Stability Studies — Pharma, Medical Device and Cosmetic Industries

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Ways we test and study the stability of your product/package/or materials:

Temperature and Humidity Testing

Temperature and humidity testing evaluates the effects of these conditions on products or materials. When subjected to harsh environments or extreme temperatures, the quality and reliability of the product can become compromised. Using environmental chambers, extreme temperature changes, pressure changes, and changes in humidity are replicated to record product performance and measure resistance. We test:

  • Altitude
  • Humidity Exposure
  • Temperature-Lifecycle
  • Thermal Shock

Stability Storage Solutions (Bio-Storage)

Quality biological products require reliable biomaterials and stability storage studies – this means guaranteeing that the integrity of your materials stays consistent through every testing stage. As part of our dedication to promoting quality storage testing for biological products, Purple Diamond provides researchers with cGMP-compliant biorepository laboratories that deliver safe, reliable storage and management of your packaged biological products.

Purple Diamond can securely store your biological items to custom conditions. Our stability storage chambers are designed to store and protect your biological materials, clinical trial materials, pharmaceuticals, vaccines, and more. Storage ranges for biological materials begin at Room Temperature 15C – 27C, Refrigerated Storage 2C-5C, Freezer Storage -20C, and finish at Ultra Low Freezer -80C.

Biological Storage Services Include:

  • Clinical Trials
  • ICH Stability Storage
  • Medical Device
  • Package Integrity Testing
  • Pallet Testing
  • Shipping Lane Studies
  • Vaccine Storage

Pharmaceutical Storage

Stability evaluations allow critical advancements in product stability to be applied to drug products or medical substances subjugated to compromising environmental factors, including temperature, light, and humidity. Data from these studies help produce quality storage conditions and establish product life cycles. Stability testing for pharmaceuticals ensures the quality, efficacy, and safety in the development of drugs, medicines, and controlled substances produced are maintained to meet the highest standards.

Purple Diamond adheres to the ICH Harmonized Guideline set forth by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline extends to new formulations of already approved medicines and details the circumstances under which reduced stability data can be considered acceptable.

Pharmaceutical Storage Services Include:

  • Accelerated Test Programs
  • ICH Stability Storage
  • Client Specific Storage Conditions

ICH Stability Storage

Stability Storage is part of a validation study to evaluate a collection of test samples placed into environmentally controlled chambers in order to determine how the quality of that product varies with time under environmental conditions such as temperature, light, and humidity. Samples are observed and retrieved at varying storage lengths to determine if any changes to physical, chemical, or microbiological makeup have occurred. Data collected during the study can then be used to define the maximum length of time the will be able to maintain its integrity and predict what product changes can occur over time with exposure to specific environmental stressors.

Cosmetics Storage

Stability storage studies for cosmetic goods deliver critical insights used to define the optimal shelf life for cosmetic products within ASTM standards. Evaluating stability and determining the shelf life of a cosmetic product can be achieved by monitoring changes in the integrity and quality of its composition or material makeup over time. Stability and product integrity of cosmetic goods can be affected by major factors including storage variation, ingredient quality, and processing aids, as well as the type of and quality of packaging used.

Purple Diamond’s certified laboratories are equipped to perform testing on all types of cosmetic items, regardless of whether those products are considered to be of natural, organic, or synthetic makeup.

Biological & Pharma Storage – *Exposure and Storage Services and Research Storage*

  • Vaccine Storage
  • Clinical Trials
  • Medical Device
  • Shipping Lane Studies
  • Packaging/Pallet Testing
  • Custom

Cold Chain Logistics *Exposure/Storage Services for Temp Controlled Supply Chains*

Cold Chain Validation is achieved under thoroughly controlled conditions and ultimately confirms that a process delivers results that meet a predetermined set of acceptance criteria. There are two key critical variables involved in heat transfer that should be considered when designing cold chain packaging: time and temperature differential. In any particular distribution process, if there is exercised control over both the length of transit and the external temperature of the distribution environment, cold chain validation would be dependent upon the specific product requirements and the thermal technology used.

How We Validate Cold Chain Packaging

Cold Chain Package Testing

Cold chain related packaging is a critical variable in validation. Thermal transport packaging, for instance, must be capable of holding a product temperature through the entire length of the distribution cycle. For example, refrigerated pharmaceuticals and biologics that require temperature control, shipped in an insulated shipping kit, may be monitored using temperature indicators and trackers to collect data during transit and then assessed accordingly.

  • ASTM D3103 – Test Method for Thermal Insulation Performance of Distribution Packages
  • ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems
  • ASTM D4332 – Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
  • ISTA 7D – Temperature Test for Transport Packaging
  • ISTA 7E – Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment

Thermal Mapping

An extension of the Good Manufacturing Practice (GMP) environment, thermal mapping evaluates the packaging system used to distribute and ship temperature sensitive products. This type of testing assesses the packaging’s ability to maintain the stability of its contained product within the required conditions. Thermal mapping may be used in conjunction with additional cold chain testing and distribution simulation tests.

Accelerated Aging Testing

  • ASTM G154 – Practice for Operating Fluorescent Ultraviolet (UV) Lamp Apparatus for Exposure of Nonmetallic Materials
  • ASTM G155 – Practice for Operating Xenon Arc Lamp Apparatus for Exposure of Materials
 

Packaging and Engineering Consultations are provided to you by Purple Diamond Packaging – Test | Design | Engineer

Request a comprehensive consultation here: https://purple-diamond.com/contact-us/

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