Friday 30 December 2016

Sodium hypochlorite: health effects, incident management and toxicology

Sodium hypochlorite is a commonly used disinfectant and sanitization agent. The U.K. government has recently updated safety information relating to use of the chemical.

Key points from the review are:
  • sodium hypochlorite is a green/yellow liquid with the characteristic smell of chlorine
  • it is a major ingredient in household bleach (present at up to 10%)
  • it is also used as a disinfectant for swimming pools, can be used to disinfect drinking water, in some medical treatments and in the manufacture of paper and pulp
  • accidental skin or eye exposures to sodium hypochlorite in domestic products are common
  • children may be exposed to sodium hypochlorite in bleach following accidental ingestion
  • mixing sodium hypochlorite bleach with other cleaning products may produce dangerous gases  ingestion of small amounts of household bleach is unlikely to cause any serious or long term health effects
  • ingesting large amounts of household bleach or any amount of industrial strength bleach is more likely to cause serious health effects

Further information can be found here.

Posted by Dr. Tim Sandle

Wednesday 28 December 2016

Cleanroom Microbiology

There are books about cleanrooms and books about microbiology, but rarely are these two key subjects relating to contamination control brought together. The book 'Cleanroom Microbiology' applies the latest best practice to pharmaceuticals and healthcare.

For further details, please see the flyer below or go directly to the PDA Bookstore.

Posted by Dr. Tim Sandle

Tuesday 27 December 2016

Modern Approaches to Pharma Cleanroom Design

The performance of a cleanroom is defined by a set of complex interactions between the airflow, sources of contamination and heat, position of vents, exhausts, and any objects occupying the space. Consequently, changes to any of these elements will potentially affect the operation of the cleanroom and could invalidate aspects of the room design.

With cleanrooms used in the pharmaceutical industry, there are additional considerations aimed at minimizing contamination. These are centered on the idea that cleanrooms should be constructed in a way which makes them easy to clean and disinfect.

This is an extract from an article written by Tim Sandle for Controlled Environments magazine. To access the full article, see CE.

Posted by Dr. Tim Sandle

Monday 26 December 2016

Cleanroom Cleaning and Disinfection: Eight Steps for Success

Cleanrooms in healthcare and pharmaceutical facilities must be kept in a state of microbiological control. This is achieved in a number of ways, including the physical operation of Heating, Ventilation, and Air Conditioning (HVAC) systems, control of materials, properly gowned and trained personnel, and through the use of defined cleaning techniques, together with the application of detergents and disinfectants.

The object of cleaning and disinfection is to achieve appropriate microbiological cleanliness levels for the class of cleanroom for an appropriate period of time. Thus the cleaning and disinfection of cleanrooms is an important part of contamination control.

In an article for Controlled Environments magazine, Tim Sandle examines eight key steps to be followed, in relation to cleaning and disinfection, in helping to keep cleanrooms “clean.”

To view the article, see CE.

Posted by Dr. Tim Sandle

Sunday 25 December 2016

Better Data Integrity

Guest post on data integrity -  by Natalia Román López, Mettler Toledo
One of the primary motives driving organizations to purchase a laboratory information system (LIMS), electronic lab notebook (ELN), or laboratory execution system (LES) is the appeal of connecting laboratory instruments for electronic data collection. When a laboratory instrument is directly connected, costs in time, labor, and potential error associated with manual data transfer are essentially eliminated. However, even with the compelling advantages, many instruments and systems still remain disassociated with data entry and transfer largely handled manually.
Manual data transcription and report creation keep laboratory users from focusing on his or her science. Frequently, transcribed data lacks certain elements as well as the traceability needed to satisfy internal quality management or regulatory mandates. The end result is loss of time and revenue as time is lost gathering missing data, re-transcribing results, documenting missing controls, and preparing reports. Additionally, laboratory staff must often comply with standard operating procedures (SOPs) for each analysis and document the entire process as well.
More than aggregating results
To the SOP point, while many labs have turned toward LIMS and ELN systems with the idea of replacing the manual workflow, the fact remains that these systems are designed primarily to aggregate data from an array of analytical tests, not to automate and document bench-top workflows or bind instrument metadata with results for traceability purposes. Yet these are the aspects of a truly integrated system that can deliver heightened SOP adherence, easier workflow management and better traceability.
What is needed is a ready-made, configurable solution that drives the workflow SOP directly through the balance or instrument, delivering automatic, integrated instrument management and data capture, allowing to focus on the analysis. The instrument control and workflow support provided by such a system forms an ideal foundation to the IT hierarchy. This layer interacts on a unidirectional or bi-directional basis with the others using standardized integration approaches, offering a practical, cost-effective, single-system solution for managing instruments that can be integrated with a lab's core scientific system such as an ELN or LIMS.
In essence, centrally maintained SOPs are driven to respective instruments to guide measurement and store all raw and processed data with corresponding metadata sets for future analysis.
Flexible data management
In a system of this type, no computer or tablet PC is needed on or near the bench top. The balance or instrument touchscreen is able to deliver real-time, step-by-step guidance to the user according to SOPs using flexible workflow tools that take advantage of instrument-specific firmware. When ready to begin, the operator simply touches a shortcut or selects a workflow from the instrument. As noted, this type of bench-top management system eliminates significant error potential that comes both with routine performance of SOPs and manual data entry.
Typically, generated reports can be communicated directly to the oversight lab informatics system (LIS). Information can also be drop-transferred to an open Excel cursor, making all metadata immediately available for analysis. Metadata can also be exported as a .csv or XML-formatted file. Finally, using API web services, extensive data sets can be exchanged bi-directionally with a platform of this type and other software systems, instruments and mobile devices. This, in effect, creates one functional system for truly flexible processing.
A two-way (data) street
Perhaps most importantly, this two-way street offers more than just results-management. It allows the sending of product data and sample series data from the lab informatics system (LIS) to the instrument. Information can be imported from a file location and exported to an open folder. This creates seamless instrument and task control, as seen in the graphic below:
As described, this kind of robust communication of workflows, transfer of results and immediate access to metadata eliminates manual transcription and transcription error-checking (the so-called “four eyes” principle). The elimination of a paper process also assures a coherent audit trail. This makes it easier for labs in regulated industries to comply with Good Laboratory Practice, Good Manufacturing Practice and Food and Drug Administration guidelines and standards.
An easier, faster process to operate instruments
In addition to compliance enhancements, common processes become easier and faster. A process starts when a user selects a substance to be handled then logs onto the system at the instrument touchscreen. There is no need to log onto a separate workstation to access each instrument, allowing single point process strat. All actions and results are recorded in the database against the user’s identity, using a time and date stamp. An attached printer can produce a label for the sample in process that contains requisite quality or regulatory information such as identity, concentration, and expiry date. The process can be further simplified if enabled for an attached barcode reader.
In conclusion, integrating instrument control software with informatics systems using .csv files, XML structures or API web-services closes gaps in traceability, simplicity, and efficiency. This lets labs take full advantage of instrument technology which, in many cases, already resides on their bench top to generate improvements in results tracking, quality compliance, data integrity and workflow efficiency.
Download the 'Data Integrity' guide.

Hydrogen chloride/ hydrochloric acid: health effects, incident management and toxicology

Hydrogen chloride/ hydrochloric acid is a commonly used in laboratories. The U.K. government has recently updated safety information relating to use of the chemical.

Key points from the review are:

  • hydrogen chloride is a colourless or slightly yellow gas
  • hydrogen chloride gas dissolves readily in water to give hydrochloric acid
  • it has many industrial uses, is found in consumer products and may be used in swimming pools to alter the pH
  • low levels of naturally occurring hydrogen chloride may occur in the air, however most is removed by the rain; it is also produced by some human activities
  • hydrogen chloride is highly irritating and corrosive breathing hydrogen chloride for a short period of time can cause irritation to the nose and throat, causing coughing and shortness of breath
  • higher concentrations can also cause headache, fever wheeze, a rapid heart rate and confusion; in serious cases the airways and lungs may be damaged
  • hydrogen chloride gas can form hydrochloric acid on the skin which is highly irritating and corrosive
  • hydrochloric acid solutions are highly corrosive and can cause skin burns on contact; they may also damage the eyes
  • drinking hydrochloric acid will burn the mouth, throat and stomach
Further information can be found here.

Posted by Dr. Tim Sandle

Saturday 24 December 2016

Season's Greetings

No matter where you are in the world or which belief system you subscribe to, as the year draws to close, I'd like to wish you all the best for the holiday period. Thank you for supporting Pharmaceutical Microbiology.


Tim Sandle

For the microbiologist - gifts Under $20.00
3.   Lab Equipment Cookie Cutters ($6.21 – $13.90,
4.   E. faecalis on SBA and E.coli on EMB Soap ($7.00,
7.   Microbiology Coasters ($10.50 – $11.95,
10. Agar Plate Necklace ($12.47,
12. Growth Bandana ($15.95,
16. The Invisible ABCs Children’s Book, By Rodney P. Anderson  ($19.95,

Tuesday 20 December 2016

Risk Assessment and Management for Healthcare Manufacturers

Risk assessment is a core requirement for pharmaceuticals and healthcare. One difficulty with implementing risk methodologies is in taking abstract tools and applying these to 'real life' situations. This is where the new book "Risk Assessment and Management for Healthcare Manufacturers" comes in. The book is packed full of case studies, illustrating how FMEA, HACCP, 5Whys and a range of other tools can effectively be applied.

For details about the book, please see the flyer below or go directly to the PDA Bookstore.

Posted by Dr. Tim Sandle

Monday 19 December 2016

PDA Europe Pharmaceutical Microbiology

PDA Europe 8th Conference on Pharmaceutical Microbiology,Porto, Portugal on 14-15 February 2017.

The conference theme will be “Microbiology in Pharmaceutical Manufacturing” and a comprehensive scientific program will include presentations from regulatory, industry and technology representatives from around the world.

The conference program is tailored to address the current issues and opportunities our industry faces every day. For example, topics of interest will include how to maintain process water systems to prevent contamination and biofilms, how to validate new technologies and microbiological methods, prevention of contamination in sterile and non-sterile products, and of course, new trends in endotoxin testing.

Posted by Dr. Tim Sandle

Good Manufacturing and Distribution Practice Inspectors Working Group

The European Medicines Agency has published a report titled “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015”.

The report provides an overview of the activities of GMP inspectors across Europe. As the report indicates: “This document is the annual report of the GMP/GDP Inspectors Working Group (GMDP IWG) for the year 2015. This group was established at EMA in 1996.

The GMDP IWG provides input and recommendations on all matters relating directly or indirectly to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The GMDP IWG focuses on harmonisation and co-ordination of GMP and GDP related activities at EU level. The group's role and activities are described in more detail in its mandate, which was revised in 2013. This annual report is set out in line with the format and objectives of the 2015 work plan.”

The report can be accessed here.

Posted by Dr. Tim Sandle

Saturday 17 December 2016

Containment Laboratory Glossary

Bioquell have put together a series of reference guides that contain:
  • A glossary of common terms and acronyms;
  • A selection of useful links to HSE, other regulatory bodies
  • Links to appropriate industry bodies.

To view the guide, see Bioquell.

Posted by Dr. Tim Sandle

Microbial Risk and Investigations

Book feature - 'Microbial Risk and Investigations'.

The investigation of microbiological laboratory findings (a.k.a. microbiological data deviations - MDD) - is of great importance for understanding the root causes of contamination and for assessing the risk on products, processes and environments.

The new book, edited by Karen Zink McCullough and Jeanne Moldenhauer, provides comprehensive coverage of microbiological investigations and is a must read for microbiologists and quality assurance personnel. 

Please see the flyer below or go directly to the PDA bookstore

Posted by Dr. Tim Sandle

Friday 16 December 2016

Antibiotic awareness: important messages on antibiotic use

Public health England have produced a document explains how to use antibiotics responsibly for patients, animal keepers and pet owners, and prescribers.
  • Antibiotics are essential medicines for treating bacterial infections in both humans and animals
  • Antibiotics are losing their effectiveness at an increasing rate
  • Bacteria can adapt and find ways to survive the effects of an antibiotic. They become ‘antibiotic resistant’ so that the antibiotic no longer works. The more you use an antibiotic, the more bacteria become resistant to it
  • Antibiotics should be taken as prescribed, never saved for later or shared with others; it is important we use antibiotics in the right way, the right drug, at the right dose, at the right time for the right duration. Appropriate use of antibiotics will slow down the development of antibiotic resistance
  • There are very few new antibiotics in the development pipeline, which is why it is important we use our existing antibiotics wisely and make sure these lifesaving medicines continue to stay effective for us, our children and grandchildren 
The information can be found here.

Posted by Dr. Tim Sandle

Wednesday 14 December 2016

Identification of aerobic actinomycetes

Most actinomycetes are typically Gram positive, filamentous, partially acid-fast, branched bacteria that have many microbiological characteristics in common with members of the genera Mycobacterium and Corynebacterium. The major groups of the order Actinomycetales, are actinoplanetes, maduromycetes, nocardioform actinomycetes, and streptomycetes.

Public health England has updated the protocol for the identification of aerobic actinomycetes.

The pathogenic genera within the aerobic actinomycetes are Nocardia, Actinomadura,
Streptomyces, Rhodococcus, Gordonia, Tsukamurella and Tropheryma whipplei.

The revised document can be found here.

Posted by Dr. Tim Sandle

Tuesday 13 December 2016

Why You Must Make Calibration Essential in Your Pharmaceutical Facility

Calibration is the method of setting a measuring device by adjusting it with a known accuracy, also called as standard. This technique determines if an instrument or device is producing accurate and measurable results within the specified limits as compared to those produced by a traceable standard over an appropriate range of measurements.

With calibration, you achieve 2 main objectives:

a)    Checking the accuracy of an instrument
b)    Determining the traceability of the measurement

If the equipment and instruments you use are not regularly calibrated, you risk reducing their consistency, quality and safety.

Why is Calibration Necessary

Even if the instruments produce accurate measurements today, you cant be assured of accurate measurements over a period of time. You will observe a driftin the readings which is a shift from the specified limits. Factors such as overuse, environmental and external factors such as electrical and mechanical shocks, and wear and tear causes a drift. Calibration helps in minimizing these uncertainties and eliminating drift right at the beginning instead of letting it become significant. Calibration helps in controlling and quantifying uncertainties and errors to an acceptable level. It also helps in improving the accuracy of the measuring device, thus improving the quality of the end product. With calibration you can be confident in your results which you can record, control and monitor.

How Frequently Should You Calibrate

There is no correct answer to how frequently should you calibrate?. Different instruments have different calibration needs. If you dont calibrate frequently, the measurements will suffer; at the same time calibrating too frequently isnt ideal as it is expensive. Let us look at 7 different factors that help in determining the calibration frequency.

1.    Consider the criticality of the measurement location. You must calibrate more critical locations more frequently as compared to the less critical locations.

2.    Keep a check on the operating conditions and workload of the instruments. Those taking a lot of workload or operating in tough conditions must be calibrated more frequently.

3.    Check the frequency of calibration the equipment required in the past. The stability history of the instrument will give you a good idea on how to plan and schedule calibration.

4.    Calibrate an instrument before you have to take extremely important measurements.

5.    If sudden unforeseen events, such as electric fault, extreme weather conditions or damage to the instruments due to an impact or falls occur, conduct a calibration process immediately.

6.    If you think that there are any discrepancies in the final product or if there is a visible shift from the acceptable criteria, it means you have to calibrate that instrument. Small variations are normal but if it crosses the acceptable limit, calibrate immediately.

7.    Adhere to the timelines and frequencies suggested by the instrument manufacturer.

Risks of Not Calibrating Frequently

You couldnt be more wrong if you think that it wont matter if you skip one calibration schedule or that frequent calibration isnt necessary. If you do not calibrate regularly, you may face one of following 4 issues:

1.    You will see numerous discrepancies and faulty readings in the final product, which will compromise the overall quality of the product.

2.    In every pharmaceutical product, safety is absolutely essential. If the product isnt safe to use or lies low on quality, you can put thousands of lives at risk. Using non-calibrated instruments will almost always cause wrong measurements of raw materials while producing medicines or sensitive instruments such as thermometers, causing safety threats to the consumers.

3.    When you use non-calibrated instruments, your end product will show discrepancies. This would mean that you will have to shut down the concerned processes and conduct a complete recalibration, increasing downtime. When you calibrate equipment regularly, the downtime will be minimized. Furthermore, it will also help you identify warning signs before they cause any significant damage to the end product.

4.    If the consumers receive subpar medical products, they will ask for a refund or even press legal charges against your company due to the damage caused to them. You wont just lose money but also put your reputation at risk. You may even face product recall, which is an expensive affair. The risk of litigation increases significantly if you use do not calibrate your equipment frequently.

What are the Instrument Calibration Regulations

There are numerous instrument calibration requirements that pharmaceutical companies must adhere to. In Europe, industry calibration requirements fall under the jurisdiction of the EMEA (European Medicines Agency), as well as local legislation, and in the US, the FDA oversees it. You must keep your calibration records up to date and ensure that you execute instrument calibration to the exact standards of written and approved procedures. Keep a master history record of every instrument in the plant. All the instruments must have a unique ID and all the product, process and safety instruments must be physically tagged and color-coded.
Set a calibration period and error limits for each instrument, which should tally with national and international standards. Ensure that they are more accurate than the required accuracy of the equipment being calibrated. Train your team properly and make sure they are competent to execute various calibration tasks and provide documented evidence of this.

Author Bio: Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines. He also invites people to visit his company to learn more about the type of calibration work he does.

Sunday 11 December 2016

What Are Probiotics?

Probiotics are live bacteria and yeasts that are good for your health, especially your digestive system. We usually think of bacteria as something that causes diseases. But your body is full of bacteria, both good and bad. Probiotics are often called "good" or "helpful" bacteria because they help keep your gut healthy.

Probiotics are naturally found in your body. You can also find them in some foods and supplements.

It's only been since about the mid-1990s that people have wanted to know more about probiotics and their health benefits. Doctors often suggest them to help with digestive problems. And because of their newfound fame, you can find them in everything from yogurt to chocolate.

For further details, see WebMD.

Posted by Dr. Tim Sandle

Top 25 Microbiology Blog and Website List for Microbiologists

This blog - Pharmaceutical Microbiology - has been named one of the 25 best microbiology blogs by Anuj Agarwal (Founder, Feedspot).

Here are the top ten blogs:


Microbiology on Google News

Microbiology on Google News
About Blog - Comprehensive up-to-date news coverage about Microbiology, aggregated from sources all over the world by Google News.
Frequency - about 2 posts per week


American Society for Microbiology - Education Blog

American Society for Microbiology - Education Blog
Washington, DC
About Blog - The American Society for Microbiology (ASM) is the oldest and largest single life science membership organization in the world. ASM’s education blog is a collection of content aimed at science educators and covers topics ranging from engaging your students in a K-12 setting to curriculum guidance in a university setting.
Frequency - about 1 posts per week


Microbiology Nuts & Bolts - The Bug Blog

Microbiology Nuts & Bolts - The Bug Blog
About Blog - Goal of this blog is to educate and empower doctors and healthcare professionals to understand microbiology and infection. Promote understanding of micro-organisms and how they cause infection, ensure appropriate choices when prescribing antibiotics, enable best practice for infection control management and ulimately provide better patient care.
Frequency - about 1 posts per week


Microbe Post | Microbiology Society Blog

Microbe Post | Microbiology Society Blog
London, UK
About Blog - A blog from the Microbiology Society. The Microbiology Society (formerly Society for General Microbiology) is a membership organisation for scientists who work in all areas of microbiology. It is the largest learned microbiological society in Europe with a worldwide membership based in universities, industry, hospitals, research institutes and schools.
Frequency - about 1 posts per week


Microbiology | Microbiology Society Journals

Microbiology | Microbiology Society Journals
London, UK
About Blog - Publishing high-quality research since 1947
Frequency - about 126 posts per week


Microbiology |

Microbiology |
About Blog - Discussion on Microbiology from Microbiologists on
Frequency - about 11 posts per week


Virology | Microbiology Society Journals | Journal of General Virology

Virology | Microbiology Society Journals | Journal of General Virology
London, UK
About Blog - Publishing high quality journal at the forefront of virology
Frequency - about 189 posts per week


Pharmaceutical Microbiology

Pharmaceutical Microbiology
About Blog - The blog details the latest microbiology news, training, updates to international standards, GMP and regulatory compliance, book reviews and so on. The subjects are pharmaceutical microbiology, contamination control, cleanrooms, as well as more general quality control, quality assurance, pharmaceutical, medical device, cosmetic, food and healthcare issue.Edited by Dr. Tim Sandle (established 2010)
Frequency - about 8 posts per week


Medical Microbiology | Microbiology Society Journals | Journal of Medical Microbiology

Medical Microbiology | Microbiology Society Journals | Journal of Medical Microbiology
London, UK
About Blog - The full breadth of Clinical Microbiology
Frequency - about 119 posts per week


Microbiologics Blog – Where Microbiologists Go To Grow

Microbiologics Blog – Where Microbiologists Go To Grow
St. Cloud, Minnesota
About Blog - The Microbiologics Blog was created as an educational hub where our fellow microbiologists can find current and useful information about industry news, technical tips and advice, as well as fun and fascinating content microbiologists can relate to and learn from. Our mission is to provide the highest quality biomaterials for a safer, healthier world.
Frequency - about 1 post per week

The full listing can be found here.

Posted by Dr. Tim Sandle

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