Human skin, movement and particles within the cleanroom

 

Cleanroom microbiologists have a concern with particle release and the main source of particle release is from personnel and a proportion of these particles will be microbial carrying. With cleanroom gowns the fabric must be tightly and reliably woven, typically retaining particles of 6 to 12 μm and greater and the highest efficiencies of 90% or higher     , although this varies by gown and whether it is single use or reusable. Assessments are made using bioaerosol chambers. In selecting gowns of the optimal pore size, there needs to be a trade-off between operator comfort and the particle retaining capabilities. There are also variables to take account of, for young people despise more microorganisms than older people and biological males disperse significantly more bacteria than biological females .

 

When we disperse skin particles, the median size of these have a minimum projected diameter of 20 μm, although 7–10% are less than 10 μm (these expand in the hydrated state) and a few are less than 5 μm. Where corneocytes are dispersed, these are far larger in size and would always be retained by the cleanroom gown.

 

It is for these reasons that we need to wear protective cleanroom gowns, with pores that can capture a high proportion of these pieces of skin detritus. Fabric and garment design is intended to act as a filter to minimise contaminants from the operator, such as skin flakes, hair and sneezing aerosols, from entering the cleanroom.

 

It is also based on these sizes that microbiologists are concerned with particles of an approximate diameter of 5 μm or larger as these may be indicative of skin fragments.

 

We also know that rates of skin shedding are increased through excessive movement, which is why movements within cleanrooms need to be slow and steady and why, in aseptic processing rooms, we ask personnel to stand still foremost of the time. Minimum movement is essential to contamination control.

 

Finally, we also know that many skin conditions, such as those leading to dry skin, increase the rate of shedding which is why skin conditions need to be reported ahead of each shift and judgement made about whether or not an individual can go into the cleanroom. There is an additional concern that dry skin alters the homeostasis of the microbiome, leading to a greater abundance and therefore shedding of organisms that are atypical, such as anaerobic and organisms that thrive in anoxic environments, including Cutibacterium acnes.

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

4 Important FDA Regulations for Pharmacies

 Image: M. Belnap

As a pharmacy, you need to know the different FDA regulations that apply to your business. We will discuss four of the most important regulations pharmacies need to know about in 2022. If you understand and follow these regulations, you can help ensure that your pharmacy operates legally and safely.

By Megan Belnap

Drug Supply Chain Security Act (DSCSA)

Congress passed the Drug Quality and Security Act (DQSA) in November 2013. The Act aims to create a system that tracks prescription drugs throughout the supply chain in the United States. At the end of the day, the goal is to provide patients with safe and effective medications by preventing counterfeits from entering the supply chain.

The Lowest Price Act

The "Medicare Advantage and Part D Drug Pricing Transparency Act of 2018" became effective on or after January 1, 2020. This act prevents medical providers of Medicare Advantage plans and Medicare Part D prescription drug plans from employing gag clauses that prevent pharmacists from informing Medicare patients if their co-pays are different from those they would have to pay otherwise.

USP 800

A new USP 800 standard from the United States Pharmacopeial Convention (USP) requires changes to standard operating procedures (SOPs) across an organization to protect healthcare workers, patients, and the environment from accidental exposure to hazardous drugs (HDs). This regulation applies to all phases of HD handling, from receipt through disposal, and it covers both sterile and non-sterile compounding.

 

The regulation is based on existing best practices, so many organizations have already complied with it. However, certain SOPs will need to be updated to meet the new requirements. As an example, the storage area for HDs must now be ventilated, and those involved in compounding must always wear PPE. Also, surfaces in the compounding area need to be decontaminated regularly.

 

By following these and other new regulations, healthcare organizations can ensure the safety of their employees, patients, and the environment. To make sure your pharmacy meets the above regulations, a company like Compliance Insight can help you adhere to DSCSA requirements.

Resource Conservation and Recovery Act (RCRA) standards

The rule was released in the early months of 2019 to clarify how organizations are responsible for disposing of hazardous and controlled substance pharmaceuticals in waste streams. A new and updated set of requirements is included in the regulation for identifying, managing, and disposing of these pharmaceuticals. Employees are also required to be trained in the new procedures. Environmental protection and public health are important reasons for compliance with the regulation.

 

The new regulations are crucial for ensuring the safety of employees, patients, and the environment. To protect public health and maintain the quality of the drug supply, compliance with these regulations is essential.

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

Avoid These Mistakes When Applying For 420 Medical Evaluations

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There’s no denying that medical marijuana is growing in popularity. As legal restrictions loosen and access increases, more and more people are turning to cannabis as a natural, herbal alternative for treating their aches and pains. If you’re one of the many people who live in places where recreational or medical marijuana use is still illegal, or if you simply don’t want to go through the process of obtaining a medical marijuana license, it’s important to know how to avoid some of the more common mistakes when applying for 420 medical evaluations. This article will walk you through what needs to be done in order to make sure your application is approved, and successfully avoid mistakes that could end up costing you time and money.

By Laura Henry

Tips to make the process easier

If you have any medical issues, like hearing loss or diabetes, you may want to write them down in detail so that your doctor can address these issues during your appointment. Additionally, be honest about what medications you are taking and if you’ve taken them for longer than 6 months. A doctor needs to know these things to better help with finding an appropriate treatment plan. Finally, bring someone who is supportive and reliable with you to your appointment.

Choose the Right Doctor or Clinic

Doctors are not required to take special classes or pass any tests in order to be certified as medical marijuana physicians. While no doctor can guarantee that they will be able to get you a medical marijuana card, it is important to choose your doctor wisely. First, do some research and make sure that you’re choosing a doctor who has experience in evaluating patients for a cannabis card. If possible, schedule an appointment before deciding which doctor to see so that you can meet with them personally and ask about their qualifications first-hand. Be wary of clinics that seem too eager for your business. If a place seems sketchy, avoid it at all costs!

Make Sure to Fully Fill Out Your Application

The government is taking steps to crack down on patients who are applying for a 420 evaluation in order to purchase recreational marijuana instead of medicinal. To do so, they will be checking that patient’s answers very carefully. For example, if you indicate that you have chronic pain or PTSD on your application, then it is imperative that you fully describe how these conditions affect your daily life and how cannabis use helps address them. The main points that you must cover in your application are:

 

●     Why do you believe cannabis is a medication for you?

●     How long have you suffered from your condition(s)?

●     What treatments did not work for you?

●     How does cannabis help treat your symptoms?

●     Do medical marijuana facilities/dispensaries provide better service than what physicians can provide?

●     How would access to cannabis as a medicine impact your life?

●     If accepted, how would it change your life (relationships, finances, living arrangements)?

●     Will using medical marijuana impair or interfere with work or social activities that are important to you?

●     List all other medications that will continue to be used.

 

You can also expect physicians to check whether or not you really need medical marijuana based on what prescriptions you currently take and any other medical conditions for which you have been treated recently. So when answering questions about prescription drugs, make sure that everything is correct!

Know What to Expect During the Appointment

It’s always a good idea to know what to expect before your appointment. In many states, medical marijuana evaluations are required for all patients prior to being approved for a medical marijuana license. Patients may need to schedule their evaluation months in advance of when they actually need it, so it’s important to understand what kind of information will be necessary during your appointment and what you should do if you live in a state that requires a visit with an actual doctor. The specifics can vary greatly depending on where you live.

Figure Out the Timeline for How Long It Takes

There are two different deadlines for medical evaluations. There is a 15-day timeline to apply and a 3-month timeline to be approved. Start by getting your application in as soon as possible and you’ll avoid a penalty. The faster you get your application in, you will know whether or not you have been approved earlier. So start today! Write everything down: This can save you from missing an important deadline and could also help if there is any confusion about when something needs to be done. Keep notes on your progress with each step so that it will be easier for someone else to pick up where you left off. You don’t want to lose any time because of miscommunication or poor organization along the way; plan accordingly!

Gather as Much Information as Possible

A huge mistake many first-time medical cannabis applicants make is not doing their homework and being prepared. Make sure you collect as much information as possible including, but not limited to: your local municipality’s guidelines on cannabis, state-by-state laws related to medical and recreational marijuana, where doctors are qualified to issue medical marijuana recommendations in your area (as well as how and how often they can), whether or not there are prerequisites for receiving a card such as age or residency, what types of security systems need to be in place if you plan on growing at home, dispensary information such as hours of operation, preferred types of payment, pricing, and more.

 

 

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