Friday, 29 April 2016

Air-sampled Filter Analysis for Endotoxins and DNA Content



Two complementary analyses of atmospheric biological particles from air sampled filters are described herein: the extraction and detection of endotoxin, and of DNA.

This makes for an interesting presentation, which is hosted by the website Jove.

Outdoor aerosol research commonly uses particulate matter sampled on filters. This procedure enables various characterizations of the collected particles to be performed in parallel. The purpose of the method presented here is to obtain a highly accurate and reliable analysis of the endotoxin and DNA content of bio-aerosols extracted from filters. The extraction of high molecular weight organic molecules, such as lipopolysaccharides, from sampled filters involves shaking the sample in a pyrogen-free water-based medium. The subsequent analysis is based on an enzymatic reaction that can be detected using a turbidimetric measurement. As a result of the high organic content on the sampled filters, the extraction of DNA from the samples is performed using a commercial DNA extraction kit that was originally designed for soils and modified to improve the DNA yield. The detection and quantification of specific microbial species using quantitativepolymerase chain reaction (q-PCR) analysis are described and compared with other available methods.
The presentation can be viewed here.

Posted by Dr. Tim Sandle

Thursday, 28 April 2016

Antibiotic resistance training slides


The U.S.  is doing a better job of preventing healthcare-associated infections (HAIs), but more work is needed – especially in fighting antibiotic-resistant bacteria. The Centers for Disease Control and Prevention (CDC)'s latest Vital Signs report urges healthcare workers to use a combination of infection control recommendations to better protect patients from these infections.

For further details see: Infection Control Today

Posted by Dr. Tim Sandle

Wednesday, 27 April 2016

Pharmig News #63


The latest edition of Pharmig News has been issued (the newsletter of the Pharmaceutical Microbiology Interest Group). In this issue there is:
  • An update on Pharmig activities by David Keen, Chairman of Pharmig.
  • A review of Pharmig training sessions on environmental monitoring and sporicides by Andrew Ramage.
  • A profile of Pharmig Committee member Laura Guardi.
  • A review of the changes to ISO 14644 Parts 1 and 2, by Tim Sandle.
  • Plus the latest regulatory and microbiology news.

Copies have been sent to member organisations. If you would like to see a copy, please email the Pharmig office.



Posted by Dr. Tim Sandle

Pharmig Conference – March 2016



Keeping up to date with topical information and views on microbiologically related topics
The Oxfordshire Golf Club, Hotel and Spa was the venue for two Pharmig conferences on the 2nd and 3rd of March.  The 2nd March conference was the Best Practices in Environmental Monitoring: Covering Steriles and Non-Steriles.  The 3rd March conference was the Latest Updates on Sporicides – As Part of Your Transfer Process aimed mainly at NHS staff.

Andrew Ramage of Chewell Laboratories has written a good report on the event, which can be found here.



 Posted by Dr. Tim Sandle

Tuesday, 26 April 2016

A closer look at Zeta Potential and Particle Sizing


Free eBook from Micromeritics brings valuable insight and the latest zeta potential and particle sizing technologies.

What's in this eBook:

1.         The principle of Zeta Potential measurement
2.         The Principle of Particle Sizing
3.         Interview with Jack Saad - Nano Particle Sizing and Zeta Potential
4.         The latest NanoPlus HD products
5.         Zeta Potential and Particle Sizing Spec sheets

For details see: Micromeritics



 Posted by Dr. Tim Sandle

Monday, 25 April 2016

The Sage Encyclopedia of Pharmacology and Society

The SAGE Encyclopedia of Pharmacology and Society explores the social and policy sides of the pharmaceutical industry and its pervasive influence in society. While many technical STM works explore the chemistry and biology of pharmacology and an equally large number of clinically oriented works focus on use of illegal drugs, substance abuse, and treatment, there is virtually nothing on the immensely huge business (“Big Pharma”) of creating, selling, consuming, and regulating legal drugs.

With this new Encyclopedia, the topic of socioeconomic, business and consumer, and legal and ethical issues of the pharmaceutical industry in contemporary society around the world are addressed.

I have contributed several entries across the four volumes. These are:

Sandle, T. (2016) Antibiotic / Antimicrobial Resistance. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 1, Sage Publications: Los Angeles, pp136-139

Sandle, T. (2016) Antimalarials. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 1, Sage Publications: Los Angeles, pp190-192

Sandle, T. (2016) Drug-Resistant Diseases. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles, pp546-550

Sandle, T. (2016) European Medicines Agency. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles, pp593-596

Sandle, T. (2016) Lyme Disease. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles, pp842-844

Sandle, T. (2016) Medicines and Healthcare Products Regulatory Agency (UK). In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles, pp899-902

Sandle, T. (2016) National Institute For Biological Standards and Control. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 3, Sage Publications: Los Angeles, pp948-950

Sandle, T. (2016) Smallpox Eradication. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 3, Sage Publications: Los Angeles, pp1298-1301

Sandle, T. (2016) U.S. Pharmacopeial Convention. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 4, Sage Publications: Los Angeles, pp1503-1505

For details, see Sage.

Posted by Dr. Tim Sandle

Sunday, 24 April 2016

Top 5 Most Read Bioprocessing Articles of 2015


Bioprocessing International has put together a free publication of the most read articles relating to pharmaceutical processing published in the magazine during the course of 2015.

To access the articles, see: Bioprocessing International



 Posted by Dr. Tim Sandle

Saturday, 23 April 2016

Medical Marijuana Glossary


Aeroponics: Where plants roots are suspended in air so that nutrients and water can be sprayed into the root zone in the form of fine mist.

Analgesic: A type of drug used to achieve analgesia (relief from pain).

Anandamide: This is a neurotransmitter that plays a role in pain sensation, memory, and sleep. THC is believed to interact with parts of the brain normally controlled by anandamide.

Autoflower cannabis: A type of Cannabis that will enter the flowering stage at any time despite any growing conditions.

Axil: The joint between the leaf or leaf stalk and the stem that carries it.

Bhang: A preparation from the leaves and flowers (buds) of the female cannabis plant, smoked or consumed as a beverage.

Bong: A smoking device used to filter marijuana smoke. Water is generally added to help with the filtration process.

Brownies: Preparations made from marijuana and rolled into little balls, then smoked

Bud: Refers to the buds or flowers of the marijuana plant, sold for recreational drug use. In botany, the term refers to the undeveloped shoot of a plant, normally occurring in the axil of a leaf or at the tip of the stem.

Butter:  A butter-based solution which has been infused with cannabinoids. Sometimes called "Magical Butter", "Cannabutter", "butterjuana", or "marijuana butter".

Cannabis (plant): Cannabis is an annual flowering herb, indigenous to Central Asia, and South Asia but capable of being grown worldwide. The genus Cannabis contains two species which produce usable amounts of psychoactive cannabinoids. Cannabis indica produces a higher level of Cannabidiol relative to THC (the primary psychoactive component in medical and recreational cannabis). Cannabis sativa, on the other hand, produces a higher level of THC relative to cannabinoids.

Cannabis (drug): An alternative name for marijuana.

Cannabis Club: A group of people who join together to supply medical marijuana to patients.

Cannabis subculture: A counterculture terms for groups of people united by a common understanding of the meaning and value of the use of marijuana.

Cannabidiol: After THC, the second most abundant constituent of the Cannabis plant. Cannabidiol is less psychoactive than THC. However, it is considered to have a wider scope of medical applications, including to epilepsy, multiple sclerosis spasms, anxiety disorders, Bipolar Disorder, schizophrenia, nausea, convulsion and inflammation, as well as inhibiting cancer cell growth.

Cannibinoids: Cannabinoids are a group of terpenophenolic compounds present in Cannabis and occur naturally in the nervous and immune systems of animals. The Cannabis plant contains over eight different cannibionoids. These are sometimes referred to as phytocannabinoids to contrast them with the cannibinoids that naturally occur in the brain (endocannabinoids).

Cannabinoid receptors: Specific membrane-bound receptors in the bodies of animals, including people. They are affected by cannibinoids. There are two types of receptor: CB1 receptors, which are found primarily in the brain; and CB2 receptors, which are found in the immune system.

Cannabinoid receptor 1 (CB1): One of the two known receptors in the endocannabinoid (EC) system associated with the intake of food and tobacco dependency. Blocking the cannabinoid receptor 1 may reduce dependence on tobacco and the craving for food.

Cannabinoid receptor 2 (CB2): One of the two known receptors in the endocannabinoid (EC) system. It is related to immune activity.

Central Nervous System: Part of the body that contains the majority of the nervous system and consists of the brain and the spinal cord. It has a fundamental role in the control of behavior.

Chromatographic techniques: Describes a set of laboratory techniques for the separation of mixtures.

Clinical trials: Sets of tests in medical research and drug development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments). They are normally controlled by national regulators.

Delta-9-tetrahydrocannabinol: See THC.

Depressant: A drug compound that lowers or depresses arousal levels and reduces excitability.

Dispensary: A service that dispenses medications and medical supplies. In a traditional dispensary set-up a pharmacist dispenses medication as per prescription or order form. in parts of the U.S., medical marijuana is sold in specially designated stores called dispensaries or "compassion clubs".

Drug testing: THCs can be measured in blood, urine, hair, oral fluid or sweat using chromatographic techniques. The Duquenois-Levine test is commonly used as a screening test.

Duquenois–Levine Test: An established screening test for the presence of marijuana. Marijuana (as well as a variety of other plant substances) becomes purple with the addition of the Duquenois reagent and hydrochloric acid. Upon addition of the organic solvent, the purple color transfers to the organic layer, indicating that cannabinoids may be present.

Edibles: Food products made with cannabis in herbal or resin form, including hash brownies and space cakes.

Efficacy: A drug is considered to have efficacy if it produces the desired effect. It can also be used as a relative term, to indicate that one drug is more efficacious than another.

Endocannabinoid system: A term given to a group of lipids and receptors that are involved in a variety of physiological processes. The ECS an important component in many different homeostatic processes in living organisms, including food intake, energy metabolism and reward processing. Certain cannabinoids, including THCs, can affect the ECS.

Euphoria: A medically recognized as a mental and emotional condition in which a person experiences intense feelings of well-being, elation, happiness, excitement, and joy.

4:20 (four-twenty): A code-term that refers to the consumption of cannabis and by extension, as a way to identify oneself with cannabis subculture or simply cannabis itself.

Gateway theory: The theory that the use of less deleterious (noxious) drugs may lead to a future risk of using more dangerous hard drugs. It is attributed by some that the use of marijuana might lead to the user trying for dangerous drugs.

Hallucinogen: Psychoactive drugs that can cause subjective changes in perception, thought, emotion and consciousness.

Hashish: A cannabis product composed of compressed or purified preparations. It can be in a solid form or as a paste. The prpearation of hashish means that it has very high levels of THC and other cannabinoids. Hashish is consumed by consumed by being heated in a pipe or a vaporizer.  The term is sometimes abbreviated to 'hash'.

Hash oil: This is a resinous matrix of cannabinoids obtained from the cannabis plant by solvent extraction. This process makes the oil very potent in THCs (with some forms having a concentration of 60% THCs). The oil is consumed using a vaporizer or it can be rubbed onto the skin.

Hemp: A term for varieties of the Cannabis plant and its products, which include fiber, oil, and seed. Hemp is refined into products like hemp seed foods, hemp oil, wax, resin, rope, cloth, pulp, paper, and fuel.

Hemp wick: A hemp rope dipped in beeswax. It can be used for smoking marijuana.

Hybrids: Cannabis plants that are a cross between Sativa and Indica.

Hydroponics (Hydro): A method of growing plants, like Cannabis, using mineral nutrient solutions, in water, without soil. Plants can be grown with their roots in the mineral nutrient solution only or in a medium like perlite, gravel, mineral wool, expanded clay pebbles or coconut husk.

Indica: An abbreviation for the plant Cannabis indica. Indica is used to refer to marijuana sourced from the plant. Cannabis indica tends to have a higher cannabidiol content than Cannabis sativa strains (or sativa marijuana).

Infusions: Where marijuana is mixed with the solvent and then pressed and filtered to express the oils of the plant into a solvent. The solvent can be used in cannabis foods or applied to the skin.

Intravenous: Intravenous (IV) medications are a solutions administered directly into the venous circulation via a syringe

Kief: A powder, rich in trichomes (Sticky resinous growths on the Cannabis plant), which can be shifted from the leaves and flowers of cannabis plants and either consumed in powder form or compressed to produce cakes of hashish.

Marijuana: A dry, shredded mix of flowers, stems, seeds and leaves of the Cannabis plant. Marijuana produces psychoactive and physiological effects when consumed. The immediate effects from consuming cannabis include relaxation and mild euphoria. The term is synonymous with 'cannabis'.

Marihuana: An alternate spelling of “marijuana,” most common in the early 1900s. “Marihuana” appears in Canada’s Controlled Drugs and Substances Act. As a result, Health Canada uses “marihuana” in legal documents related to the Act, such as Marihuana Medical Access Regulations.

Marihuana Medical Access Regulations (MMAR): Canadian government regulations that allow approved and licensed patients to possess and use marijuana to treat specific medical illnesses or conditions. To read the Marihuana Medical Access Regulations online, visit: http://laws.justice.gc.ca/PDF/Regulation/S/SOR-2001-227.pdf.

Medical  marijuana: The parts of the herb Cannabis used as a form of medicine or herbal therapy.

Medical necessity: In the United States medical necessity refers to legal doctrine, related to activities which may be justified as reasonable, necessary, and appropriate, based on evidence-based clinical standards of care. In some other countries the term clinical medical necessity is used.

Nausea: Stomach queasiness, the urge to vomit. Nausea can be brought on by many causes, including medications or pain.

Neuron: An electrically excitable cell that processes and transmits information through electrical and chemical signals.

Neuroprotection: Refers to mechanisms and strategies used to protect against neuronal injury or degeneration in the Central Nervous System (CNS) following acute disorders (such as stroke or nervous system injury/trauma) or as a result of chronic neurodegenerative diseases (for example, Parkinson's, Alzheimer's, Multiple Sclerosis).

Neurotransmitter: Chemicals in the body that transmit signals from a neuron to a target cell. There are a range of different types in the body, for example one neurotransmitter (acetylcholine) has a role in connecting motor nerves to muscles; whereas dopamine controls pleasures related to motivation and also emotional arousal; and serotonin regulates appetite, sleep, memory and learning, temperature, mood, behaviour, muscle contraction, and function of the cardiovascular system and endocrine system.

Oils: Cannaoils or marijuana oils are cooking oil based products that have been infused with cannabinoids. This is accomplished by performing an extraction of certain chemical constituents of cannabis into the oil through various methods.

One-eighth/half-quarter: Usually refers to an eight on an ounce. Used commonly when talking about drugs, especially marijuana. Equals our to around 3.5 grams.

Percolator: A small sub-chamber inside of a water pipe (or bong) that provides a smoke-water interaction via dissolution. It allows more filtering of the smoke through water.

Pharmacology: The branch of medicine and biology concerned with the study of drug action.

Phytocannabinoids: Phytocannabinoids are only known to occur naturally in significant quantity in the cannabis plant. They are alternatively known as also called 'natural cannabinoids, herbal cannabinoids, or classical cannabinoids.

Placebo-controlled: A term used to describe a method of research in which an inactive substance (a placebo) is given to one group of participants, while the treatment (usually a drug) being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective than the placebo.

Pot: A slang word for marijuana. Other 'street terms' include: bud, cheeba, chronic, dagga, dak, dank, dope, doobage, draw, dro, electric puha, frodis, ganja, grass, green, hash, hay, herb, indo, instaga, kind bud, killer bud, kind, leaf, Mary Jane, nugget, nug, pot, reefer, schwag (low quality), sensi, skunk, sticky-icky-icky, tea, tree, wacky tobacky, weed.

Potency: A measure of the activity of a drug in a biological system, expressed in terms of the amount required to produce an effect of given intensity.

Psychoactive: Psychoactive substances often bring about subjective changes in consciousness and mood that the user may find pleasant (e.g. euphoria) or advantageous (e.g. increased alertness).

Psychoactive drug: A chemical substance that crosses the blood–brain barrier and acts primarily upon the central nervous system where it affects brain function, resulting in alterations in perception, mood, consciousness, cognition, and behavior. Psychoactive drugs are prescribed for the management of mental and emotional disorders, such as depression.

Psychotomimetic: A drug with actions that mimics the symptoms of psychosis, including delusions and/or delirium, as opposed to just hallucinations. Some cannabinoids are psychotomimetic.

Purity: Refers to how much of the required active ingredient is present in a drug relative to unwanted material or additives. With marijuana, purity normally refers to the proportion of THC present.

Resin: A hydrocarbon secretion of many plants, including Cannabis. It is found on the trichromes of the plant and is used for making marijuana. Sometimes referred to a 'plant tars'.

Sativa: An abbreviation for the plant Cannabis sativa. Sativa is used to refer to marijuana sourced from the plant. The plant produces higher levels of THCs than the other main cannabis plant, Cannabis indica.

Shake: A term for marijuana crumbs or 'weed crumbs'. These are the small bits of marijuana bud that settle to the bottom of a bag. Sometimes called ' shwag'.

Smoking: In relation to marijuana, smoking involves inhaling vaporized cannabinoids ("smoke") from small pipes or a vaporizer.

Spasticity: An unusual tightness, stiffness, or pull of muscles. In extreme cases a lack of inhibition results in excessive contraction of the muscles, ultimately leading to hyperflexia (overly flexed joints).

Stimulant: Psychoactive drugs which induce temporary improvements in either mental or physical functions or both.

Sublingual: A term for using strips or drops of marijuana under the tongue.

Synthetic cannabinoids: Chemicals that are analogous to cannabinoids, such as those found in the Cannabis plant. They are based on the structure of herbal cannabinoids.

Tea: Cannabis tea is made by first adding a saturated fat to hot water (e.g. cream or any milk except skim) with a small amount of cannabis. Cannabis tea contains relatively small concentrations of THC because THC is an oil and it is only slightly water-soluble.

Tetrahydrocannabinol (THC): The principal psychoactive constituent of cannabis. As well as being psychoactive, THC has mild to moderate analgesic effects and can be used for the treatment of pain. Other effects include relaxation, alteration of visual, auditory, and olfactory senses, fatigue, and appetite stimulation.

Tincture: Cannabinoids can be extracted from cannabis plant matter using high-proof spirits (often grain alcohol) to create a tincture. To be classified as a tincture, the extract should have an ethanol percentage of at least 40–60% or 80–120 proof.

Titration: A laboratory method of quantitative chemical analysis that is used to determine the unknown concentration of an identified substance.

Toke: A phrase meaning to inhale marijuana smoke.

Toxicology: The study of the adverse effects of chemicals on living organisms, including the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people.

Toxicity: Toxicity is the degree to which a substance can cause damage or harm. Toxicity can be physical, chemical or biological. 

Trichomes: THC-producing resin glands of the cannabis plant (specifically the sticky coating). Hairs or trichomes may be formed on all parts of a plant as outgrowths from an epidermal cell.

Vaporizer: A device used to extract for inhalation the active ingredients of Cannabis. Vaporization is an alternative to burning (smoking) that avoids the inhalation of many irritating toxic and carcinogenic by-products.



Posted by Dr. Tim Sandle

Friday, 22 April 2016

Sugar in leafy greens may help gut bacteria


The sugar is called sulfoquinovose (SQ) and is made in green leaves by photosynthesis - the process by which plants use energy from the sun to make chemical energy in the form of sugars. Bacteria use SQ as a source of carbon and sulfur.

Sulfur is important for building proteins - the essential building blocks of all living organisms - explain the authors, who point out that SQ is the only sugar molecule that contains sulfur.

The team thinks it may be possible to use enzymes like YihQ to deliver highly specific antibiotics that target harmful forms of E. coli and other bacteria, such as the food-poisoning bacteria Salmonella, while leaving the good bacteria alone.

When bacteria break down SQ from plants, they release sulfur into the environment, where it re-enters the global sulfur cycle and is used again by the other organisms.

For further details, see: medical news

Posted by Dr. Tim Sandle

FDA - Data Integrity and Compliance With CGMP


The U.S. Food and Drug Administration (FDA) has released an important draft guidance for industry. the title is: "Data Integrity and Compliance With CGMP Guidance for Industry."

Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves information. Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.

The introduction to the FDA guidance reads:

"The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements.

FDA expects that data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models."

The draft guidance can be accessed here.




Posted by Dr. Tim Sandle

Thursday, 21 April 2016

Bacteria Communicate Like Brain Cells



Recent work, published in Nature, demonstrates that bacterial cells communicate with each other using ions and ion channels, much like brain cells. In fact, the proteins that form bacterial ion channels are homologous to those in plants and animals. This provides compelling evidence for how individual bacterial cells work in concert to form biofilms. This also provides a new mechanism for antibiotics: dispersing bacteria instead of killing them. This would lead to less bacterial resistance and prevent the destruction of healthy commensal species.

See here for further details.



Posted by Dr. Tim Sandle

Pharmakon's Nationwide Recall

Pharmakon Pharmaceuticals, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals, Inc. that remain within expiry due to the FDA’s concern over a lack of sterility assurance and other quality issues.

Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. To date, Pharmakon Pharmaceuticals, Inc. has not received any reports of adverse effects or injuries.

These compounded sterile products are used for a variety of indications and are packaged in bags, syringes, and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address, and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.

Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products.



Posted by Dr. Tim Sandle

Wednesday, 20 April 2016

ISO 18385:2016, Minimizing the risk of human DNA contamination in products


A new ISO standard of interest has been published - ISO 18385:2016 "Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes -- Requirements."

The standard is concerned with:

ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis.

The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables.

ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design).

ISO 18385:2016 excludes microbiological testing.

ISO 18385:2016 specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.

For details, see ISO.



Posted by Dr. Tim Sandle

Tuesday, 19 April 2016

What is the impact of disinfectants on environmental testing?


The environmental testing program is one of the essential elements for controlling the quality of the pharmaceutical production environment. It is therefore essential to employ monitoring solutions capable of detecting any deviation which might lead to loss of this control. In practical terms, environmental control relies mainly on the use of agar culture media which must permit the recovery of all potential living microorganisms but also neutralization of any disinfectant residues which can inhibit the growth of some strains, while supporting a level of growth that can be seen by an operator.

The quality of test results depends on the performance of these media as very clearly does the pertinence of the resultant trend analyses. But validating culture media that are able to recover stressed bacteria from the environment in a cleanroom is not so simple! To gain a better understanding of the interaction between culture media and the disinfectants dedicated to environmental control, we have studied the properties of the biocides most commonly used in the pharmaceutical industry and have suggested a methodology to evaluate their impact on the performance of these media.


In relation to the above, Laurent LEBLANC has written an interesting article for the magazine La Vague. The article can be found here.

Posted by Dr. Tim Sandle

Monday, 18 April 2016

New chair of the European Pharmacopoeia Commission elected


During its 154th session, which took place on March 15-16, the European Pharmacopoeia (Ph. Eur.) Commission elected Dr Tobias Gosdschan as its Chair for a term from June 2016 to June 2019.

For more details see: EDQM




Posted by Dr. Tim Sandle