Wednesday 31 August 2016

Breakthrough for Patient Safety in Healthcare Facilities

By Megan Ray Nichols

Infection control is one of the most important aspects of health care, and it’s often the most difficult to manage. No matter how carefully cleaned a room, table, or piece of equipment is, everyone who passes by or touches it is constantly shedding microbes and bacteria, making it is easy to contaminate even the most sterile environment. A new study in infection control and sanitation procedures may help change that, providing an entirely new level of patient protection.

Time Is of the Essence

There are quite a few effective procedures currently in place for patient protection and infection control. Strict hand hygiene rules, for example, reduce the patient-to-patient transmission of microbes, bacteria, and infections. Other techniques include environmental disinfection and a test for specific microbes or bacteria called point prevalence testing.

The big problem with this type of testing is the amount of time it takes. It utilizes a culture-and-swab technique to detect any potential pathogens. Collecting the swab only takes seconds, but it can take days or even weeks to grow a culture. While medical professionals wait for cultures to grow, a dangerous pathogen can spread throughout a facility.

Not Everything Is Disposable

One of the easiest ways to deal with bacterial flora in a medical facility is to use of sterile, single-use disposable tools and items — such as the swabs, scalpel blades, and needles you see every time you visit a doctor’s office. They’re designed to be properly discarded after each use.

What about the stuff that can’t be thrown away or tools that are not single use? There are 6 steps to follow to clean, sterilize, package and store items that are not disposable:

1. Cleaning: Doctors clean tools manually then, clean them again using ultrasonic cleaners or automatic washers.

2. Inspection: Hospital staff visually inspects tools both for cleanliness and to make sure they work properly.

3. Packaging: Tools need to be packed in pouches, wrapped, or stored in rigid containers prior to sterilization.

4. Sterilization: There are a variety of means to sterilize packaged tools. Steam autoclave sterilization is the most common method — it’s both successful and cost effective.

5. Storage: After sterilization, storage must be in an area that minimizes the chances of contamination. Low traffic areas in a temperature-controlled office are ideal for this.

6. Quality Control: Doctors use physical, biological, and chemical indicators ensure the tools remain sterile during storage and eventual use.

The Importance of Calibration

The successes of sterilization steps are heavily dependent on one important factor: whether the sterilization machine is functioning properly.

Let’s look at an autoclave machine as an example. Depending on the tools being sterilized, there are pressure, temperature, and time variables to consider when using an autoclave machine. Older machines might require you to set those variables manually, while newer computer controlled autoclaves set automatically, hence the need for equipment calibration.

When calibrating a machine, an engineer or the machine itself will run a series of tests to make sure that the pressure, temperature and time are all within acceptable parameters. Without calibration, you may find yourself using a less-than-sterile tool, wrongly assuming the autoclave functioned properly.

Advances in Sanitation Procedures

An ounce of prevention is worth a pound of cure — and that’s why a collection of Italian researchers spent time finding a way to more effectively detect potential problems in a medical environment. The key to this breakthrough comes from not focusing on the pathogens themselves, instead focusing on the entire microscopic ecology present anywhere there are human beings.

In this case, the researchers chose a dental office. Their test determined that the targeted microflora was present: mfDNA which lives in the mouth. They were also able to, after a surface was sterilized, determine if the sterilization was incomplete. The latter is something that traditional swab and culture tests fail to do.

The system isn’t perfect yet, but it’s most definitely a step in the right direction. With the proliferation of multi-drug resistant bacteria and viruses, advances in sanitation procedures and testing are vital to ensure that patients in any setting are as protected as possible.

Guest post by Megan Ray Nichols

Tuesday 30 August 2016

Contamination Control in Healthcare Product Manufacturing, Volume 4

A new edition of Contamination Control in Healthcare Product Manufacturing has been published. This is volume 4.

Contamination Control in Healthcare Product Manufacturing, Volume 4, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use of cleaning and disinfecting agents. There is something for almost everyone who has responsibility for developing or using microbiological contamination control programs and systems.

Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:

Regulatory changes relative to ISO 14644, Parts 1 and 2
Updates to ISO 11737-1
Risks of spores including preventive measures and disinfection
Utilities, surfaces and practices that impact cleanrooms
Cleanroom gowning and behavior
Regulatory guidance and how-to relative to handwashing
Contamination in water systems
Contamination in gaskets, drains, cooling systems and many other problem areas
And more including chapters covering Monitoring relative to USP <1116>, control limits, excursions, risk-based big data in aseptic processing and methods for effective use of Maldi-Tof

Tim Sandle has contributed two chapter to volume 4:

Sandle, T. (2016) ISO 14644 Parts 1 and 2 - The revised cleanroom standard and contamination control. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product Manufacturing, Volume 4, DHI, River Grove, USA, pp3-32

Sandle, T. (2016) Risk of microbial spores, prevention measures and disinfection strategies. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product Manufacturing, Volume 4, DHI, River Grove, USA, pp59-95

For details see: PDA

Posted by Dr. Tim Sandle

Monday 29 August 2016

Health infographic

Posted by Dr. Tim Sandle

Influenza alters the gut microflora

New study on respiratory viral infections and the gut

Influenza is one of the most contagious viral infections of the nose, throat and lungs. Symptoms include fever, extreme tiredness, sore throat, stuffy nose and muscle aches. Some infected people will also develop gastrointestinal symptoms such as nausea, vomiting and diarrhea; however, the molecular mechanisms involved are unclear. A new study in mice shows that influenza virus infection in the lungs alters the gut microbiota and immune responses via type I interferons.

Posted by Dr. Tim Sandle

All U.S. Blood Donations Should Be Screened For Zika

The Food and Drug Administration is recommending that blood banks screen all blood donations in the U.S. for the Zika virus. The expansion of testing won't happen all at once. The FDA is advising blood establishments in 11 states to begin testing within the next four weeks. Those states include Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.

Currently, Zika is being spread by mosquitoes in South Florida, Puerto Rico and the U.S. Virgin Islands, as well as most countries in the Caribbean and Central and South America. There are a total of 2,517 cases of Zika in the U.S. states and D.C., according to the Centers for Disease Control and Prevention, with 9,011 more in U.S. territories.

Posted by Dr. Tim Sandle

Saturday 27 August 2016

Candida auris

Candida auris is an emerging fungal pathogen, associated with bloodstream infections, wound infections and otitis, first identified as the cause of a hospital outbreak in England in 2015.

C. auris has been associated with bloodstream infections, wound infections and otitis. It has also been cultured from urine and the respiratory tract, although it is not known if positive cultures from these sites represent infections or colonisations.

To find out more, see: Public Health England.

Posted by Dr. Tim Sandle

An Overview Of IVC Filters: What Does Research Say?

By Michael Monheit

A 2013 editorial in the journal of the American Association questioned the existence of IVC filters that have been on the market for a very long time without proof of efficacy. The medical journal pointed out that IVC filters should work given that they work on the logic that you can prevent a traveling blood clot from reaching the lungs by catching it through placing a small wire net in the largest body vein.

America's largest manufacturers of IVC filters are Cook Medical and C.R. Bard who are credited for making seven different models, which include several that have been withdrawn from the market due to safety concerns. There has been a widespread use of these devices since their inception and have made their way to thousands of bodies.

Were The Devices Tested?

No member of the vast medical community could determine how effective the device was until 30 years after their invention when a French study was conducted between 1997 and 2005 besides a 1973 study. During this time, the manufacturers would come up with new features and ease the process of implantation for healthcare professionals.

The new designs were spurred by many studies that showed little benefits and serious long-term consequences associated with IVC filters that were designed for permanent implantation. Since the very first device to the present, the benefits of IVC filters remain completely untested which means they may be useless. states that the only clinical trial to assess the effectiveness of IVC filters done in 1973, revealed that they had no effect on ultimate mortality rates, but they would reduce the rate of pulmonary embolism

According to the US Food and Drug Administration (FDA) in 1979, approximately 2,000 IVC filters were implanted mainly to patients likely to suffer from a pulmonary embolism. 28 years later after numerous product redesigns, an estimated 167,000 patients had received IVC filters with an increased demand for the product.

Why Is There Legal Action Being Taken Now?

Despite IVC filters being widely accepted for many years, there has never been empirical evidence that shows that they perform the function they are being sold for. The previously mentioned French study was conducted on 400 patients with deep vein thrombosis, a lower limbs blood clot that can pass up to block veins in the lungs. This risk is usually referred to as pulmonary embolism and is what IVC filters are designed to prevent. Out of the 400, 200 were treated with only "standard anticoagulant treatments" such as warfarin while the other half were outfitted with IVC filters. Subsequently, for eight years the researchers recorded health outcomes and tracked the progress of patients.

The results revealed that IVC filters indeed lower the risk of pulmonary embolism (thus preventing blood clots from reaching the lungs). Twenty-four patients from the group without filters suffered from "symptomatic" PE, while only nine from the group with the filters did. Unfortunately, the devastating result was that patients with IVC filters were at an increased risk to develop deep vein thrombosis. It was apparent that filters would cause one of the conditions they were designed to treat.

FDA On IVC filters

Apart from facing several civil lawsuits, Cook Medical and C.R. Bard have been hit with several formal warnings from FDA. Bard has received a warning letter citing eight violations of FDA requirements, the worst violation being manufacturing and marketing IVC models not cleared for sale by FDA and failure to report serious complications to the FDA.

The FDA released an update of its 2010 safety communication in 2014 that retrievable IVC filters shouldn't be left for too long in patients and should be removed by doctors between 29 and 54 days after being implanted. Now there have been over 200 personal injury lawsuits that have been filed against Cook Medical, by patients who have suffered from the lack of medical research of the devices. Lawsuits have alleged that Cook marketed a defective medical device and falsely represented its efficacy and did not adequately warn the public of the potential dangers associated with it.

Author Bio:

Michael Monheit, the managing attorney at Monheit Law, has been working to assist individuals and families who have been harmed by defective drugs and products. In fact, Mr. Monheit served on the Plaintiff’s Steering and Executive Committee for MDL 1148. He understands how stressful it can be to stand up to a major corporation and is committed to making sure that plaintiffs know they have someone on their side.

Friday 26 August 2016

Identification of Listeria species, and other non sporing Gram positive rods

A systematic approach is needed to differentiate clinically encountered, morphologically similar, aerobic and facultatively anaerobic, non-sporing Gram positive rods.

A publication covering the identification of Listeria species, and other non sporing Gram positive rods, except Corynebacterium, has been issued by UK Standards for Microbiology Investigations (document SMI ID 3).

There are currently ten validly named species in the genus Listeria: L. monocytogenes, L. ivanovii, L. seeligeri, L. innocua, L. welshimeri, L. grayi, L. fleischmannii, L. marthii, L. rocourtiae and L. weihenstephanensis. Of these ten species, the first six can potentially cause infections in humans, albeit rarely in some cases.

Listeria species are short Gram positive rods, 0.4-0.5 x 0.5-2.0μm, with rounded ends, occurring singly or in short chains and occasionally appearing filamentous. Members of the genus are facultative anaerobes, non-sporing, non-acid fast and do not possess a capsule. Listeria species are motile by peritrichous flagella when grown at 20°C - 25°C and display a characteristic “tumbling” motility. The optimum growth temperature (but not for motility) is 30-37°C.

Colonies on blood agar are non-pigmented and may resemble those of β-haemolytic streptococci.

To access the publication see Public Health England.

Posted by Dr. Tim Sandle

Wednesday 24 August 2016

ISO 50001 on energy management under revision

Improving energy performance and reducing energy costs is one of the most important tasks that organizations throughout the world have to achieve. ISO 50001 on energy management can help organizations with this exercise.
Since its publication five years ago, ISO 50001 has gained much importance. In fact, nearly 7 000 organizations were already certified to the standard at the end of 2014.

ISO 50001, Energy management systems – Requirements with guidance for use, specifies requirements for establishing, implementing, maintaining and improving an energy management system. The aim is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, use and consumption.

After five years of existence, time has come to revise ISO 50001 to ensure it remains a useful tool for all types of businesses and organizations around the world.

For further details see ISO

Posted by Dr. Tim Sandle

Tuesday 23 August 2016

Standard to validate microorganism testing methods (food)

ISO 16140:2003 for the validation of alternative (proprietary) microbiological methods has just been revised. The new multipart standard provides a specific protocol and guidelines for the validation of methods both proprietary (commercial) or not. Proprietary methods are generally cheaper to use, produce results faster than traditional culturing methods and are simpler to perform as they require fewer technical skills. What’s more, most are partly or completely automated, so easier to use in less experienced laboratories, such as factory and commercial laboratories and with less technical human resources.

Two parts of ISO 16140 series now published

ISO 16140-1:2016, Microbiology of the food chain – Method validation – Part 1: Vocabulary, describes the terminology used in microbial testing, while ISO 16140-2:2016, Microbiology of the food chain – Method validation – Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method, is dedicated to the validation of proprietary microbiological methods. They are designed to help food and feed testing laboratories, test kit manufacturers, competent authorities, and food and feed business operators to implement microbiological methods. ISO 16140-2 includes two phases, the method comparison study and the interlaboratory study, with separate protocols for the validation of qualitative and quantitative microbiological methods.

Over a hundred alternative methods have been validated based on the previous version of ISO 16140, and the standard was updated to provide new insights on the validation of microbiological methods and experience gained from conducting validation studies across the world. Today, many alternative (mostly proprietary) methods exist that are used to assess the microbiological quality of raw materials and finished food products and monitor the microbiological status of manufacturing processes. The developers, end-users and authorities need a reliable common protocol for the validation of such alternative methods. With this new protocol, the data generated will also provide potential end-users with performance data for a given method, thus enabling them to make an informed choice on the adoption of a particular (alternative) method. This data can also serve as a basis for the certification of a method by an independent organization.

 “The validation according to ISO 16140-2 will lead to a higher reliability of the alternative method test result and the users will benefit from having microbiological test results available sooner. Most likely, this will contribute to greater food safety,” explained Paul in ‘t Veld, the Convenor of Working Group 3 on method validation (ISO/TC 34/SC 9/WG 3 whose secretariat is held by NEN, ISO member for the Netherlands) that is responsible for the development of the ISO 16140 series.

Posted by Dr. Tim Sandle

Monday 22 August 2016

Revised monocyte activation test chapter

During its 155th Session, held in Strasbourg on 21-22 June 2016, the European Pharmacopoeia Commission adopted a revision of the general chapter Monocyte-activation test (2.6.30) in order to make it more widely useable by stakeholders and thus facilitate a reduction in testing on live animals.

The MAT is suitable, after product-specific validation, as a replacement for the rabbit pyrogen test (RPT). The MAT offers significant advantages over animal testing: based on the human fever response, it provides a more relevant prediction of pyrogenic activity than the RPT, it can detect endotoxin and non-endotoxin pyrogens and is applicable to a greater variety of products than the RPT; moreover, it is more accurate as well as more cost- and time effective than the RPT.

For further details see: EDQM

Posted by Dr. Tim Sandle

Saturday 20 August 2016

Pharmeuropa reviews

Pharmeuropa 28.1 contains two draft monographs of interest:

2.2.2    Degree of coloration of liquids

This draft corresponds to Stage 4 within the Pharmacopoeial harmonisation process (Ph. Eur., JP, and USP). The coordinating pharmacopoeia is the USP.

0333                Heparin Sodium

Related substances: the proposal is to introduce a disregard limit to the related substances test, in line with the principles of general chapter 2.2.46 Chromatographic separation techniques. The current text does not specify a quantitative limit for ‘any other impurity’ and compliance with the acceptance criterion depends on the sensitivity of the method.

Pharmeuropa 28.2 contains two further draft monographs of interest:

1473    Soya-bean oil, refined

Identification: reference to the test for composition of fatty acids has been added since it is more specific than that for identification of fatty oils by TLC; the latter has been maintained as second identification.
Composition of fatty acids: the term ‘and isomer’ has been included in the limit for oleic acid since baseline separation of oleic acid and its more abundant positional isomer, cis-vaccenic acid, is not achieved with the current method

2034                Substances for Pharmaceutical Use

In line with the implementation strategy of the ICH Q3D guideline, a new paragraph on elemental impurities has been added to this general monograph. Its aim is to clarify requirements for substances for pharmaceutical use used for the production of medicinal products that are outside of the scope of general chapter 5.20 (which will be aligned with the ICH Q3D guideline). For medicinal products within the scope of general chapter 5.20, the limits for elemental impurities apply to the medicinal product.

In addition, a sentence has been added to the production section to highlight the need during risk assessment, to take any necessary account of potential elemental impurities derived from intentionally added catalysts and reagents.

Pharmeuropa is an online EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months. Comments received are processed by EDQM, at this stage the draft can be amended and republished. If no further revision is required the draft monograph is proposed to the European Pharmacopoeia Commission if adopted an implementation date is given and this is about one year after the adoption of the monograph.

Posted by Dr. Tim Sandle

Thursday 18 August 2016

eBook: Bioprocessing & Sterile Manufacturing

Pharmaceutical Technology's has a new eBook addresses a range of pressing bioprocessing and sterile manufacturing topics.

Features include a report on accelerated scale-up for vaccine production, a review of the new ISO 1464 Parts 1 and 2 standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement and drug shortages, and qualification and validation of single-use shipping systems.

For details see: Pharmaceutical Technology

Posted by Dr. Tim Sandle

Sunday 14 August 2016

Overcoming Pharmaceutical Shipping Challenges

By Megan Ray Nichols

Not too long ago, the only way a patient could receive prescription medications was to first visit their doctor and get a written prescription. Armed with that sheet of paper, the patient would then go to their pharmacy of choice and wait for it. It was a bit time consuming, but it got the job done. Today, those same patients can have their doctor email or fax a prescription and have it ready for pick-up.

People can also order medications online at discount prices. A prescription is still required, but now they are shipped across the country. These new methods of delivery put many more pharmaceuticals "out into the world." There are always huge shipments of the drugs dropped off at distribution centers for dispersal to the many hospitals and pharmacies around the clock.

All of which means more challenges for drug manufacturers and pharmacists with regard to shipping those drugs. Thankfully, the industry at large is on top of the situation and taking proactive steps to combat those challenges. The first part is to identify the concerns.

Increased Need for Security

An armored car used to transport money is a recognizable target for would-be thieves. It is also a heavily fortified target. Most armored vehicles don’t transport pharmaceuticals. That puts the medications at greater risk for theft.

Too often drug shipments that fall prey to robbery are the result of "inside" information. That is why many drug manufacturers have stepped up their logging procedures. They can track a shipment of pills similar to how UPS tracks a package. By following that shipment along every step of the delivery route, it becomes increasingly difficult for theft to occur. It also helps to modify those routes so familiar patterns aren't picked up on by nefarious robbers.

Safety While Shipping

Good portions of shipping costs are in the actual packing materials. For drug shipments, those materials often need to be temperature controlled, not only on the truck, but also in insulated bulk bags.

It doesn't make sense for a business to toss their shipping container after each use. That would cost them, and ultimately the consumer, more. Recycling bags through reclamation is vital to keeping shipping costs down. To reduce cross-contamination between products, each bag is thoroughly cleaned and inspected before release.

It’s important shipping does not compromise the vitality of those drugs.

Cold Storage Facilities

Just because a shipment of drugs coming from overseas has been protected on its journey, doesn't mean it will be protected upon delivery. The challenge for expanding markets in the pharmaceutical industry is to insure proper cold storage facilities meet with industry standards along every step of the way. This could put the responsibility on the drug manufacturer to conduct spot inspections of those ports.

Increase Regulatory Scrutiny

Regulatory boards from around the world have the option to change the "rules of the game" at any time. It might be that they consider liquid nitrogen a better way to keep drugs in cold storage than dry ice. It could be that new findings shorten the shelf life of certain drugs. This is where pharmacists and the drug makers need to work together to maintain compliance with these regulations.

In the end, these challenges could manifest in a disruption of prescription delivery. However, with proper care, storage, and security measures, patients should expect their deliveries to arrive on time, every time.

Guest post by Megan Ray Nichols

Special offers