussey from UK-based consultancy BPE, speaks about the top considerations for manufacturing of this product

As the UK begins to return to work among the "new normal" in the wake of the Coronavirus pandemic, BPE has seen an increase in enquiries from companies looking to diversify and provide items such as PPE and hand sanitiser.

We are beginning to see lockdown easing even further with some non-essential businesses and workers being allowed to return for the first time since March. Those businesses will be responsible for the health and safety of returning employees, including the implementation of extra equipment such as PPE or hand sanitisers.

Any companies with a new formulation must be authorised to be placed on the market

However, there are also those on the other side of the spectrum, where the "new normal" has forced them to remain closed for the foreseeable future.

In an attempt to adapt and survive, companies are capitalising on the increased demand on safety products by switching to alternative operations, such as the manufacturing of PPE and hand sanitiser.

But, any companies with a new formulation must be authorised to be placed on the market. Plus, other regulations in the manufacturing process will need to be considered, especially in the use of flammable alcohols and the increase risk of fire. Insurance companies are also keen to see that these considerations have been acknowledged.

Working closely with a number of relevant regulatory organisations, such as the World Health Organisation (WHO), Dangerous Substances and Explosive Atmospheres Regulation (DSEAR) and the Biocidal Products Regulations (BPR), BPE has been offering businesses advice and guidance on the safe manufacture through process designs that are safe, robust, and will stand the test of time.

First Steps

Carry out a risk assessment as this will form the basis of all UK safety legislation and provides an ideal way of approaching your new venture. For small operations you may be able to use a simple one size fits risk assessment template although different types of hazards often benefit from specific risk assessment templates.

You will also need to comply with the DSEAR regulations. Even when diluted, ethanol is likely to be flammable. While there are a number of requirements the principles are relatively straightforward:

Identify sources of release - Where will flammable vapours exist? Material transfers, spills, leaking outlet valves etc

Define the extent of the flammable atmosphere - This is typically done by following standards, within Europe this is dictated by IEC 60079-10-1

Identify potential ignition sources - BS EN 1127-1 lists 13 possible ignitions sources although many of these will not apply to small scale production units

Assess the risk - Risk is defined as the combination of consequence and likelihood, so how big is the extent of your flammable atmosphere and what is the chance of it encountering an ignition source?

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Safe storage

Not only do we want to prevent a fire from starting, but we should also minimise the possibility of fire escalating. There are a variety of hazardous material storage containers, providing a range of protection measures.

Don't forget it's not just your raw materials that are flammable. Depending upon your formulation your products may also be flammable, so ensure there is sufficient separation between final product and raw materials.

Fire safety is regulated under the Regulatory Reform (Fire Safety) Order 2005 and differs from DSEAR in that it applies more broadly. There are a number of aspects that you need to consider; prevention, detection, fire-fighting, and emergency response (training):

Prevention - Look at strategies to minimise combustible and flammable material as this is even more important considering the flammable nature of alcohols. Work carried out for DSEAR including ventilation assessment will count towards your fire prevention.

Detection - There is a requirement within the regulations to ensure that the facility is fitted with fire detection and alarms.

Firefighting - For large scale production this may involve sprinklers but for most small scale operations this will typically be limited to the use of a fire extinguishers.

Emergency response - What do employees need to do in the event of a fire.

Ventilation will be a key control measure

Safety measures do not just revolve around fire. The Control of Substances hazardous to Health regulations set out an employer's duties with respect to exposure to hazardous chemicals. Employees could be handling hundreds of litres of ethanol which is volatile. Ethanol vapours, when inhaled, will be readily absorbed into the blood stream leading to all the effects usually associated with intoxication.

Ventilation will be a key control measure. Does your facility rely on natural ventilation or is mechanical ventilation available? Whatever system you have you will need to assess whether it is sufficient to ensure the safety of your employees.

Also, in the event someone is splashed with a chemical you will need to provide a safety shower or eyewash station to mitigate the effects of exposure.

Machine safety

If your company has invested in machinery it is your responsibility to ensure the equipment that you buy is fit for purpose. You will need to carry out a risk assessment, considering amongst other things:

Ergonomics - can your operators easily access routinely serviceable parts?

Guarding - does the machine have moving parts and do they have suitable guarding?

Overheating - does the machine have hot surfaces? These need to be guarded to protect operators, but you may now need to consider the risk from flammable liquids.

Noise - in the UK you should be aiming for less than 80 dB, measured in situ.

e-Stops - do you have a sufficient number of e-Stops? And are they easily accessible?

Electrical safety - Has the machine been built to UK electrical standards?

Maintenance and isolation - Who will do the maintenance? Is there provision to safely isolate the machine's electrics, pneumatics and/or hydraulics?

Logistics

For waster, any items contaminated with alcohol or waste raw material may need to be disposed of as hazardous waste and will require special handling and disposal. With regard to labelling, the HSE make some specific statements about what can't be included. "Labels must not mention the terms 'low-risk biocidal product', 'non-toxic', 'harmless', 'natural', 'environmentally friendly', 'animal friendly' or similar indications, or include any medicinal claims".

Insurance companies are keen to see that considerations have been acknowledged

When the final step come in transporting the product, whether you are selling your product online, or supplying retail outlets, you will need to understand the applicable dangerous goods for transport regulations.

As you can see Environmental, Health & Safety regulations within the UK are wide ranging and comprehensive and can be a little daunting although in reality it is relatively straightforward. Many companies engage the services of a specialist, such as BPE, to help ensure their operation is safe.


N.B. This article is featured in the October 2020 issue of Cleanroom Technology. The latest digital edition is available online.