This is the presentation about pharmaceutical packages and their various stability testing's ,climatic cabinets as per ICH, FDA Regulations, Protocols, Objectives,& Purpose.

1. THIRD YEAR B.PHARMACY
IDEAL COLLEGE OF PHARMACY AND
RESEARCH KALYAN(BHAL)-
THANE,MAHARASHTRA.

2.  INTRODUCTION
 OBJECTIVES
 PROTOCOLS
 REGULATORY ASPECTS OF PHARMACEUTICAL PACKAGING(as per
FDA) AND ITS PURPOSE
 WHAT IS ICH & REGULATIONS
 PHARMACEUTICAL STABILITY TESTING IN CLIMATIC CABINETS
 PHARMACEUTICAL STABILITY TESTINGS

3.  Stability Testing of Pharmaceutical Packages are defined as ”the capability of package material
on how it varies with time under the influence of a variety of environmental conditions such as
‘temperature’ , ‘humidity’, and ‘light’with a formulation product and to remain within its
chemical ,physical ,microbiological , therapeutic & toxicological specification throughout its
shelf life”.
• AIM:
 Interaction between active ingredients and excipients , manufacturing process followed , type of
dosage form, container/ closure system used for packaging.
 Light, heat, moisture conditions encountered during shipment storage and handling.

4.  To gather information during pre-formulation stage to a stable product.
 To determine maximum expiration date.
 To get an idea of storage conditions.
 To determine the packaging of components.
 To establish the retest period of pharmaceuticals.
 To establish a transport condition.

6.  The protocol for stability testing is a pre-requisite for starting stability testing and is necessarily
a written document that describes the key components of a regulated and well-controlled
stability study.
 A well designed stability protocol should contain the following information:
 Number of Batches
 Containers and Closures
 Orientation of Storage of Containers
 Sampling time points
 Test storage conditions
 Test Parameters
 Test methodology
 Acceptance criteria .

7. • FDA plays a major role in the approval of manufacturing materials used in packaging materials
and also publishes the list of materials which are generally considered as safe (GRAS).
• Regulatory specifications are the defined limits( e.g :-physical, chemical, biological, micro
biological) within which test results for a substance or drug product.
• The regulatory tests and specifications should be designed to ensure that the dosage will meet
acceptable therapeutic & physiochemical standards through out the shelf life of the marketed
product.
• Regulatory specifications includes all criteria that apply to the bulk dosage form, those related to
the packaged product, & those that indicate the presence or absence of degradation.

8. • When alternative analytical methods that are equivalent to, or that are an
improvement over, the compendial(IP methods) are submitted to the agency, the
applicant is encouraged to simultaneously ask the (USPC) to change or modify
the methodology in the monograph.
• Assay and identity specifications using a well characterized reference standard
and description of physical characteristics are required.

9. • To submitting documents for packaging for human drugs and biological, the
followings are required….
• Package must maintain standards, identity, strength, quality and purity of drug
for intended shelf life.
• Full information needed.
• Type of container or closure.
• Suitable for intended use.
• Submission of packaging information and date.

10. • “International conference of Harmonization” involving both regulators and research based
industry representatives of respective countries in scientific and technical discussion of testing
procedures required to assess and ensure the “safety”, “quality” , and “efficacy” of medicines.
• REGULATION:
• The ICH (International conference on Harmonization) Recommends that “Stability testing of
new drugs and products” is the “Gold Standard” for conducting stability studies.
• This is valid for “New Drug Substances or Drug Products” that are sufficient for a registration
application.

13. • Types:
• Accelerated:
Studies designed to know the shorten excursions of temperature on the drug substances.
• Intermediate:
Studies conducted, in case of failure in accelerated studies and the conditions of temperature and
humidity are in between long term and accelerated.
• Long term:
Studies designed to check the instability of the drug substance.

14.  Compression Strength Testing: packages behave differently when exposed to compressive forces . It uses
testing capabilities to apply compressive forces to packages and products and provide a comprehensive
report with data on strength of package .
 Distribution Simulation Testing : packages experience many different forces during the shipping and
distribution process . It is the products manufacturer’s responsibility to evaluate and document the ability
of the package to withstand the distribution and storage environment.
 Package Integrity Testing: It uses established tests to test the integrity of pharmaceutical package . Such
tests include dye leak , visual inspection , vacuum leak and Bubble leak testing to inspect the package’s
integrity capabilities.
 Package Strength Testing: package strength testing is conducted to measure and ensure that the
components of packaging will not separate when specific forces are applied . The testing of flexible
components such as pouches , seal peel, or burst testing are methods used to prove the packages strength .
 Vibration testing: packages and products experience wide range of Dynamic forces and stresses during
distribution that could harm a product. It performs vibration tests on samples to stimulate the stresses and
forces a package/product would experience during distribution process.
 Shock and Vibe testing: Dropping , rotational edge dropping, and rotational flat dropping tests to
stimulate the real world exposure of package to shock forces by fork lifts, package handling or other
factors in the pharmaceutical package’s distribution cycle.