Enersol Newsletters

February 2015

Enersol introduces next generation condom inflation system
AUIS

    ENERSOL is excited to unveil its Automated Unrolling Inflation System (AUIS). The system is designed to speed up operation, increase productivity and ensure consistent unrolling and operation.

    Enersol’s AUIS was recently on display to visitors for the first time in Sydney, Australia. The advanced condom inflation burst volume and pressure system automatically unrolls male condoms onto the test head, resulting in ultra-fast and consistent operation. The technician simply places the condom on the top of the test head and the system automatically unrolls the condom, lowers the cabinet window and inflates the condom. Upon bursting the system returns to the start position, ready for the next condom. All the while, the testing software records all of the live-feed data.

    Apart from the obvious advantage of increased productivity, the system offers consistency of unrolling, so that all condoms are unrolled in the same way, regardless of which operator is using the machine. This action is expected to result in higher repeatability within laoratories.

    Like its manual-unrolling companion model (the AIS), the AUIS is easy to calibrate and is delivered with the necessary calibration devices for volume and pressure. Enersol installs the AUIS on-site and trains staff in the use, general day-to-day maintenance and calibration of the system.

Contact Enersol for more information about the AUIS

New ISO4074 condom standard released


    By Dr John Gerofi

    In September 2014, the new edition of ISO 4074, for male condoms, was finally published. The previous edition had been in vogue for 12 years.

    At first sight, the changes may appear to be minimal, since the major tests and requirements remain the same. On the other hand, closer examination reveals many differences. The standard itself provides a list of differences in the foreword, and it includes 17 points, which are discussed in more detail on ENERSOL's website.

    The last point in the list reveals the ISO committee's ambivalent and changing attitude to allowing a wider range of condom sizes. The matter had been under consideration for about 10 years. It was at first rejected, but then came close to being incorporated in the standard in the same way as traditionally sized condoms. At the last moment, a vociferous opposition appeared, and all condoms outside the range 45 mm to 57 mm were deemed not eligible to comply with the standard. These condoms were then described, along with "recommended requirements" in an annex.

Then, one of the manufacturers involved in the opposition started marketing condoms in the range 57 to 75 mm, and the draft standard was revised to allow for these products to comply. Meanwhile the smaller condoms (less than 45 mm wide and/or less than 160 mm long) remain specified in the annex but there are several statements in the body of the standard stating that they cannot be claimed to meet ISO 4074. Although the standard itself proclaims that these products cannot meet it, the standard's own annex P states requirements for the products quite specifically. It must therefore be open to manufacturers to state at least that their products meet Annex P of ISO 4074. It is likely that most major purchasers of condoms will phase in the changes to ISO 4074 over the next few months. To deal with the wider range of sizes (even the larger condoms) and to modify the testing equipment for the new conductivity tests will require equipment modifications.

To describe the fine detail of the changes would require a much longer article. Below are the 17 points:

  • The maximum lot size is limited to 500,000
  • There are now requirements to comply with ISO 10993
  • There are recommendations for bioburden monitoring
  • Requirements for extra strength condoms have been replaced by requirements to justify any additional claims
  • Higher air-burst volume limits have been introduced for condoms whose width is between 65 and 75 mm
  • The specifications for the collars used in airburst testing have been altered to require a minimum radius of 2 mm where they contact the condoms
  • The volume of water used in the conductivity test has been raised to be the same as in the visual test
  • Higher volumes of water are now specified for leaks testing of condoms wider than 56 mm or longer than 210 mm
  • In conductivity testing, the voltage is now measured from the moment of first contact with the water
  • The ASTM "hang and squeeze" method for leaks testing has been allowed by reference
  • A limit has been introduced for the number of packs found with visibly open seals
  • The approach used for accelerated shelf life determination has been changed completely
  • Real time stability testing now requires leaks, inflation and package seal
  • The procedure for determining thickness using a micrometer has been re-instated
  • Removal of lubricant using an aqueous surfactant solution has been added as an alternative to isopropanol
  • There have been revisions to the labelling requirements and the requirements for additional information to be supplied with the condoms
  • Recommended requirements have been introduced for condoms narrower than 45 mm and/or shorter than 160 mm.

Enersol offers training courses and seminars on ISO4074:2014 and other aspects of male condoms and testing. Such events are held at its head office in Sydney, Australia and office in Penang, Malaysia. The courses and seminars can even be held at your office, or conference location. Contact Enersol for more information about a seminar or training course at your facility.

Contact Enersol about ISO4074:2014 courses & seminars

Ansell against Reckitt Benckiser

    By Dr John Gerofi

    Ansell announced that on 14 November 2014 the Company and Ansell Healthcare Products LLC filed a patent infringement lawsuit against Reckitt Benckiser (Australia) Pty Limited (the manufacturer of Durex condoms) and other related parties.

    The action, filed in the New South Wales District Registry of the Federal Court of Australia, claims that Reckitt has infringed Australian Patent No. 2009241426, titled "Dip-formed Synthetic Polyisoprene Latex Articles with Improved Intraparticle and Interparticle Crosslinks".

    Both companies had developed synthetic isoprene condoms and have been marketing them in other countries. The Patent was applied for on 27 April 2009 and granted on 6 September 2012.

    Ansell is claiming that the "Durex RealFeel" condom infringes a number of claims of the patent, resulting in loss of sales to Ansell's non-latex SKYN® condom product.

Ansell is seeking to prevent Reckitt:

  • importing the Durex RealFeel product into Australia;
  • Selling, supplying or otherwise disposing of the Durex RealFeel product in Australia; and
  • Offering to sell, supply or otherwise dispose of the Durex RealFeel product in Australia.

In addition, Ansell is seeking, among other orders:

  • An order for delivery for destruction of all stocks of the Durex RealFeel product in Australia that are in the possession, custody or control of the Respondents;
  • Damages or an account of profits, including additional damages pursuant to section 122(1A) of the Patents Act 1990 (Cth) and interest; and
  • Its costs of the proceedings.

A preliminary hearing was held on December 19, 2014, and the next hearing is set down for April, 2015.

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Call us or send us a fax..

Sydney (head) office Phone | +61 2 9552 1707
Sydney (head) office Fax | +61 2 9552 1709

Penang office Phone | +60 4 281 1371
Penang office Fax | +60 4 281 1372

   

Visit us at one of our locations..

Sydney (head) office address
235 Nelson Street, Annandale, NSW 2038 AUSTRALIA
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Penang office address
No. 2-2, Lebuh Sungai Pinang 1, Seksyen 8,
Bandar Georgetown, Daerah Timur Laut,
11600 Pulau Pinang, MALAYSIA
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E-Mail us your enquiries..

For general enquiries please contact enquiries@enersol.com.au
For Laboratory equipment and testing enquiries please contact
Lisa Henretty or Hung Truong