Pharmaceutical Micro

The Great Debate Over B. cepacia Testing

To test, or not to test – that is the question. A frequent reason for recalls of nonsterile products is contamination with Burkholderia cepacia, a microorganism capable of causing serious illness in patients with impaired immune systems or chronic lung…
Read more

Environmental Isolate Case File: Pluralibacter gergoviae

Pluralibacter gergoviae can cause big headaches in cosmetic industry laboratories. It is an opportunistic pathogen that has repeatedly been isolated from personal care products. Recently, 15,000 tubes of a popular skin cream product were recalled due to contamination with the…
Read more

Books for Microbiologists and Anyone Who Loves Science

“It is what you read when you don’t have to that determines what you will be when you can’t help it.”  – Oscar Wilde Microbiologists have an insatiable thirst for knowledge. Keep learning after you leave the lab by reading…
Read more

Get the Facts on Antibiotic Resistance: 18 Helpful Resources

For years, health organizations including the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have warned that antibiotic resistance is a major global threat. The Review on Antimicrobial Resistance  estimates that at least 700,000 people…
Read more

Preservative Testing – Choice of Challenge Isolates

“What you see is that the most outstanding feature of life’s history is a constant domination by bacteria.” ~ Stephen Jay Gould. An effective preservative capability is a central element of drug, cosmetic and household and institutional product microbiological risk assessment…
Read more

Environmental Isolate Case Files: Serratia marcescens

In 1950, a United States Navy ship spent six days spraying Serratia marcescens into the air two miles off the coast of San Francisco. The spraying was part of a biological weapon test called Operation Sea Spray. Prior to the…
Read more

Environmental Isolate Case Files: Ralstonia pickettii

If your manufacturing processes utilize purified water or highly purified water, Ralstonia pickettii should be on your list of microorganisms to control. In fact, it has become a microorganism of concern to sterile drug manufacturers because it is capable of passing through…
Read more

Environmental Isolate Case Files: Bacillus cereus

If you have isolated Bacillus cereus in your pharmaceutical manufacturing environment, you are not alone! Bacillus is one of the most common microorganisms cited in U.S. Food and Drug Administration warning letters associated with contamination in pharmaceutical manufacturing. The top…
Read more

Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products

No pharmaceutical company wants to sell a non-sterile drug contaminated with objectionable microorganisms, but how does a company know which organisms are objectionable and how do they ensure their drugs do not contain them? An objectionable organism is one which…
Read more

Environmental Isolate Case Files: Burkholderia cepacia complex

During 2012, an outbreak of Burkholderia cepacia complex spread throughout the intensive care unit of a German hospital. The illness was traced to contaminated alcohol-free mouthwash. Though this event does not mark the first time B. cepacia complex was recovered from…
Read more