Training for Book Authors
|
|
Other Resources for Book Authors & Publishers
|
|
Please Support Our Advertisers
|
|
|
|
|
Options for Container and Closure Systems Sterility Testing
Copyright (c) 2008-2023 Norm Howe
While sterility testing can be cumbersome and time consuming, there are FDA-approved options regarding container and closure system integrity testing. In fact, the Food and Drug Administration (FDA) recently released a guidance document on container and closure system integrity testing in lieu of sterility testing as a component of the Stability Protocol for Sterile Products. The document offers an alternative approach, if the approach satisfies the requirements of the applicable statutes and regulations.
Aimed at manufacturers, the guidance offers alternative testing methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices.
The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Products labeled as sterile are expected to be free from viable microbial contamination throughout the product's entire shelf life or dating period. This enables manufacturers to establish or modify recommended storage conditions, retest periods and shelf life or dating period, as the case may be.
Currently, manufacturers of drugs and biologics purporting to be sterile are required to test each batch or lot, to ensure that the product in question conforms to sterility requirements. They must also maintain a written testing program designed to assess stability characteristics and meet stability testing requirements.
Manufacturers of medical devices are required to validate processes, including sterilization, for a device purporting to be sterile, although stability testing should be part of the design validation of such devices. Also, in vitro diagnostic products for human use are required to be labeled with stability information.
The minimum sterility testing generally performed as a component of the stability protocol for sterile products is at the initial time point (release) and final testing interval (i.e., expiration). Additional testing is often performed at appropriate intervals within this time period (e.g., annually).
Alternatives to sterility testing as part of the stability protocol, such as replacing the sterility test with container and closure system integrity testing, might include any properly validated physical or chemical container and closure system integrity test (e.g., bubble tests, pressure/vacuum decay, trace gas permeation/leak tests, dye penetration tests, seal force or electrical conductivity and capacitance tests, etc.), or microbiological container and closure system integrity tests (e.g., microbial challenge or immersion tests).
Such tests may be more useful than sterility testing in demonstrating the potential for product contamination over the product's shelf life or dating period. The advantages of using such container and closure system integrity tests in lieu of sterility tests in the stability protocol for sterile products include: detecting a breach of the container and/or closure system prior to product contamination; conserving samples that may be used for other stability tests; requiring less time than sterility test methods which require at least seven days incubation; and reducing false positive results with some alternative test methods when compared to sterility tests.
To implement container and closure system integrity testing as an alternative to sterility testing, the FDA recommends manufacturers consider the following: a container and closure system integrity test may replace sterility testing in a stability program at time points other than the product sterility test prior to release; container and closure system integrity tests do not replace sterility testing methods for product sterility testing prior to release; any validated container and closure system integrity test method should be acceptable provided the method uses analytical detection techniques appropriate to the method and is compatible with the specific product being tested.
The guidance document, as well as alternative testing options, can be difficult to understand. For more about the content of the guidance, contact CBER's Office of Compliance and Biologics Quality at 301-827-3031; CDER's Office of Pharmaceutical Science at 301-796-1228; CDRH's Office of Device Evaluation at 240-276-3747; or CVM's Office of New Animal Drug Evaluation at 301-827-6963.
Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com
|
VOTE ON THIS ARTICLE
Needs Work >>
0 -
1 -
2 -
3 -
4 -
5
<< Excellent Article
Tell our authors what you think about their article.
|
Top-Level Category: Health and Wellness Articles || Related Categories: Food and Drink Articles
10 Most Recent Articles Written by Norm Howe
Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit
Written by: Norm Howe |
Distributed: 2011-09-12 |
Word Count: 706 |
Page Views: 537
Medical device manufacturers are always interested in knowing
what FDA's next area of focus will be. Well, if you're an In
Vitro Diagnostic manufacturer you might review your measurement
systems.
How to Evaluate the Quality of a Dietary Supplement
Written by: Norm Howe |
Distributed: 2010-11-02 |
Word Count: 751 |
Page Views: 5410
| Votes: 7 |
Rating: 0.57
So, you've found a Dietary Supplement that exactly fits
your special need. The information on the supplier's
website appears to be consistent with everything that
you've read and heard, and now you're ready to buy. But
there are questions on your mind. "What is the quality of
this product that I'm buying?" you ask. "Can I really
trust this supplier?"
Off-Label Use of Medical Devices
Written by: Norm Howe |
Distributed: 2010-06-22 |
Word Count: 621 |
Page Views: 6064
| Votes: 3 |
Rating: 1.67
How can a medical practitioner decide whether a medical device
that they want to use for one of their patients is legal and
approved by the Food and Drug Administration? When a patient
comes into a physician's office the patient is looking for the
best, most modern care they can get. And a physician certainly
wants the same thing.
A New Paradigm to Address the High Cost of Vendor Qualification
Written by: Norm Howe |
Distributed: 2010-01-12 |
Word Count: 1160 |
Page Views: 4496
| Votes: 6 |
Rating: 1.17
The assumption today is that a BETTER audit means a LONGER
audit. There has to be another way. What's needed is a new
paradigm for vendor qualification; a tool that can drill
deeply into the vendor's operation at low cost; something
that can provide a more lasting measure of the vendor's
performance than simply an audit...
FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe |
Distributed: 2009-03-10 |
Word Count: 666 |
Page Views: 5306
| Votes: 9 |
Rating: 0.67
The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track?
The Myth of the Generic SOP
Written by: Norm Howe |
Distributed: 2009-03-03 |
Word Count: 687 |
Page Views: 4881
| Votes: 8 |
Rating: 2.00
What do you do when your boss tells you to write an SOP? Run and
hide? Tell her how long it will really take to write one that's
any good? If you choose the latter option, be prepared for this
"helpful suggestion": "Why don't you just download a generic
SOP from the internet?" You would have been better off taking
the former option. Here's why.
The Evolution of Process Validation
Written by: Norm Howe |
Distributed: 2009-01-27 |
Word Count: 471 |
Page Views: 6666
| Votes: 15 |
Rating: 1.53
In November 2008, the U.S. Food and Drug Administration (FDA)
published draft guidance on process validation. Entitled Process
Validation: General Principles and Practices, this draft guidance
replaces the previous guidance issued in 1987. What does this
mean to you?
FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe |
Distributed: 2009-01-21 |
Word Count: 665 |
Page Views: 6491
| Votes: 9 |
Rating: 2.78
The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track?
Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers
Written by: Norm Howe |
Distributed: 2009-01-05 |
Word Count: 440 |
Page Views: 4487
| Votes: 8 |
Rating: 1.38
How do small Dietary Supplement manufacturers comply with the new
Dietary Supplement GMPs? The U.S. Food and Drug Administration
(FDA) announced plans to publish a compliance guide that will
provide assistance to small dietary supplement manufacturers.
Dietary Supplements Must Be Tested by Scientifically Valid Methods
Written by: Norm Howe |
Distributed: 2008-09-03 |
Word Count: 424 |
Page Views: 5553
| Votes: 8 |
Rating: 0.88
Are you a Dietary Supplement manufacturer trying to figure out
what FDA means by "Scientifically Valid Method"? Here are some
hints.
All of Author's Articles on this site: Norm Howe Articles
Most Recent "Health And Wellness" Articles
The Powerful Antioxidant You Cannot Eat Or Drink
Written by: Nate Rifkin |
Distributed: 2011-07-20 |
Word Count: 499 |
Page Views: 4415
| Votes: 1 |
Rating: 1.00
There's no need to eat or drink anything to activate your
body's powerful antioxidant to prevent free radical damage.
You'll end up healthier inside and looking better on the outside
as well.
3 Bacterial Vaginosis Remedies You Can Start Using Today
Written by: Louise Endago |
Distributed: 2011-07-20 |
Word Count: 867 |
Page Views: 7851
| Votes: 5 |
Rating: 1.20
Very few women are successful at treating bacterial
vaginosis using one treatment alone. The secret lies in
using a combination of treatments that complement one
another. In this article you will discover 3 such remedies
that give excellent results.
Encouraging Healthy Children with Outdoor Play Sets and Activities
Written by: Giana Briggs |
Distributed: 2011-03-17 |
Word Count: 410 |
Page Views: 6752
| Votes: 5 |
Rating: 0.40
Having a play set in your backyard can be a great way to get
your child off the couch and out into the fresh air. With
childhood obesity on the rise, we need to do what we can as
parents to get our children active and enjoying playing and
interacting with each other children again. Being able to go
out in the yard and have something to do is just one small
step in the right direction.
How to Recognize Anxiety in Children and Adolescents
Written by: Dr Jeannette Kavanagh |
Distributed: 2010-12-28 |
Word Count: 836 |
Page Views: 7037
| Votes: 4 |
Rating: 1.00
Problems with a too-high level anxiety can start in
childhood with children and adolescents worrying to a
greater extent than their peers about all sorts of things.
Some behaviors are an indication of a fussy and over tidy
child. When we go just a little bit over fussiness and we
have entered the realm of an anxiety disorder.
How to Tell if You Have Anxiety Disorder
Written by: Dr Jeannette Kavanagh |
Distributed: 2010-12-23 |
Word Count: 1093 |
Page Views: 7051
| Votes: 5 |
Rating: 1.20
If you're someone who can never earn enough or have enough
money to relax about it, and to enjoy spending it, you may
have underlying anxiety problems that you haven't had to
face, or you haven't wanted to face.
How to Tell the Difference Between Anxiety and Normal Worry
Written by: Dr Jeannette Kavanagh |
Distributed: 2010-12-21 |
Word Count: 979 |
Page Views: 6571
| Votes: 5 |
Rating: 0.40
Anxiety is a normal feeling people experience when faced
with threat, danger or stress. Feeling anxious can sometimes
be a good thing. Occasional anxiety is part of normal life.
However, for some people anxiety is a constant factor in
their lives. When a person has anxiety problems, it
interferes with their ability to function normally on a
daily basis. Anxiety disorder can cause people to feel
intense, long-lasting fear or worry, in addition to other
symptoms.
How to Treat Your Anxiety and Panic Attacks
Written by: Dr Jeannette Kavanagh |
Distributed: 2010-12-16 |
Word Count: 742 |
Page Views: 6624
| Votes: 7 |
Rating: 0.86
Next to Depression, one of the most common disorders which
affects an estimated 2.4 million people in America alone, is
anxiety disorder. Anxiety can manifest as a generalized
anxiety, panic attacks, social anxiety and agoraphobia.
Anxiety disorder can be mild or so totally disabling that
the person is confined to her or his home. All forms of
anxiety can be extremely frightening to those who experience
it frequently, but many individuals have found comfort in
the fact that anxiety disorders can be treated.
Anxiety Disorder and Panic Attacks: How Cognitive Behavior Therapy Can Help You
Written by: Dr Jeannette Kavanagh |
Distributed: 2010-12-09 |
Word Count: 748 |
Page Views: 6716
| Votes: 4 |
Rating: 0.25
In your journey to conquer anxiety and to eliminate panic
attacks from your day-to-day life, no one approach will be
totally right, but Cognitive Behavior Therapy can be a very
powerful part of your recovery. In this short article, I
want to explore what's involved in Cognitive Behavior
Therapy, so that you can make a decision whether or not
you'd like to explore it with your therapist.
Losing Weight - The Addiction of Comfort Food
Written by: Larry Tobin |
Distributed: 2010-11-04 |
Word Count: 863 |
Page Views: 6400
| Votes: 3 |
Rating: 0.00
Its very name is appealing - comfort food. What could be
more wonderful than a food that helps us feel better? Almost
everyone can name something that they eat when they're just
feeling sour or sad. Of course, we know that food can't be
the solution to our problems, especially the problem of
trying to lose weight and keep it off. So why do we find
ourselves trapped in the eat/feel better/feel worse/eat some
more cycle?
Understanding the Roles of Respite Caregivers for Seniors
Written by: Bob Fischer |
Distributed: 2010-11-02 |
Word Count: 582 |
Page Views: 5241
| Votes: 3 |
Rating: 0.67
Caregivers for seniors are typically paid providers but they
may also be volunteers from a government or nonprofit
organization. Where care is being provided in the home there
is often a mix of formal and informal care provided. And the
trend is towards using more formal care since, unlike the
past, more informal respite caregivers are employed. Read
on.
Most Viewed "Health And Wellness" Articles
Bone Density and Your Well Being
Written by: Kamau Austin |
Distributed: 2006-06-15 |
Word Count: 685 |
Page Views: 51689
| Votes: 47 |
Rating: 2.55
We spend a lot of time and energy thinking of ways to reduce our
weight but we need to think about the bones that form the basic
structure of the very same body. Bone density is an important
factor in helping us stay young and on our toes. Bone density
needs to be checked as we age and if found low, adequate measures
need to be taken to improve it.
President Given the Cure for Herpes and Cold Sores ?
Written by: James Kaylon McIntyre |
Distributed: 2006-11-09 |
Word Count: 404 |
Page Views: 33420
| Votes: 25 |
Rating: 2.24
Viraway was founded by a man who is in his 70s today. As a Young
man he suffered from acute cold sores. The discomfort was so
severe that he thought they would never go away. A native
American Indian gave him a tribal mixture of herbs and told him
that this mixture would eliminate the cold sores with in two
weeks...
Oyster Extract Improves Men's Sexual Health
Written by: Stephen Kavanagh |
Distributed: 2008-06-26 |
Word Count: 851 |
Page Views: 28655
| Votes: 61 |
Rating: 3.41
Description of the benefits of taking oyster extract powder for
good sexual health in men and women. Details of the features and
benefits, the different brands, the alternatives and advice on
choosing the right oyster extract product.
How to Force Your Body To Melt Fat Like Butter In A Microwave
Written by: Robert Kokoska |
Distributed: 2008-04-08 |
Word Count: 613 |
Page Views: 22808
| Votes: 37 |
Rating: 2.62
There are a couple of very simple changes you can make to the way
you eat that will force your body to become a fat burning furnace
and cause you to easily drop your unwanted pounds day after day.
Losing Weight Without Gaining Stretch Marks
Written by: Kamau Austin |
Distributed: 2006-12-11 |
Word Count: 579 |
Page Views: 22029
| Votes: 47 |
Rating: 2.70
Few things can make us as elated as seeing the pounds melt way
through our efforts of eating less and exercising more. We gain
new confidence and vitality as we watch our waistlines reappear
and become reacquainted with the tops of our feet. But as the
weight falls away we can be plagued by a new assault - one we did
not see coming - stretch marks.
Is Retinol Good for Your Skin?
Written by: Craig Elliott |
Distributed: 2007-10-04 |
Word Count: 576 |
Page Views: 19564
| Votes: 48 |
Rating: 2.60
These days, whether you have wrinkles or you are certain that you
will get them in the near future, it is hard to ignore the
hundreds of new anti aging products on the market. With retinol
and AHAs, BHAs and vitamins, it's hard to tell which products
are actually going to work and which ones are will not. While a
lot of the success rate depends on the unique qualities of your
skin, there are scientific studies that have shed light some of
the more popular skin treatments.
Mold Spores In Your Home - How Much Is To Much
Written by: Daryl Watters |
Distributed: 2007-05-15 |
Word Count: 866 |
Page Views: 19438
| Votes: 35 |
Rating: 3.03
Health responses to mold spores can be affected by the length of
time you are exposed to spores, the size or type of spore you are
exposed to, the levels of dust mite and roach allergens,
individual sensitivity to allergens, emotional stress, general
health, as well as other substances and factors that have not yet
been discovered by mold inspectors. Thus, as a result mold spore
levels alone at your property cannot always be relied on to
always answer questions such as "Are molds in my environment
making me sick."
Causes for Yellow or Dark Brown Poop - Symptoms of Healthy Poop - Dr Oz's Tips to Diagnosis Yourself and Self Help
Written by: John Khu |
Distributed: 2009-12-29 |
Word Count: 545 |
Page Views: 16542
| Votes: 18 |
Rating: 1.94
Now the question arises how to detox your body? Body toxins
are accumulated due to improper food consumption; sedentary
lifestyle also causes digestion problem and heavy metal
toxins to accumulate in our body. Therefore, in order to
avoid bowel problem, your body needs to heavy metal detox.
What Does a Stun Gun Do to the Human Body?
Written by: Fred Cheney |
Distributed: 2008-01-02 |
Word Count: 494 |
Page Views: 16415
| Votes: 29 |
Rating: 3.03
The word "stun" has a mysterious ring to it. It is synonymous
with words like "overwhelm," "stupefy," and "daze." What
do these words really mean? In other words, what would happen to
your victim if you touch him with your stun gun? What would
happen to you if you stunned yourself? Could someone be
permanently injured, or worse, die? To sum it up: What are the
effects of a stun gun shock? These are all important questions -
questions with solid answers.
14 Causes of Constipation
Written by: Howard Richman |
Distributed: 2008-12-02 |
Word Count: 1642 |
Page Views: 16276
| Votes: 13 |
Rating: 2.85
For people who know all about drinking liquids and eating fiber
but still have never been able to break free of their curse of
constipation, this article offers many other considerations that
will help the reader find solutions to lifelong constipation.
Highest Ranked "Health And Wellness" Articles
Which Full Face CPAP Mask is Best for You?
Written by: Chris Vasta |
Distributed: 2009-09-01 |
Word Count: 690 |
Page Views: 9670
| Votes: 12 |
Rating: 3.42
If you've been diagnosed with Sleep Apnea, you are
undoubtedly trying to narrow the choice of masks. If your
mouth opens during sleep, one option would be full face CPAP
masks. The full face CPAP mask is used to deliver pressure
through both the nose and mouth. Trying to decide which full
face CPAP mask to use can be complex and expensive. The
number of mask options available is confounding. Based upon
comfort, fit, good seal, and durability, we recommend the
following three full face CPAP masks.
Oyster Extract Improves Men's Sexual Health
Written by: Stephen Kavanagh |
Distributed: 2008-06-26 |
Word Count: 851 |
Page Views: 28655
| Votes: 61 |
Rating: 3.41
Description of the benefits of taking oyster extract powder for
good sexual health in men and women. Details of the features and
benefits, the different brands, the alternatives and advice on
choosing the right oyster extract product.
What Makes Tea So Effective At Preventing Heart Disease?
Written by: Jon M. Stout |
Distributed: 2007-02-02 |
Word Count: 812 |
Page Views: 4582
| Votes: 9 |
Rating: 3.22
Many bodies of research have shown that tea is effective at
preventing heart disease in several ways. Tea prevents the
oxidation of LDL cholesterol into plaque, the hard substance that
clogs our arteries, making us more susceptible to heart attacks
and strokes. Tea is also thought to have an anti-inflammatory
effect, which helps the heart in its overall function.
Green Tea May Positively Effect Stomach Cancer in Habitual Tea Drinkers
Written by: Jon M. Stout |
Distributed: 2006-11-06 |
Word Count: 535 |
Page Views: 4102
| Votes: 11 |
Rating: 3.18
Stomach Cancer is the second-leading cause of cancer-related
deaths in the Western World. In fact, the American Cancer
Society estimates that 22,228 Americans will be diagnosed with
stomach cancer during 2006. They also project that there will be
an estimated 11,430 deaths from this type of disease. Therefore,
the search for a cure for this disease has been a long standing
one. In the past, clinical researchers have hypothesized that
drinking green tea may indeed inhibit stomach carcinogenesis,
and a few case-studies with animals and human beings have
successfully broadened this theory.
A Comparison of Tattoo Removal Methods: Tattoo Removal Skin Peels Vs Tattoo Removal Creams Vs Tattoo Removal Using DermaBrasion
Written by: Abe Granberry |
Distributed: 2009-09-30 |
Word Count: 1821 |
Page Views: 8316
| Votes: 17 |
Rating: 3.18
A friend and I, along with 3 other buddies, decided to try
an experiment to remove tattoos that we have all had for
many years. Over time we just decided we no longer liked
what we saw on our arms, shoulders and chest so we decided
to test all the varieties of tattoo removal except Laser
because none of us could afford the price, plus we wanted to
see for ourselves if the other products actually worked or
were just marketing hype.
Colon Cancer: Risks and Prevention
Written by: Abel Travers |
Distributed: 2007-12-13 |
Word Count: 785 |
Page Views: 3964
| Votes: 6 |
Rating: 3.17
Cancer: it's not a word that anyone really wants to hear. While
not necessarily a death sentence, cancer is an illness that does
have a high mortality rate depending on where in the body it
strikes. Read on as we examine what can be done to head-off Colon
Cancer, the third most common cancer.
Body Detox Tips: The Dos and Don'ts
Written by: John Khu |
Distributed: 2008-12-23 |
Word Count: 496 |
Page Views: 3434
| Votes: 12 |
Rating: 3.17
Most people know about detoxing, but do they know that there are
things that we should and shouldn't do? If not, we will share
some body detox tips today so that they will know whenever they
decide to go on with a detox diet.
Stress is a Killer... Will it get YOU?
Written by: Dr. Rich Starr, PHD Psychology |
Distributed: 2004-10-05 |
Word Count: 1223 |
Page Views: 3004
| Votes: 7 |
Rating: 3.14
I have read a number of times that the medical profession does not know why a preponderance of heart attacks occur on Monday morning throughout the world.
I believe I have found an answer to this riddle.
This Killer Monday Morning Syndrome comes about, I believe, because most people have Saturday and Sunday off from work. Because of this time off from work this gives them more additional time to think about things and therefore add more additional things to their to do list, and presto they wake up Monday morning full of stress and nervousness and don’t realize or know why.
Taking the Shame out of Pudendal Neuralgia!
Written by: Violet Matthews |
Distributed: 2006-10-26 |
Word Count: 1170 |
Page Views: 6829
| Votes: 22 |
Rating: 3.14
Chronic pelvic pain has affected 15-30 percent of women and men
in the world. Finding a diagnosis and treatment can be quite
challenging. Some women and men with chronic pelvic pain have a
very rare disorder called pudendal neuralgia. Learn about the
diagnosis, treatments and outcomes from this extremely painful
neuralgia.
Breast Enlargement Through Natural Herbal Supplements - Is It Safe?
Written by: Asep Komara Sanjaya |
Distributed: 2008-03-11 |
Word Count: 342 |
Page Views: 2620
| Votes: 14 |
Rating: 3.14
Are you interested in larger breasts? Are you trying to take your
look to the next level? If so, you are not alone. There are
thousands of women the world over who are interested in larger
breasts. Not only do they think that this is attractive, but they
also know that men love this as well. But when it comes down to
it, enlarging your breasts is not always the easiest thing to do.
|
|
|
|
|
Article Reprint Rights
|

This work is licensed under a
Creative Commons License
You are not required to show the creative commons license notice when you reprint this work.
|
Article Statistics
|
Word Count: 656
Total Views: 7398
Article Rating: 1.00 of 5
Votes Cast: 5
More Articles By Author:
Articles On This Website
Last Distribution Date:
2008-04-01 11:48:00
Internal ID: #5900
|
|
|