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Chilli ill (Asia Pacific Pleasuremax Warming) Project number 441

Wadee Kanphai confirmed that the artwork for Chilli III had been received.

There was then some discussion about the testing of the Chilli III condoms for the stability

programme.

It was agreed that Thailand would undertake the water leak testing on three batches.

Action: Andrew Brownhill to send 500 pieces of each batch to Thailand for water leak

testing.

The burst testing (initial and aged) and the tensile testing and pack integrity is to be carried

out in Cambridge.

Action: Ian Love to follow up the testing

The current plan for sample testing is as follows:

Initial testing: 500 water leak 315 burst 13 tensile 50 pack integrity 6 microbiological testing

7 days at 7O’C 315 burst 13 tensile 12 pack integrity

28 days at 7O‘’C 125 burst 13 tensile

1 month at 30 and 50°C 125 burst 13 tensile

3 months at 50°C 315 burst 13 tensile 12 pack integrity

3 months at 3O'’C 125 burst 13 tensile 12 pack integrity

6 months at 30 and 5O’C 125 burst 13 tensile 12 pack integrity

12 months at 30 and 50°C 125 burst 13 tensile 12 pack integrity

24.36 and 48 months at 3O’C 125 burst and 13 tensile

60 months at 30°C 315 burst 13 tensile 32 pack integrity and 6 microbiological testing

There was a discussion on the testing regimes and some discrepancies on the level of

testing for ISO 4074, SOP/G/200 and the samples tested in Cambridge were apparent.

Action: Wadee Kanphai to forward testing regimes used for IS04074:2002, SOP/G/200

and those currently used in Cambridge/Thailand

Chilli III will be registered according to ISO 4074:1996 for the Hong Kong launch in July.

Action: Wadee Kanphai to confirm if Thai FDA requires additional documentation to

support the registration, which could potentially lead to delays.