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Let Our Spirit Fly!

Let Our Spirit Fly!

By Daniel Prince, Ph.D.

Our cognitive thinking is very apparent during most of our waking hours. Less apparent and less accessible are the feelings we have. I believe that our feelings are quieted or subdued by our active cognitive processes and the everyday practical work that we do in the real world. I think the willful emphasis on work and earning money dampen or even numb our innate capacity to feel love, joy, and sadness.

It would be great if we can learn to master how to gracefully access the non-cognitive aspects of ourselves like our feelings, our soul and beyond. Think how a memory, or music can suddenly change your mood and how goosebumps come over your body. In these moments we experience a feeling of freedom, happiness and peacefulness. Why do we not experience this aspect of our humanity more of the time? How can we achieve this state on demand? Is it a trait that is being selected for or against from a Darwinian natural selection point of view?

I suggest that we do not experience this part of our reality because the environment that we live in is not perceived as a safe place by our reptilian brain at our brainstem. We may not experience that our safety is in imminent life threatening danger and nor do we experience that we are totally without worry or repressed fears. In our routine normal existence we are numb to the possibility of a (higher) different experience of ourselves. Perhaps mostly we never make the effort to exercise the more evolutionarily recent cognitive brain.

Meditation is a practice to train the mind to be one with the body. In it you focus the mind on breathing and work on making your body flexible and nimble. That, however, is not what I am describing. I am describing a feeling that is like a force coming over you that makes your body tingle with power that normally you do not feel. A feeling that you are little afraid of to let it take over you. It is a feeling that to be one with, that is to fully experience, you must surrender to it. Is it God’s presence?

I think, however, we have the ability to access this power by just mentally granting permission to whatever this force is to be with us. I think this is how we can access and experience the universe independent of our biological senses of sight, sound, taste, touch and smell. This experience may be a form of energy which I suggest is the home of where all things arise from, return to and our renewed in the cycle of life.

In our understanding of our physical world we know that all things arise from a singularity. Over time the singularity grew by addition and the physical world was made. The opposite of addition is subtraction and we know death and the transient nature of all things. From the singularity first there was energy and invisible gasses. Later liquids and solids were formed and last plants and animals arose from this singularity.

The goosebumps you feel are perhaps our body’s nascent capacity to sense more than our normal biologically based reality. It is possible that the biological tissue that makes up our brain is evolving to heighten its capacity for extra sensory perception. In the future we may not depend upon or need our body’s five senses and limbs to know the universe. The force of creation is always around us and perhaps our “antenna” (i.e., brain) is a growing biological receptor for connection with the invisible energy and force of the universe and all that it brings with it!

Daniel Prince,Ph.D.
973 227 6882 x. 519
danielprince@gibraltarlabsinc.com
www.gibraltarlabsinc.com

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The search for science based leadership

The Search for Science Based Leadership

 

Science is the study of a subject.  Science is very helpful for the understanding of the physical world. Science allows for predictions of future events. Physics, mathematics, chemistry and biology all help us understand what is happening in our environment. For example, from physics we know gravity, from mathematics we know geometry and calculus, from chemistry we know chemical reactions and from biology we know about how life is formed.

As people, like other animals and plants, the outer appearance of ourselves, i.e., our body lives in the physical world. However, our emotions, soul, thinking, consciousness, behaviors are not outwardly present in the physical world. These vital attributes are the subject of great interest and study in various social sciences. Physics, for example, cannot help us explain what values we hold nor why we hold them.

I think that there is an infinite variety of individual human expression that is influenced by our senses, emotions and cognitive reasoning of stimuli. Commonalities and patterns of human behavior do exist which, however, often dramatically change over time. For example, views on religion, homosexuality, marriage, and leadership.

Position power was the dominant style of leadership for many years. Now that style of leadership does not work in most companies. Instead, great leaders are thought to be effective because they can influence those around them and possess gravitas and veritas.

Running a business successfully is the goal of most business leaders.  Many business people reach for scientific constructs to systemize their processes and structures to obtain reliable outcomes.  They should not however, expect to achieve the desired outcome with any level of confidence as is the case of the sciences. This is because the “scientific” foundation being used in business is not sufficient. The probability of attainment of the desired outcome cannot be calculated involving people.

The overall success of people and organizations, in the end, is more a function of individual and collective capabilities, a willingness to learn, practice, passion and good habits. Running a great company that is successful and sustainable in a global marketplace is competitive and challenging.

Best,

Daniel Prince,Ph.D.

973 227 6882 x. 519

danielprince@gibraltarlabsinc.com

www.gibraltarlabsinc.com

 

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Challenges to Validation of a Complex Non-Sterile Medical Device Tray

BITThis scientific publication is an important case study. The challenges associated with demonstrating to a very high level of assurance of sterility are discussed in the context of case design, instruments, density, F0, maximum load configuration, minimum load configuration. In addition, the biological testing using qualitative and quantitative methodologies are illustrated.

The web address is, http://www.aami.org/publications/BIT/index.html

and in print

Challenges to Validation Of a Complex Nonsterile Medical Device Tray
Daniel Prince, Jozef Mastej, Isabel Hoverman, Raja Chatterjee, Diana Easton, and Daniela Behzad
Biomedical Instrumentation & Technology, Vol. 48, No. 4, July/August 2014: 306-311.
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“Microbiological Testing and Contamination Control – an opinion on the microbial limit test with reference to harmonization”

contractpharmaDear All,

Gibraltar Laboratories has published its 90th paper. The current issue of Contract Pharma has our article entitled “Microbiological Testing and Contamination Control – an opinion on the microbial limit test with reference to harmonization”. We are proud of the contributions of our technical services team to this effort: Christopher Waskewich, Kristah Kohan and Danina Rinaldi.  Our paper provides an opinion on the harmonization of USP microbial limits testing. It provocatively analyzes the changes that were made to USP Chapter <62> in order to win consent from the Europeans. You will find a copy  at https://www.gibraltarlabsinc.com/publications.html.

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GIBRALTAR IS THE NJ 2013 FAMILY BUSINESS OF THE YEAR: GOVERNOR CHRIS CHRISTIE

Dear Friends

Governor ChristieProcalamation

Gibraltar was AGAIN awarded with another prestigious award – the 2013 New Jersey Family Business of the Year Award!

This award is presented by the Rothman Institute of Entrepreneurial Studies at Fairleigh Dickinson University’s Silberman College of Business. The award was presented to Gibraltar Laboratories by New Jersey’s Governor Chris Christie at a ceremony on October 16, 2013.

Thank you for all of your continued support of Gibraltar Laboratories!

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Burkholderia cepacia and BCC – the next indicator organism?

BccHistory

The main interest in the presence of pseudomonads of any type (including Burkholderia cepacia complex (BCC) – the former Pseudomonas cepacia) is that they are strictly water-borne organisms (deionized water) which is used as the main ingredient in all of the medicaments listed in this report. Gram negative bacilli of this type thrive heartily in deionized water because of the sparse nutritional requirements.  Pseudomonas cepacia was first discovered by Walter Burkholder in 1949 while studying the cause of onion rot and gained more recognition in the 1980’s after it was found to cause a 35% death rate in cystic fibrosis patients that became infected, and subsequently was renamed in his honor.

Burkholderia cepacia is from a group of catalase-positive, lactose-negative, gram negative aerobic bacteria. Gram negative bacilli are divided into three biochemical groups based on their metabolism of glucose fermenters, non-fermenters, oxidizers.  E. coli, acaligenes and Pseudomonas/cepacia are examples of these three groups, respectively. They are motile due to a polar flagellum. Sometimes referred to as the Burkholderia cepacia complex (BCC) the group is comprised of B. ambifaria, B. anthina, B. cenocepacia, B. cepacia, B. dolosa, B. multivorans, B. pyrrocinia, B. stabilis, B. vietnamiensis and several others. BCC organisms are typically isolated from water, soil and agricultural products.

BCC organisms are naturally multi-drug resistant to many common antibiotics such as polymyxin B and aminoglycosides. There is a special agar called “Oxidation-fermentation polymyxin-bacitracin-lactose (OFPBL) that contains polymyxin (which inhibits most gram negative bacteria, including Pseudomonas aeruginosa) and bacitracin (which inhibits most gram positive bacteria as well as Neisseria sp.).  The presence of lactose distinguishes between fermenting and non-fermenting gram negative bacilli by rendering the medium yellow in the presence of lactic acid and bromthymol blue.

The microbe is able to remain viable for many months in harsh conditions such as low and high temperature extremes (12C to 48C) and in the presence of organic solvents, low nutrients, antiseptics, preservatives, antibiotics and preservatives. It has been found to survive for months in water (low nutrient) but for only maybe 1 week on a dry surface. Its ability to survive such conditions is due to its ability to produce a biofilm.

Over the years B. cepacia has become notorious for its ability to grow in the presence of the substances it is supposed to inhibit e.g., benzalkonium chloride in the barber shop and povidone-idoine antiseptics. A famous paradoxical case of antiseptic drug resistance occurred several years ago with the incident of pseudobacteremia where blood cultures grew cepacia but the organism did not come from blood – it came from contaminated PVP-I that was used to decontaminate the blood culture bottle.

Gibraltar recommends adding this organism to preservative challenge testing, disinfectant validations for facilities and USP <61/62> as our experience has indicated that it can be more resistant to standard preservatives than organisms in the current battery of USP methods. It can be noted though that finished product testing can yield false-negative results due to “nutrient shock” when using nutrient rich media. Special cultivation is necessary (pre-enrichment step) confirmatory identification.

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USP Statistical Analysis

 

Non-sterile (P)
Rate

Non-sterile (P)
Rate

Units
Tested (N)

Percent chance to fail sterility test (F)

1:10,000

0.0001

1

0.01

1:1000

0.001

1

0.1

1:100

0.01

1

1.0

1:10

0.1

1

11.1

1:10,000

0.0001

5

0.05

1:1000

0.001

5

0.5

1:100

0.01

5

5.3

1:10

0.1

5

82.4

1:10,000

0.0001

10

0.10

1:1000

0.001

10

1.0

1:100

0.01

10

11.1

1:10

0.1

10

271.8

The above probability of a false negative sterility test F is calculated without respect to the sample volume tested. It is based on the number of units tested and the contamination rate P. Obviously, if a preparation has a contamination rate of P and N units are tested for sterility then the percent chance of correctly identifying a true sterility failure F is directly proportional to the volume of medium tested.

In this example I have highlighted the case where 1 in 1000 units are expected to be non-sterile. Ideally, a sterility test will correctly identify this level of contamination. However, the USP <71> test does not accomplish this. The chance of correctly identifying this level of contamination is 1, 0.5 and 0.1% when 10, 5 or 1 units are tested. Thus, even when 10 units are tested the USP sterility test will miss the contamination event 99% of the time.

Non-sterile (P)
Rate

Non-sterile (P)
Rate

Units
Tested (N)

Percent chance to fail sterility test (F)

1:1000

0.001

1

0.1

1:1000

0.001

2

0.2

1:1000

0.001

3

0.3

1:1000

0.001

4

0.4

1:1000

0.001

5

0.5

1:1000

0.001

6

0.6

1:1000

0.001

7

0.7

1:1000

0.001

8

0.8

1:1000

0.001

9

0.9

1:1000

0.001

10

1.0

1:1000

0.001

20

2.0

1:1000

0.001

40

4.2

In this table it is shown that the chances of correctly identifying a contaminated lot when the contamination rate is 1 in 1000 as a function of sample size. When only a single unit is tested then the there is a 0.1% chance of an accurate result or a 99.9% chance of a False negative result. By expanding the test to include 40 units as the sample size the chance of correctly identifying the non-sterile lot slightly increases to about 4.2%.

Accordingly, any rational to justify a reduced number of units tested should take into account the limits of the statistical meaning of the USP sterility test.

Respectfully Submitted,

By: Daniel Prince

 

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USP Sterility test: The probability of a false negative result is high

Non-sterile (P)
Rate

Non-sterile (P)
Rate

Units
Tested (N)

Percent chance to fail sterility test (F)

Percent False NegativeResult

1:10,000

0.0001

1

0.0

99.99

1:1000

0.001

1

0.1

99.90

1:100

0.01

1

1.0

99.01

1:10

0.1

1

9.5

90.48

1:10,000

0.0001

5

0.0

99.95

1:1000

0.001

5

0.5

99.50

1:100

0.01

5

4.9

95.12

1:10

0.1

5

39.3

60.66

1:10,000

0.0001

20

0.2

99.80

1:1000

0.001

20

2.0

98.02

1:100

0.01

20

18.1

81.87

1:10

0.1

20

86.5

13.54

The above probability of a false negative sterility test F is calculated without respect to the sample volume tested. It is based on the number of units tested and the contamination rate P. Obviously, if a preparation has a contamination rate of P and N units are tested for sterility then the percent chance of correctly identifying a true sterility failure F is directly proportional to the volume of medium tested.

In this example refer to the case where 1 in 1000 units are expected to be non-sterile. Ideally, a sterility test will correctly identify this level of contamination. However, the USP <71> test does not accomplish this. The chance of correctly identifying this level of contamination is 2, 0.5 and 0.1% when 20, 5 or 1 units are tested. Thus, even when 20 units are tested the USP sterility test will miss the contamination event 98% of the time

Non-sterile (P)
Rate

Non-sterile (P)
Rate

Units
Tested (N)

Percent chance to fail sterility test (F)

Percent False NegativeResult

1:1000

0.001

1

0.1

99.9

1:1000

0.001

2

0.2

99.8

1:1000

0.001

3

0.3

99.7

1:1000

0.001

4

0.4

99.6

1:1000

0.001

5

0.5

99.5

1:1000

0.001

6

0.6

99.4

1:1000

0.001

7

0.7

99.3

1:1000

0.001

8

0.8

99.2

1:1000

0.001

9

0.9

99.1

1:1000

0.001

10

1.0

99.0

1:1000

0.001

20

2.0

98.0

1:1000

0.001

40

3.9

96.1

In this table it is shown that the chances of correctly identifying a contaminated lot when the contamination rate is 1 in 1000 as a function of sample size. When only a single unit is tested then there is a 0.1% chance of an accurate result or a 99.9% chance of a False negative result. By expanding the test to include 40 units as the sample size the chance of correctly identifying the non-sterile lot slightly increases to about 3.9%.

Accordingly, any rational to justify a reduced number of units tested should take into account the limits of the statistical meaning of the USP sterility test.

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Women and Their Beauty: How people see you as more beautiful than you see yourself

womanI know that we are often very critical of how we look and how we sound to others. In general we want to “look good” in the eyes of others. Perhaps our reality of ourselves is vastly different than the the reality of others that know us. This video explores the attitudes of women and compares their description of themselves to that of others as illustrated by a forensic artist. Women are more beautiful in the eyes of others than they are to themselves. Watch this interesting thought exercise.
http://www.facebook.com/photo.php?v=120357218161699Women and Their Beauty: How people see you as more beautiful than you see yourself

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Helping Compounding Pharmacies

I have just returned from an all-day consultation audit of a compounding pharmacy. Our role is to perform a critical audit to help the firm identify the source of a fungal contaminate that was found in its sterile preparations. It is necessary to find the root cause and then the firm must institute both preventive and corrective actions.

We know that current good manufacturing practice regulations and FDA oversight are relatively new to the compounding pharmacy industry. We also all see firsthand how FDA and state Boards of Pharmacy are working closely together because of the tragedies that arose from the poor practices recently in Massachusetts [NECC].

The point of this blog is to let you know that we care about the survival of your industry. We want to work with pharmacies which have integrity about offering only safe scripts for their customers/patients. We can provide over 43 years of knowledge to help you adjust and forward your path to the new current expectations as relates to microbiological monitoring, facility design and training.