Wednesday 30 August 2023

New species of marine bacteria that multiplies by a unique budding mechanism

 

The image shows Poriferisphaera hetertotrophicis, observed using Transmission Electron Microscopy (TEM). Image credit: Rikuan Zheng (CC BY 4.0)

Researchers have isolated a new strain of marine bacteria with unique characteristics from the ocean seabed. The bacterium multiplies by a unique budding mechanism and releases viruses to facilitate nitrogen metabolism.

The research advances scientific understanding of physiological mechanisms in deep-sea Planctomycetes bacteria, revealing unique characteristics such as being the only known species in the class of Phycisphaerae bacteria that uses a distinct budding model of division. 

Planctomycetes bacteria have blurred the lines between prokaryotes and eukaryotes. 

 

Planctomycetes bacteria possess several uncommon traits: a compartmentalized cell plan, an enlarged periplasm, a tightly folded nucleus-like structure, an endocytosis-like method of uptake, and a FtsZ-free method of cell division

The research provides convincing evidence that the new species is extensively involved in nitrogen assimilation and lives with a chronic virus (bacteriophage) that facilitates nitrogen metabolism. This bacteriophage – called phage-ZRK32 – was able to increase the growth of themarine bacterium dramatically by facilitating nitrogen metabolism.

Nitrogen cycling by bacteria is an essential process that frees up nitrogen for building into nucleic acids, amino acids and proteins – the building blocks of life.

The organism was isolated from sediment samples isolated from a deep-sea cold seep. The proposed name for the organism is Poriferisphaera hetertotrophicis.

The research appears in the journal eLife,titled "Physiological and metabolic insights into the first cultured anaerobic representative of deep-sea Planctomycetes bacteria".

[Image key: CM, outer membrane; Pi, cytoplasm; R, ribosome; N, nucleoid; ICM, cytoplasmic membrane; Py, periplasm; V, vesicle-like organelles]

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday 29 August 2023

New ISO standard: Airborne particle sampling techniques

 


The latest part of ISO 14644 was published last week (part 21). This covers particle counters (light scattering aerosol particle counters).

 

ISO/TR 14644-21:2023 Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques.


 

 

The main points of interest that I've picked out from the standard are:

  • The LSAPC should be situated lower than the sample height to avoid sampling upward through tubing.
  • It is best to avoid tubing if possible.
  • Tubing should be as short as possible. However, the standard acknowledges the complexities of fitting tubing in RABS and isolators for fixed counters. It recommends that a particle loss assessment be conducted.
  • Different isokinetic probes are recommended for counters of different flow rates e.g. 28 l/m vs. 50 l/m and in relation to different air velocities. The acceptable particle loss (sampling error) from the use of an isokinetic probe is up to 5%.
  • Guidance is provided on isokinetic probe orientation in terms of the number of degrees permitted (target of 00, no greater than 200).
  • For tubing materials, stainless steel is preferred, followed by Bev-a-line, with Tygon suitable for higher temperatures.
  • With tubing length, this should be less than 1 metre, although 2 metres could be justified for fixed particle counters in a RABS provided the number of bends does not exceed 1 ( ≥5.0 ┬Ám particle losses reach 20% at 2 metres (for 10 mm diameter tubing). If 2 or 3 bends are required, a risk assessment is needed.
  • With tubing bends, the larger the radius the better with 15 cm being the starting point (depending on the flow rate and diameter).

 

This part is formally linked to ISO 14644 parts 1 and 2 (and these parts form part of EU GMP).

The standard is available from ISO or via your national standards organization.

 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday 28 August 2023

Where to Turn for the Top Surgical Specialists


Accessing top surgical specialists is imperative for patients who require complex surgical procedures or are seeking to receive specialized care for their condition. Surgical interventions have transformed the field of medicine and have become an effective medical solution for a plethora of ailments and conditions. However, finding the right surgical specialist for your individual condition can be a daunting and challenging process. It requires extensive research, evaluations, and an in-depth understanding of the medical field. If you or a loved one are in need of surgical intervention, the following article provides valuable insights and resources to help you locate the top surgical specialists across the globe.

 

By Hannah Whittenly 


 

One of the best resources that you can leverage to locate top surgical specialists is the National Cancer Institute (NCI). The NCI lists comprehensive cancer centers across the United States. These centers have been recognized as leaders in cancer care, treatment, and research and have access to the latest technologies, surgical techniques, clinical trials, and multidisciplinary teams. Patients can be assured that the surgical specialists affiliated with these centers have the expertise, experience, and knowledge to deliver the best possible outcomes for their condition.

 

Another useful resource to consider is the American College of Surgeons (ACS). The ACS is the largest organization dedicated to improving surgical care and setting standards for surgical education. The ACS has a database of board-certified surgical specialists, which includes their specialties, academic qualifications, education, and training. By utilizing their database, patients can locate surgeons who have extensive experience in performing complex procedures and specialize in their specific medical condition.

 

If you or a loved one require specialized surgical intervention, pursuing a second medical opinion can provide additional insights and options. This can be essential, as patients may not be aware of all the available treatment options such as morpheus 8,  and a second opinion can assist them in making an informed decision. Additionally, patients can gain a clear understanding of the surgical procedure, potential side effects, and the recovery process involved in the surgical intervention.

 

Social media platforms and patient review websites can also be utilized to gain insights into surgical specialists' practices. Patients can read reviews, watch videos, and access testimonials shared by other patients who have undergone similar surgical procedures. These platforms provide valuable insights into surgeons' bedside manners, medical expertise, and patient outcomes.

 

In conclusion, accessing top surgical specialists is an essential aspect of receiving specialized and effective medical care. Patients must conduct extensive research, seek second opinions, and leverage multiple resources to locate the right surgical specialists for their individual condition. By utilizing resources such as the NCI and ACS, pursuing a second medical opinion, and leveraging social media platforms, patients can locate surgical specialists who possess the expertise, experience, and knowledge required for their unique medical condition. Remember, it is critical to work with a surgical specialist who can provide you with the best possible outcomes, thereby improving your quality of life.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Thursday 24 August 2023

How Your Pharmacy Can Navigate FDA Regulations


 

Navigating the FDA regulations can be a daunting task for many businesses, including your pharmacy. With increasing compliance demands, it can be easy to get lost in the regulations and risk fines or even risk losing your license. Therefore, it's crucial to understand how to navigate FDA regulations to ensure you're meeting compliance requirements. This article will share with you a few tips on how your pharmacy can navigate FDA regulations smoothly.

 

By Lizzie Weakley

 

Stay Up-to-Date with FDA Regulation Changes

The FDA regulations are always changing. Therefore, it's essential that your pharmacy remain up-to-date on the latest regulatory changes to ensure your business is meeting compliance requirements. It would be helpful if you subscribe to FDA emails and newsletters to stay informed of updates and changes, attend regulatory seminars, and training programs to stay current on best practices.

 

Conduct Regular Self-Audits

Conducting regular self-audits is a proactive way to ensure your pharmacy is in compliance with FDA regulations. This means identifying potential compliance issues and correcting them before the FDA does. During self-audits, consider FDA requirements in areas such as product labeling and advertising, prescription monitoring, and controlled substance processes.

 

Develop Compliance Programs

Your pharmacy can navigate FDA regulations more successfully by developing comprehensive compliance programs. This means designating roles and responsibilities, providing training to employees, and conducting audits of all aspects of your pharmacy operations. Through compliance programs, you can eliminate compliance risks by creating processes that align with FDA regulations.

 

Work with FDA Regulatory and Quality Compliance Experts

Pharmacies can benefit from working with FDA regulatory and quality compliance experts, like Compliance Insight, to navigate FDA regulations. These experts are knowledgeable about FDA regulations and can help your pharmacy remain compliant by conducting risk assessments, audits, and providing guidance on regulatory compliance issues.

 

Make FDA Regulations Part of Your Culture

Make FDA regulations a part of your pharmacy culture by creating and sharing a standard operating procedure manual with all employees. Ensure that all employees understand their roles and responsibilities concerning FDA regulations and make compliance a part of performance evaluations for all employees.

 

Navigating FDA regulations can be a challenging task, but with these tips, you can successfully navigate them and avoid penalties and risks. To summarize, it's important to stay up-to-date with FDA regulations, conduct regular self-audits, develop compliance programs, work with regulatory and quality compliance experts, and make FDA regulations a part of your company culture. By following these steps, your pharmacy can remain compliant and maintain trust with your customers.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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