How Long Does Sterility Testing Take?


Due to the increasing demand for pharmaceutical
products, many companies are investing in gadgets and equipment that can help
them ensure that the products manufactured are of top quality and have a
positive effect on the people who interact with them.

Amongst all this, it is imperative to have sterility testing of pharmaceutical products to ensure no
contamination exists.

Why a Sterility
test?

Sterility
testing of pharmaceutical products is a process where, with sterilization
validation and quality control, any false-positive results can be eliminated,
which is nothing but human error or even contamination from the laboratory.

These errors or contaminations are easy to mix
with the pharma products, and it is essential to make sure they are eliminated
before it reaches the consumer market.

  • Sterility testing of pharmaceutical products, especially
    those labeled as “Sterile”, should occur without any compromise, as
    per the standards set by International pharmacopeia.
  • These tests are
    necessary as they reveal any bacteria, yeast, or fungi present in the products
    that show the presence of moisture or an environment fit to be a breeding
    ground for all of them.

Duration of a
Sterility test:

  • Any product
    that will reach a consumer or a patient in a hospital should be sterile enough
    such that it does not affect their lives. Every pharma company has to ensure
    the safety and health of the patient.
  • The duration of
    the sterility testing of
    pharmaceutical products lasts about 14 days. Still, the new technology
    and advanced machinery introduced in the market are speeding up the process,
    making them last for only seven days or so.
  • The tested
    products can not be released into the market until it meets the QC (Quality
    Control) standards of sanitation and
    sterilization. Sterilization methods such as Rapid Microbial
    Methods (RMM) are helping to speed up the process of testing by a week and
    adhere to the pharmaceutical industry’s stringent requirements.
  • The initial
    results of specific rapid sterilization tests are so quick that they come
    within an hour (24 hour testing time).
  • The technology
    today is so advanced that it helps companies save a lot of time to get their
    goods into the market by saving time from 14 days up to 21 days, which was
    traditionally taken up for testing.

Standard
methods of Sterilization testing:

There are two standard testing methods used to
test for sterility:

  • Membrane Filtration Method: This method has
    seen to gain a lot of global recognition to overcome and circumvent the
    activity of antibiotics. This technique or testing is performed usually by
    highly skilled people who have in-depth knowledge about the process.
  • Direct Inoculation Method: In this method,
    three mediums are used to test the sterility – a nutrient broth, Sabouraud
    medium, cooked meat medium, and thioglycollate medium. This test is usually
    used to test pharma products such as ointments, etc.

How to choose
labs that provide this service:

There are a lot of analytical and testing labs
today that clients find difficult to choose from them. They all have excellent
facilities and new technology to cater to their needs, but an important thing
to look into is their values, what they believe in, what they want to deliver
to their client. Following are a few values and vision that should certainly be
looked into:

  • They should
    have the zeal and drive to care for quality and to cure all people of any
    illness.
  • They should
    certainly not compromise on the quality of testing or services they provide.
  • Their equipment
    and labs must be certified, and these certifications should be valid and not
    have passed their expiration dates.
  • They should
    constantly keep upgrading their resources and knowledge and encourage their
    team to continually upgrade their skills, keeping up with the growing industry
    standards.
  • Not only
    catering to the clients, but the focus of the lab service should also be to
    save the environment. They should be sustainable, reasonable with their working
    processes such that they come up with very little to no pollutants.
  • A significant
    factor in seeking is transparency. The clients must do their thorough research
    and understand if the lab is known for its transparent operations and interaction
    with their past clients. It is always advised to go through the reviews.
  • To see what
    their reach is if they are locally catering to clients, or even
    internationally. It will showcase how outgoing they are.

To conclude, sterilization techniques have made
such an advancement in the pharmaceutical field. At a bare minimum, pharma
companies incorporate these basic protocols to be followed to ensure their
customers’ safety at every step.

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