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Physical Concern

Physical criteria: Does the device have physical characteristics that vary with time (appearance. elasticity. tensile strength ...) that may cause concern to the user?

Manufacturing process: Do the different steps in the manufacture of the device affect the physical characteristics of the individual components or the finished device in a manner which adversely affects the device safety or performance?

Storage conditions: Do the storage conditions (temperature, humidity ...) have an effect on the device in a manner which adversely affects device safety or performances?

Chemical Concern

Degradation: Do any active ingredients or components of the device degrade over time in a manner which adversely affects device safety or performance?

Interaction: Do ingredients or components interact to alter the device? Does the device have interactions among the various components that cause degradation of the ability to perform the intended function?

Device and packaging interaction: Is there interaction between the device and package that has undesirable effects?

Manufacturing process: Do any of the manufacturing processes alter the chemistry of the raw materials, components or finished device in a manner which adversely affects the device safety or performance?

Microbiological Concern

Sterility: Do sterile devices remain sterile? Maintenance of sterility is primarily determined by the maintenance of package and seal integrity.

Environment control: Is an environmental control program needed during' manufacturing or storage to monitor and adjust the microbial load in or on the device and packaging below an established tolerance level to prevent adverse degradation of the product?

Integrity: Do the device's barrier characteristics change?

We work on-

Real Time Stability Study

Accelerated Stability Study (ASTM F1980-16)-



Equations:

Step1: AAR = Q 10 (AAT-AT)/10)

Step 2: AATD = DRTA/AAR


Example:


Time Duration calculation for accelerated ageing of medical devices. One Year shelf study at 60 0 C, where ambient temperature is 35 0 C and Q 10 = 2.
Steps Equation Sample Data
Ste1 AAR = (AAT-AT)/10) AAR = Q10 (60 - 35)/10)
= 5.65
Step2 AATD = DRTA/AAR Where,
DRTA = 365 X 5 =1825 Days		 AATD =1825/5.65
= 323 Days.

AA = Accelerated Ageing: Storage of samples at a high temperature (T AA) so as to stimulate Ageing in real time in a reduced length of time.

AAR = Accelerated Ageing Rate: Proportional factor to the estimated or calculated time so as to reach the same level of change of physical property as on a packaging stored in some conditions in real time RT (Real Time).

AAT = Accelerated Ageing Temperature: Temperature at which the study of accelerated ageing is conducted and which can be based on an estimation of the storage temperature or an estimation of the temperature of use or both.

AATD = Accelerated Ageing Time Duration: Time during which the accelerated ageing is performed.

AT = Ambient Temperature = Real Time Temperature: Storage temperature of samples used for ageing in real time

Package shelf life: Time during which a packaging can be stored at ambient temperature or in lower storage conditions and keeps all its properties.

DRTA = Desired Real Time Ageing: Storage time of samples at- ambient temperature

RTE = Real Time Equivalent: Real time equivalent to accelerated ageing conditions to = beginning of the ageing study

Q10 = Ageing factor corresponding to an increase or decrease of temperature by 10°C