Stability Testing

Stability Testing

New drug substances and products

General information

Stability testing is the statistical analysis of how long a pharmaceutical product/substance can be stored without any change in its original chemical, physical, microbiological and biopharmaceutical composition.

Stability testing provides evidence on how the quality of a pharmaceutical product or substance varies with time under the influence of a variety of environmental factors such as photostability (light), temperature and humidity.

It further establishes:

  • A re-test period for the product/substance,
  • A shelf life (expiry date) for the product/substance and,
  • The recommended storage conditions for the product/substance

Types of stability testing studies

Based on the nature of the test and the estimated shelf-life periods, various stability testing methods are used to arrive at a statistical data point for a product/substance.

The four (4) widely practiced forms of stability testing are;

  • Real-time stability testing
  • Retained sample stability studies
  • Cyclic temperature stress testing
  • Accelerated stability testing

Of which real-time- and accelerated stability testing are the most common types of stability testing.

Stability testing storage conditions

The storage conditions are usually prescribed by:

  • The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH),
  • The World Health Organization (WHO) and
  • Locally by the South African Health Products Regulatory Authority (SAHPRA)

Which are a set of guidelines used to ensure high-quality, safe, and effective pharmaceutical development, as well as efficient registration.

There are several stability testing zones based on the five (5) different climate zones around the world.

 

 Long Term Stability Testing Conditions

Climatic Zone

Temperature

Humidity

Minimum Duration

Zone I

21°C ± 2°C

15% RH ± 5% RH

12 Months

Zone II

25°C ± 2°C

60% RH ± 5% RH

12 Months

Zone III

30°C ± 2°C

35% RH ± 5% RH

12 Months

Zone IVa

30°C ± 2°C

65% RH ± 5% RH

12 Months

Zone IVb

30°C ± 2°C

75% RH ± 5% RH

12 Months

Refrigerated

5°C ± 2°C

No Humidity

12 Months

Frozen

-15°C ± 2°C

No Humidity

12 Months

 

Accelerated and Intermediate Stability testing Conditions

Climatic Zone

Temperature

Humidity

Minimum Duration

Accelerated Ambient

40°C ± 2°C

75% RH ± 5% RH

6 Months

Accelerated Refrigerated

25°C ± 2°C

60% RH ± 5% RH

6 Months

Accelerated Frozen

5°C ± 3°C

No Humidity

6 Months

Intermediate

30°C ± 2°C

65% RH ± 5% RH

6 Months

 

ICH guidelines to conduct stability testing

  • Batches

The batches selected for stability testing should be the same as the ones that are reserved for distribution and the batched tested should be the same as the ones used in clinical trials and post packaging.

  • Packaging

The packaging used for testing pharmaceuticals should be the same as the ones used during clinical trials and production.

  • Test procedure

The test procedure or methodology should entail everything form efficiency, growth of microbial by-products, the formation of degradation products, the formation of crystalline by-products, the viscosity of the product/substance, formation of moisture/water and the effectiveness of the drug.

  • Storage conditions

The packaging material and the quality of the substance used while testing the product/substance should be the same as the one submitted to the regulatory bodies in the clinical trials and production phase.

Our Services

At LabSPACE Africa we offer unparalleled, stability testing at an affordable rate according to your business needs at any of the long-term, accelerated and/or intermediate stability testing conditions.

We can design, develop, and validate the analytical method(s) required for testing parameters that needs to be used during the stability study and further regulatory submissions.

We also offer sterility testing of pharmaceutical products and substances that can be customized to specific microorganism isolation according to your unique business requirements.

If you are looking for high quality and affordable stability testing solutions, contact us today.

Laboratory Setup: Frequently asked questions.

How do you setup a new laboratory?

At LabSpace Africa, we love receiving your questions and requests!

 

But quite often, great minds think alike, and we receive similar questions from readers attempting to setup new laboratories in Africa.

In this article we address some of the questions we are most often asked in the hopes of providing clarity in the muddy waters of laboratory setup in Africa.

How do you setup a new laboratory?

How do you eat an elephant? The simple answer: one bite at a time.

As with most seemingly insurmountable tasks, our best advice would be to break down the complexity of setting up a new laboratory into smaller, more manageable projects. We have compiled a condensed list of four of the most important consideration that should be made when setting up a new, highly productive, profitable laboratory:

Function

The function of your intended laboratory will largely dictate its requirements, layout and overall setup. Prepare a clear vision and mission of your laboratory that includes its intended function, size and number of staff you intend to employ.

Keep these plans handy when approaching all the subsequent decision-making steps. It will serve as the golden thread that draws the various loose ends together to setup a cohesive, productive laboratory.

Layout

Based on our collective experience at LabSPACE, we have found that the physical layout of a lab serves as the foundation on which its functionality and productivity is built. Once your lab becomes profitable, equipment and training can be improved upon, but your lab’s layout is unlikely to be changed without dramatic costs involved.

Therefore, we urge you to take your time when planning the layout of your new lab!

Your lab’s infrastructure is one of the first features to prepare for. This refers to the permanent features of your physical space.

Some features may include appropriate floor and bench top materials. It will also include features such as suitable entrances to allow for delivery and servicing of large equipment, a suitable number of accessible restrooms for staff and visitors and sufficient storage space specific to your requirements.

We also recommend keeping similar functional spaces separate.

Let’s clarify.  You should try to separate high-traffic areas from hazardous workspaces. You should plan strategic locations for large, frequently used instruments, keeping administrative and hazardous areas separate.

Once you have determined your space requirements, you should study its “functional flow”.

We recommend visualising how these spaces can come together for the most productive workflow in your allocated space. The aim of this exercise is to optimise the productivity without compromising staff safety and limiting contamination.

Equipment

As previously mentioned, we believe that no two labs are the same and lab equipment requirements are no different. Based on the main function of your lab, your list of lab equipment will be unique.

To get your equipment list off to a good start, we have compiled a condensed list of the basic equipment necessities. We discuss these in more detail in the questions to follow.

Once you have established your equipment list, make sure to compensate for storage required to accommodate your equipment and consumables. Insufficient storage could lead to a cluttered lab that makes it notoriously challenging to maintain a sterile working environment.

Safety

We urge you to never compromise on your laboratory’s safety features. Period.

Regardless of budget, your lab needs sufficient and appropriate safety measures in place to not only protect your staff and visitors, but also its instruments and resources long term.

Some basic safety features you need to consider may include:

Accredited safety training for all laboratory staff.

Bio-safety cabinets to avoid contamination.

Fire extinguishers.

Waste disposal management.

Electrical systems with appropriate wiring.

Chemically resistant work surfaces.

Safety goggles, visors, gloves, lab coats or full protective equipment.

More specialized safety measures will be necessary depending on the function of your laboratory. Furthermore, safety features should be continuously upgraded, updated, and tested to maintain your lab and its staff’s safety.

For a more detailed discussion regarding our recommended considerations when setting up a laboratory in Africa, please read the full article here.

How do you setup a medical lab?

Although the fundamental principles of setting up a medical laboratory is similar to those of any other lab (please read our answer to Question 1), it has some unique challenges.

Aside from employing qualified, appropriately accredited personnel, some of these specific challenges pertain to biosafety and specialised equipment.

Biosafety

Biosafety is defined as the necessary safety measures that must be taken when handling biological organisms or materials. Because medical labs are often responsible for handling contaminants that can be harmful to human life, biosafety should be prioritized during medical lab planning and setup.

The aim is to reduce exposure to the potentially harmful organism or material. There are two types of containment:

Primary barriers: To protect the personnel and immediate laboratory environment. These might include fume cupboards, lab coats, safety goggles and visors, to name a few.

Secondary barriers: To protect people outside the lab. Good lab design creates internal barriers preventing an organism or hazardous material from breaching containment.

Of course, not all labs will contain extremely hazardous biological materials. Most will be testing normal bodily excretions, and standard medical lab safety standards will need to be applied.

Specialised Medical Laboratory Equipment

A condensed equipment list may include:

Microscopes: Used to magnify objects like cells or tissues to detect the presence of bacteria or viral infections or to see changes in the tissue structure.

Haematology analyser: Conducts tests on blood samples, such as a blood count or coagulation test.

Urinalysis analyser: It examines the chemical constituents of urine samples, such as protein, blood, specific gravity and glucose.

Immunoassay analyser: It is used to diagnose infectious diseases, test for cancer markers, or perform cardiac analysis.

Medical autoclave: It is primarily used to sterilise surgical and pharmaceutical equipment.

What are general laboratory requirements?

When explaining the basics of laboratory setup (Question1), we discuss the importance of establishing the main function of your lab, before planning its layout and requirements. Therefore, no two labs will have the exact same requirements.

To guide you towards compiling your lab’s unique requirement list, we have prepared a list of considerations to include:

Infrastructure: Permanent features such as bench tops, floor surfaces, entrances, and storage spaces.

Equipment: Basic, general laboratory equipment (discussed in more detail below) and highly specialised instruments to support your specific industry.

Consumables: Plastic petri-dishes, pipet tips, needles, tissue paper, surgical gloves and function-specific products that will require consistent re-ordering.

Quality Management System (QMS): A collection of policies and procedures a laboratory must comply with to ensure delivery of standardized, consistent, high-quality services and products to customers according to international standards. Examples of appropriate QMS systems for laboratories include ISO/IEC17025, ISO/IEC15189 or ISO/IEC13485 to name only a few.

Safety features: Biosafety cabinets, waste disposal systems, goggles, lab coats, fire extinguishers.

Personnel training: Skills training for specific analyses, first aid and safety training.

What is the equipment used in a laboratory?

When setting up laboratories in Africa, procuring equipment isn’t always simple. While items like glassware, fire extinguishers, and other basic equipment are easy to come by, some specialised equipment may be harder to purchase.

Although the equipment requirements of every lab will be unique, we have compiled a condensed list of the basics that you might find useful when compiling your own lab equipment checklist:

Glassware: Beakers, Erlenmeyer flasks, Florence flasks, volumetric flasks, pipettes, graduated cylinders, test tubes.

Micropipette: To accurately transfer pre-determined measures of liquid in the microlitre volume range.

Thermometer: A device that measures the temperature of a substance.

pH metre: A device that indicated the acidity or alkalinity of a water-based substance, based on its hydrogen-ion activity.

Fume hood: A localized ventilation workstation device that limits exposure of hazardous chemicals, cultures, and other substances to the surrounding environment.

Centrifuge: A device that separates various components of a fluid through centrifugal force.

Microwave: Used to heat materials and liquids in the preparation of growth media and other solutions.

Microscope (light or electron): An instrument used to observe small objects otherwise invisible to the naked eye.

Spectrophotometer: An instrument that determines the chemical structure and/or concentration of compounds in a solution.

Bunsen burner: including wire gauze and tripods

Magnetic stirrers: A tool used to effectively mix liquids using a stirrer bar that rotates in solution through a rotating magnetic field.

Weighing scales: An instrument used to determine the weight or mass of a compound, powder, or liquid.

The more specialised equipment your lab may require will depend heavily on the function of your lab.

Conclusion

We hope we have addressed some of your most pressing issues, but if you are left with more burning questions, we recommend reading our recent blog post “Setting up laboratories in Africa: Where to Start” for more detailed information on the topic.

More questions for us? Please reach out!

Our highly experienced team is standing by to provide some expert insights into effective laboratory setup, specific to your needs.

Written by: Kari Du Plessis

 

Please contact us for more information on how we can customise our services to your needs.

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