Legislative Background
GP Solutions - Dose Guard Overview
Commercial Position
Main Benefits

LEGISLATIVE BACKGROUND

In the mid seventies UK legislation was introduced governing the sale of aspirin and paracetamol products. This stipulated that all solid dose products with the exception of powders and effervescent tablets would have to be packed into child resistant packaging.

There are two basic formats for packing these products, reclosable (plastic or glass pots/bottles) and non-reclosable (blister/strip packs).

A standard test was introduced by BSI whereby the child resistance of reclosable containers could be evaluated. This lead to the introduction of a number of solutions, the most common being the “clik-lok” and “line up the arrows” type of cap.

For blister/strip packs, no such standard could be agreed upon. The arguments being that due to the nature of the packaging and the fact that they were “unit dose”, they were inherently child resistant. In addition it was argued that there were two many variables in the make-up and content of the pack to make it a viable proposition. E.g. thickness of the foil, variation in heat seal adhesives, variation in blister packing machines, shape and size of the pack, shape and size if the dose etc.

Therefore instead of introducing a standard test for non-reclosable packs, the wording was changed to “blister and strip packs must be constructed of materials such as to make them resistant to opening by children”.

This of course meant that the two formats were not competing on a level playing field, a point made vociferously and constantly by the container manufacturers ever since.

The situation changed in the summer of 2000, when a 3year old child removed 44 iron tablets packed in pvc/foil blisters, swallowed them and died as a result.

A European working party on child resistance, of which the UK was a member, had been progressing slowly towards agreeing a standard for non-reclosable packs (implementation approx 2004), when this tragedy occurred. The UK decided that enough was enough and announced that it was going to press ahead with a unilateral child resistant test for non-reclosable packs. This it did and BS 8404:2001 was introduced on 21 st December 2001. This has now been replaced with the new European Standard EN14375.

The result of this standard is that the current legislation on aspirin and paracetamol can now be enacted for both types of packaging. I.e a level playing field is now in place and companies selling these products in non-reclosable packs can no longer claim that their pack is child resistant without proving it.

GP SOLUTIONS ( UK) LTD – DOSE GUARD™ OVERVIEW

GP Solutions are an independent packaging solutions company, with access to products and patents suitable for use within the pharmaceutical and healthcare industry.

Dose Guard™ is GP Solution patented and approved technology. Dose Guard combines child resistance with improved senior friendly access for non-reclosable blister packs and wallets.

Dose Guard™ is a self-adhesive barrier, suitable for application directly on to the following packaging formats.

1. All forms of cold and thermo formed blister packs.

2. Commercial & clinical wallets

A combination of multipart adhesive and die cutting technology provides increased child resistance in most blister packs without the need for re-tooling, validation and stability study analysis.

Each blister packaging line will require a labeling machine located between the sealing and die stations or at the out feed prior to checkweigher / cartonner.

COMMERCIAL POSITION

The changes described in this document will be the first major issue to affect non-reclosable packaging for over 37 years. The pharmaceutical industry will be faced with a clear choice either, retain the blister pack and move to a CRSF Label or laminate, or switch to re-closable containers.

In many cases the prospects for re-closable containers are unpalatable, due to the advent of The Patient Pack Initiative and the upsurge of calendar packs (which was initiated in the late 1990’s). It is our belief that the CRSF Label represents the most simple, effective and flexible solution for non-recloseable packs.

This assumption is based upon considerable market knowledge coupled with an exhaustive consultation with key players within the industry, over the last two years and more.

The understanding of the true potential and value of the Child Resistant issue is difficult to fully quantify. However, we can provide you with an insight into the magnitude and scale of the changes, which are about to take place.

From details provided by the MHRA we estimate that approximately 600 product licenses contain either aspirin and or paracetamol (this includes all dose formats). When you include iron based products it is not difficult to see the scale of the impact the new EN14375 will have.

MAIN BENEFITS

  • First change to non-recloseable packaging for over 37 years
  • Proven, Patented Technology
  • Unique opportunity to capitalise on a fast developing market place
  • Assume the pole position for Child Resistance – Lead through the industry
  • Attract new customers
  • Acquire a USP (unique selling point)
  • Low start up costs
  • High market awareness achieved
  • Full product development programme completed
For further information please contact us