Safety Testing

SAFETY TESTING

In Vivo
Testing

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In Vitro
Testing / Ex Vivo

CLAIMS

MICROBIOLOGICAL CONTROL

According to ISO 21149

According to Ph. Eur. (European Pharmacopoeia)

STABILITY TEST

Stability screening (15 days approx.)

Temperature cycling

Mechanical shock testing

Light stability testing

 

Accelerated stability studies (3/6/9 months)

Conditions:

40 °C / 75 % RH

Customer specific requirements

Parameters:

Organoleptic characteristics

Physico-chemical characteristics

Microbiological control

 

Period after opening (PAO) determination

 

Long term stability studies (real time)

Parameters:

Organoleptic characteristics

Physico-chemical characteristics

Microbiological control

 

Container–content compatibility studies

According to the packaging material

CHALLENGE TEST

Challenge test (PET- Preservative Efficacy Test):

  • According to ISO 11930:2012
  • According to European Pharmacopoeia (Ph. Eur.)
  • According to United States Pharmacopoeia (USP)

PATCH-TEST

  • Patch Test: 24 or 48 hrs
    • Panel size: 10, 20, 30 or 50 panelists
    • All skin types or sensitive skin only
    • Occlusive or semi-occlusive
    • Measures primary irritation/inflammation potential
    • Always Dermatologist supervised
  • Strip-Patch Test
  • Photo-Patch Test

HRIPT (RIPT)

HRIPT (RIPT):

  • 50 panelists  (all skin types)
  • 50 panelists (sensitive skin only)
  • 100 panelists (all skin types)
  • 150 panelists (all skin types)
  • Always Dermatologist supervised

OPEN-TEST (ROAT – REPEATED OPEN APPLICATION TEST)

Panel size: 10/20/30/50 panelists

Application at Research Center:

  • 1 application (1 unique application)
  • 3 applications (application every other day)
  • 5 applications (application on each consecutive day)

    Medical supervisions:

  • Dermatologist
  • Ophthalmologist
  • Odontologist 
  • Gynecologist 

IN-USE (AT HOME) STUDIES

  • Duration of the study: 7/14/21/28 days

  • Panel size: 20/30/50 panelists

  • Panel type:

    • Mixed (All genders)

    • Women only

    • Men only

    • Babies and kids

    • Babies or kids only

    • Specific demographics (Women 18-25 only)

    • Specific ethnicity or multi-ethnic

      Medical supervisions:

      • Dermatologist
      • Ophthalmologist
      • Odontologist 
      • Gynecologist 

     

CONSUMER STUDIES

  • Duration of the study: 7/14/21/28 days

  • Panel size: 50/100/150 panelists

  • Panel type:

    • Mixed (All genders)

    • Women only

    • Men only

    • Babies and kids

    • Babies or kids only

    • Specific demographics (Women 18-25 only)

    • Specific ethnicity or multi-ethnic

    • Low/Mid/High end products
    • All distribution channels (pharmacy, mass-market, etc.)