Eu Requirements e Liquids Cleanroom

The regulation of e-cigarettes is different in every EU country. For instance, some have no regulations in place at all, while others ban them entirely. The UK is one such country which has enacted strict restrictions guiding the sale of e-cigarettes and e-liquids.

In the UK and US, it is legal to sell e-cigarettes and e-liquids to adults. In 2012, the European Commission adopted a proposal to reduce the The Tobacco Product Directive (TPD), which included proposals that restricts the sale and use of e-cigarettes.

In 2013, it was agreed that cross-border marketing should be regulated, just like tobacco products.  In 2014, the European Parliament passed regulations that established quality control for vaporisers and liquids. Subsequently, companies must disclose the ingredients in the liquid and include child-proofing for liquid packaging.

Modular Cleanroom Benefits

  • Modular Construction
  • Quick Assembly Time
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

UK regulations for e-cigarettes

E-cigarettes and e-liquids have enjoyed monumental growth in the past few years. Sales are predicted to reach $32 billion by 2021 in the US. However, popularity has led to closer scrutiny, which in turn saw the UK introduce new rules for refill containers and electronic cigarettes containing nicotine.

The Tobacco Product Directive (TPD) of 2014 introduces new rules to:

  • Ensure consumers have the correct information to help them make an informed choice
  • Establish minimum standards for the quality and safety of all refill containers and e-cigs
  • Foster an environment that protects children from using e-liquids

Cleanroom Design, Build & Validation

  • Budgeting and planning
  • Engineering, design & layout
  • Airflow and filtration design
  • Construction and Installation
  • Full Certification of our product
  • Industry-specific equipment installation
  • Validation

2017 requirements

  • Prohibit the use of specific ingredients, including caffeine, colouring and taurine
  • Require tamper evidence and child-resistance on nicotine-containing products
  • Include new labelling warnings and requirements
  • All e-liquids and e-cigarettes should be notified to MHRA before going on sale
  • Limit the maximum volume of e-liquid for sale to 10ml
  • Restrict e-cigarette tanks to a maximum of 2ml
  • The strength of e-liquids cannot exceed 20mg/ml

UK laws that restrict smoking in public places do not cover e-cigarettes, but individual businesses can choose to ban or allow them. For instance, public transport such as trains, coaches and airports do not allow the use of e-cigarettes.

Healthcare professionals and consumers can report safety concerns and any side effects of refill containers or e-cigarettes to MHRA, using the Yellow Card. You can also report non-compliant or defective products to the MHRA.

In 2016, new regulations from TPD required all retailers to submit information about products they wanted to sell in the UK in order to qualify as a producer. Notably, nicotine-containing products categorised as medicines are not covered under TPD.

Modular Cleanroom Services

How Total Clean Air can help you build a TPD compliant Cleanroom

The ability of a producer to serve customers with the purest liquid made from locally sourced pharmaceutical grade produce is a necessity. Laboratory equipment used for measuring, testing and mixing should meet regulatory standards, while clean environments provide a sterile, contaminant-free space for e-liquid blending and packaging.

In line with recent regulations for the manufacturing of e-cigarettes and e-liquids, Total Clean Air offers TPD and e-liquid Cleanrooms that ensure your product complies with TPD classifications. To be considered a supplier to the major UK retailers, your e-liquid company will need an ISO Class 7 or ISO Class 6 controlled manufacturing environment.

For TPD compliance, a modular Cleanroom maintains industry standards by minimising pollutant contamination. We install HEPA filters that filter particles as small as 0.3 microns in size. To filter out smaller particles, we install ULPA filters, instead of HEPA filters.

Total Clean Air will create a Cleanroom that maximises your existing space for an efficient and workable manufacturing environment. Your bespoke Cleanroom will include temperature control, HEPA filtration, jigsaw flooring and interlocking doors.

Cleanroom Features

High Standard e-liquid Cleanrooms

Our high-quality HEPA filters are 99.9997% efficient at 0.3 microns for the positive pressure required. The e-liquid Cleanroom unit provides an excess of 100 air changes per hour. Meanwhile, the Clean Air Module installed on the ceiling removes particulate impurities and chemical fumes from the environment.

We use an aluminium framework, solid aluminium composite and polycarbonate infill panels to ensure our e-liquid Cleanrooms are robust and cost-effective. The flexible nature of a modular design ensures it can be expanded in the future when production expands. We also include a range of e-liquid Cleanroom manufacturing equipment in your design, including:

  • Customised windows
  • Air Showers
  • Customised door design
  • Pass-through chambers
  • Fan Filter Units
  • Radius coving

Cleanroom Industries/Sectors

Contact Total Clean Air today for your e-Liquid Cleanroom

Whether you need a small, mobile lab to contain your e-juice mixing process or a large e-liquid manufacturing facility, we can help. Total Clean Air has over a decade of experience designing and building TPD Cleanrooms that adhere to e-liquid manufacturing processes.

Types of Cleanrooms

phillip.godden
Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

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