AS9100 vs. ISO9001: Which one is better?

 

Quality is a crucial part of almost every business but these measures become even more essential when it comes to the aerospace sector and defense sectors. When quality management is not done right in either the defense or aerospace sector many lives can be at stake. 

 

By Sam Andrew

 

Understanding the importance of quality management is very important in any organization because it is linked to almost every aspect of the company. From manufacturing to delivering products successfully to the customers quality management plays a role at every level. To maintain this quality in any organization two standards are known worldwide ISO9001 and AS9100. In this blog, the differences between these standards are explored which can help you identify which standard can work best for you.

 

What is AS9100?

AS9100 is a quality standard that is specially designed to fulfill the quality requirements of the aerospace sector and it is often referred to as the extension of the ISO9001 standard. This standard is supposed to be enhanced in comparison to ISO9001 and is based on the objective of ensuring, that services and products in the aerospace industry meet the highest quality standards. 

 

What is ISO9001?

ISO9001 is a globally known standard when it comes to managing quality in any organization. This standard is not industry-specific but is applicable to every industry and includes a framework to enhance the overall quality. This standard is also considered as the fundamental requirement of quality and principles in this standard are focused on the requirements of customers and motivate management. The goal of this standard is to make sure customers get the best quality services and products and by doing so, it benefits the businesses. Companies can become ISO Certificate Training Services after detailed training and passing the audit. 

 

Now let’s focus on their differences based on the following measures:

 

Industry focus

AS9100 is industry-specific and is designed to meet the requirements of the aerospace sector only. Whereas, ISO9001 is designed to meet the requirements of every industry and work as a general standard to maintain quality. 

 

Requirements

When it comes to implementing AS9100 in the aerospace industry, requires detailed quality control measures to ensure the levels of safety and production quality. Whereas, ISO9001 is a general framework that is required to be implemented and is based on less specific requirements when it comes to a specific industry.

 

Regulatory compliance

AS9100 is based on international regulations and standards such as based on the regulations of the EASA European Union Aviation Safety Agency. On the other hand, ISO9001 does not have specific reference to the regulations which makes it less specific.

 

Risk management

Risk management for the AS9100 is tailored and considered strictly to meet the requirements of the aerospace sector. On the other hand, ISO9001 promotes risk-based thinking that is not industry-specific but based on the overall guidelines and scenarios.

 

Product Safety

AS9100 has a strong impact on product safety based on the sensitive nature of the aviation sector and requirements. Whereas ISO9001 is all about the organizational measures and requirements but is quite general when it comes to the safety of the products. 

 

Managing suppliers

AS9100 pays huge attention to supplier management and focuses on the quality of the materials to ensure the safety of the aerospace sector. On the other hand, ISO9001 offers a huge set of guidelines that can help with evaluating suppliers in any industry.

 

Both are related

It is already mentioned above that AS9100 is derived from the ISO9001 which means that every clause in the ISO9001 is followed in the AS9100 which makes both standards quite identical but still, there are some differences that are discussed above. ISO is known as the base standard and it provides a direction for the organizations to refine their methods of delivering quality to their customers. 

 

Both standards are based on the following measures inside the organization when it comes to delivering quality.

 

Prioritize customers

Identification of the requirements of the customers is considered the most important part of the quality standards because, in the end, every organization needs to satisfy its customers. 

 

Organizational leadership

Maintaining strong leadership in an organization is an effective way to balance and manage quality in any organization. 

 

Employees

Employees are the backbone of any business, training them and engaging them at every level is the top priority of every quality standard either ISO9001 or AS9100. 

 

Process approach

Defining clear processes can lead to improved quality in any business sector. 

 

Continuous improvement

Quality standards aim to bring improvement continuously so that organizations become able to maintain their position in the fast-growing market, especially when it comes to the aerospace sector. 

 

Decision making

Quality standards focus on the collection and analysis of the data which can be an effective way to promote correct decision making and can help with mitigating risks. 

 

Supplier management

Analyzing and managing suppliers can have a huge impact on quality because it can also lead to better cost management. 

 

Conclusion

This article has discussed both standards along with their differences and their requirements. It can be concluded that both standards are essential when it comes to managing quality in an organization. 

 

AS9100 is an industry-specific standard that is specially designed to fulfill the requirements of aerospace and defense companies because of their specific needs and sensitive nature. 

 

Whereas, the ISO9001 standard is a universal quality standard that can be applied in any industry and can meet the quality requirements of the sector. Understanding the differences between both standards can be helpful for you because it can help you choose intelligently. AS9100 can also be tailored to meet your organization’s specific needs so, choose wisely and meet the quality requirements of your business.

 

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

4 Signs You Should See a Stomach Doctor

 

Our digestive system is responsible for breaking down the food we eat into nutrients the body can use for energy and growth. However, when our digestive system runs into problems, it can affect our overall health and well-being. Symptoms such as abdominal pain, diarrhea, and constipation can be frustrating and even debilitating. If you have been experiencing any of these symptoms or other abnormal signs, it may be time to see a stomach doctor.

 

By Hannah Whittenly

 

Gastrointestinal problems such as acid reflux, irritable bowel syndrome, inflammatory bowel disease, and peptic ulcers can all cause uncomfortable symptoms that require medical attention. If left untreated, they may escalate into more severe health issues. Here are four signs that indicate you should see a gastroenterologist.

 

Chronic Abdominal Pain

 

If you experience chronic abdominal pain, it could be a sign of an underlying issue like gastritis or an ulcer. Generally, stomach pains after meals that last over an hour should not be ignored. The pain intensity can range from mild to severe impacts on your work and activities. Consulting with a stomach doctor helps alleviate the underlying problem.

 

Consistent Bowel Irregularities

 

If you have irregular bowel movements, such as diarrhea, constipation, or alternating between the two, you might have an undiagnosed medical condition. Moreover, blood in the stool, persistent bloating, or weight loss are concerning signs that need medical attention. You might have diarrhea due to food poisoning, celiac disease, or inflammatory bowel disease. Therefore, a stomach doctor must examine you to identify the underlying cause.

 

Regular Heartburn

 

Heartburn causes a sharp, burning sensation in the chest and throat, which worsens after consuming fatty foods or lying down. Regular heartburn is a sign of acid reflux disease, a condition whereby the esophageal lining's acid damages over time. Long-term untreated heartburn can lead to a more severe health condition, like Barrett's esophagus or esophageal cancer. It is crucial to have an endoscopy to diagnose and treat any medical problem.

 

Unexplained Weight Loss

 

Sudden weight loss without excessive restrictions, dieting, or effort indicates an underlying gastrointestinal condition. Weight loss without an apparent cause may indicate an intestinal issue like Crohn's disease, gluten intolerance, or celiac disease. Therefore, it's advisable to see a gastrointestinal doctor to investigate the cause.

 

In conclusion, ignoring stomach issues can negatively impact your life. Therefore, if you notice any of the four symptoms, it's best to see a stomach doctor for diagnosis and treatment. The skill and experience of a stomach doctor can uncover the root of your stomach problems and recommend adequate treatment or medication. Consulting with a stomach doctor will enable you to address these issues, lead a pain-free life, and allow your body to absorb the necessary nutrients for optimal performance.

 

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

Advances in Non-Viral Vector Delivery Systems for Nucleic Acid Drugs

                                                                                                    Image: by Roland1952, CC BY-SA 3.0

Nucleic acid drugs are mainly divided into two major categories: small nucleic acid drugs and mRNA. Small nucleic acid drugs, also known as oligonucleotide drugs, include antisense nucleotides (ASO), small interfering RNA (siRNA), microRNA, nucleic acid aptamers, and others. mRNA products can be further categorized into mRNA vaccines and mRNA drugs.

 

By Carrie Taylor, Director of Business Development of BOCSCI 

 

Characteristics of Nucleic Acid Drugs

 

Nucleic acid drugs offer distinct advantages. Traditional small molecule and antibody drugs primarily function by binding to target proteins, but their development is often constrained by the druggability of these target proteins. In contrast, nucleic acid drugs modulate genes associated with protein expression, enabling them to regulate both intracellular and extracellular proteins, as well as membrane-bound proteins. Moreover, most nucleic acid drugs operate on the principle of base-pairing complementarity, making sequence design relatively straightforward once the target gene’s base sequence is known.

 

However, limitations such as instability, immunogenicity, low cellular uptake efficiency, and difficulties in escaping endocytic pathways have restricted the development of nucleic acid drugs. To address the challenges associated with the molecules themselves, the development of delivery carrier systems that facilitate the uptake of nucleic acids into target cells has become crucial. These delivery carriers need to overcome barriers both extracellularly and intracellularly, withstand nucleases in the bloodstream, enhance and assist in cellular uptake of nucleic acid drugs, and promote intracellular escape of the nucleic acid drugs once inside the cell.

 

Nucleic Acid Drug Delivery System

 

In the early stages of research, viruses were commonly used as carriers for delivering nucleic acids. Virus carriers utilized in clinical trials included adenovirus (Ad), adeno-associated virus (AAV), lentivirus (LV), herpes simplex virus (HSV), and others. However, some virus carriers exhibited undesirable characteristics, such as potential carcinogenicity and high immunogenicity, which led to serious clinical adverse events and hindered the research on their clinical applications. With the development of materials and preparation techniques, non-viral carriers that are cost-effective, easily synthesized, purified, and possess high transfection efficiency with low immunogenicity have emerged as the “optimal candidates” for delivering nucleic acid drugs.

 

1. GalNac  Modification

 

GalNac (N-acetylgalactosamine) conjugate modification is the most commonly used nucleic acid drug delivery system today. GalNac is a lactose analog covalently attached to the 3′ end of nucleic acids in a trivalent form.

 

Following subcutaneous injection of GalNac-siRNA conjugates, they can rapidly enter the liver through the circulatory system. Subsequently, they are rapidly internalized by liver cells through ASPGR receptor-mediated uptake, accumulate in lysosomes, and are slowly released, continuously loading onto the RNA

 

Currently, drugs modified with GalNAc primarily include GalNAc-antisense oligonucleotides (ASO) and GalNAc-siRNA. Since effective ASOs for therapy have already undergone extensive modifications, a delivery carrier is not necessary. siRNAs, on the other hand, are prone to degradation on their own, so carrier delivery technologies are often employed.

 

2. Nanoparticles

 

(1) Lipid Nanoparticle

 

Lipid Nanoparticle (LNP), is one of the important technologies in lipid carrier drug delivery system. The main components are categorized into the following four types:

 

 

1. Ionic lipids that can be ionized are the most crucial excipients and serve as determinants of delivery and transfection efficiency. Due to their relatively easy uptake by antigen-presenting cells, they are commonly used in vaccines.
2. Neutral helper lipids, typically saturated lipids, can increase the phase transition temperature of cationic liposomes, support the formation of a lamellar lipid bilayer structure, and stabilize its structural arrangement.
3. Cholesterol, possessing strong membrane fusion capabilities, facilitates intracellular uptake and cytoplasmic entry of mRNA.
4. PEGylated lipids, located on the surface of lipid nanoparticles, enhance their hydrophilicity, prevent rapid clearance by the immune system, prevent particle aggregation, and increase stability.

 

(2) Polymer Nanoparticles

 

Cationic polymers have become another major type of non-viral gene delivery vector due to their ease of synthesis and flexibility. Polymers can bind with nucleic acids to form polycomplexes at physiological pH, facilitating gene delivery. Typically, polymer nanoparticles contain positively charged units that promote electrostatic binding with nucleic acids. Additionally, covalent linkage between nucleic acids and polymers can be achieved using degradable linkers. Common polymer materials include polyethylenimine (PEI) and chitosan (CS).

 

Another class of polymers used for RNA delivery is dendrimers. These large molecules have a core molecule at their center and are synthesized through repeated growth reactions, resulting in highly branched polymers. Dendrimers carrying cationic groups can form complexes with RNA. Research has shown that they can deliver RNA to the central nervous system and siRNA to liver endothelial cells. Modifying the structure of dendrimers can protect nucleotides from enzymatic degradation.

 

siG12D-LODER is a biodegradable polymer matrix containing siRNA targeting KRASG12D. Currently, Novartis is conducting Phase II clinical trials for siG12D-LODER to assess its effectiveness in combination with chemotherapy drugs like gemcitabine and paclitaxel in treating locally advanced pancreatic cancer patients.

 

(3) Inorganic Nanoparticles

 

Gold nanoparticles have unique optical properties, ease of synthesis and surface functionalization, and can be selectively and synergistically modified with nucleic acids through covalent or non-covalent affixation. Nucleic acid chains are covalently attached to the gold nanoparticle core (typically 13-15 nm) via thiol groups. This strategy can be used for DNA and siRNA, which can be directly attached to gold cores or polymer-modified gold cores.

 

Spherical nucleic acids (SNA) are composed of nucleic acids arranged on the surface of small spherical gold nanoparticles. The platform drug, NU-0129, is currently being studied in a clinical phase 1 study in recurrent glioma. Once NU-0129 crosses the blood-brain barrier and enters the tumor, the nucleic acid component is able to target a gene called Bcl2L12. The researchers believe that targeting the Bcl2L12 gene with NU-0129 will help stop the growth of gliomas.

 

Silica nanoparticles (100-250 nm in diameter), are used for nucleic acid delivery due to their good biocompatibility and tunability. Typically, nucleic acid molecules are loaded into silica nanoparticles through weak non-covalent interactions. Small pore (2.5-5 nm) silica nanoparticles are suitable for delivery of small siRNA.

 

Iron oxide nanoparticles (consisting of Fe3O4 or Fe2O3) have superparamagnetic properties of a certain size and show success as delivery carriers and magnetothermal based therapies. Cationic iron oxide nanoparticles and anionic nucleic acid drugs, bind to each other by electrostatic forces. 50-100 nm lipid-coated iron oxide nanoparticles show optimal siRNA delivery activity.

 

3. New Delivery Systems

(1) Exosomes

 

Extracellular vesicles, derived from endosomes and released into the extracellular space through multivesicular body fusion with the cell membrane, are membrane-bound vesicular structures with diameters ranging between 50 and 150 nm. These extracellular vesicles contain various biological macromolecules, including proteins, nucleic acids, and lipids. Extracellular vesicles can transfer a variety of biological macromolecules between cells, making them a drug delivery method with significant inherent advantages.

 

1. Firstly, extracellular vesicles are “naturally tamed” nanocarriers that inherently contain multiple active components, allowing them to carry a wide range of drug types, including small molecules, nucleic acids, and recombinant proteins.
2. Secondly, as endogenous nanoparticles, extracellular vesicles have low immunogenicity, resulting in high safety.
3. Thirdly, extracellular vesicles can circulate through all the body’s cavities, exhibiting good tissue selectivity.
4. Finally, complex engineering modifications can be applied to extracellular vesicles through genetic or chemical approaches, allowing precise control over their composition and biological functions, thus better serving our therapeutic purposes.

 

(2) Peptides

The current technologies used in nucleic acid drug delivery that are on the market today do not effectively address the issue of tissue-specific targeting. Peptides offer solutions to many problems that other delivery systems cannot resolve. Chemical modifications of non-natural amino acids have greatly improved the half-life of peptide drugs in the body. The development of cyclization techniques has increased the rigidity of peptide structures, significantly enhancing their affinity for target proteins. Peptide-drug conjugates (PDCs) exhibit strong tumor penetration, low immunogenicity, and renal metabolism, among other characteristics.

 

Currently, companies like Ionis, Alnylam, Entrada Therapeutics, and others are actively establishing platforms for peptide-nucleic acid conjugate drugs. The future looks promising for peptide-nucleic acid conjugates.

 

(3) Others

 

Renowned scientist Zhang Feng’s company, Aera Therapeutics, has introduced a novel delivery platform called Protein Nanoparticles (PNP), which utilizes endogenous human proteins to address the limitations of current delivery technologies.

 

Altamira Therapeutics, a biotechnology company focused on RNA therapy, has announced the development of an innovative peptide-based SemaPhoreTM nanoparticle technology platform. This delivery platform is designed for safe and effective systemic or local administration of oligonucleotides such as siRNA and mRNA to target cells. Currently, the company has established two preclinical siRNA projects on this platform for the treatment of KRAS-driven cancers and rheumatoid arthritis.

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

5 Things You'll Need after Tearing Your ACL

An anterior cruciate ligament (ACL) tear is a common injury among athletes, especially those involved in sports that require sudden, pivoting movements like basketball, soccer, and football. According to studies, about 250,000 people experience this injury in the U.S. each year. While it can be a devastating and painful experience, it is treatable with physical therapy, surgery, and the right tools. This blog post is going to explore the five things you'll need after tearing your ACL. These tools will help you heal faster and reduce the risk of re-injury.

 

By Lizzie Weakley

 

Knee Brace

A knee brace is one of the most important tools you'll need to aid recovery after a torn ACL. It provides support to the knee and helps to stabilize it, reducing the risk of further injury. A knee brace also helps to reduce swelling, pain, and discomfort, making it easier for you to move around. There are many types of knee braces out there, from hinged and compression to ROM and post-op braces. Your doctor or physical therapist will recommend the orthopedic rehab equipment that suits your needs.

Crutches

After an ACL injury, your doctor will most likely advise you to stay off your feet and use crutches for a while. Crutches help to keep the weight off your injured knee, reducing pressure and preventing further damage. They also allow you to move around easily and perform daily activities like going to the bathroom or showering. If you're using crutches, make sure to practice proper technique and use them correctly to avoid further injury.

Ice Pack

An ice pack is another essential tool you'll need after tearing your ACL. It helps to reduce swelling, pain, and inflammation, promoting healing and reducing recovery time. Ice packs come in different forms and shapes, from gel packs and ice cubes to ice wraps and bags. Your doctor or physical therapist will recommend the best type for your needs.

Physical Therapy

Physical therapy is an integral part of ACL tear recovery. It helps to restore your knee's range of motion, strength, and flexibility, reducing the risk of re-injury. Physical therapy may include exercises, stretches, massages, and other therapies that target your injured knee. Your physical therapist will create a customized treatment plan based on your needs, goals, and level of fitness.

Positive Attitude

Finally, a positive attitude is crucial when recovering from an ACL tear. It's normal to feel frustrated, sad, and impatient after an injury, but a positive mindset can go a long way in speeding up recovery and

reducing stress. Surround yourself with supportive friends and family, set achievable goals, and celebrate small victories. Remember to be kind to yourself and give yourself time to heal.

Recovering from an ACL tear can be a long and challenging journey, but with the right tools, it's possible to heal faster and reduce the risk of re-injury. A knee brace, crutches, ice pack, physical therapy, and a positive attitude are five things you'll need after tearing your ACL. Remember to consult your doctor or physical therapist before using any of these tools and to follow their instructions to the letter. Keep a positive outlook, believe in yourself, and trust in the healing process. With patience, determination, and the right support, you'll be back on your feet in no time!

 

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

Risk of viral airborne transmission peaks within 5 seconds

 

Scientists have successfully visualized and measured the flow field of aerosol particles derived from exhaled air and examined the risk of viral exposure during face-to-face encounters, such as while walking, jogging, running, or sprinting.

The results, from the University of Tsukuba, showed that the number of aerosol particles during face-to-face encounters peaked within 5 seconds after the encounter and rapidly declined thereafter.

The researchers identified the risk of virus exposure by visualizing and measuring the flow field of aerosol particles derived from exhaled air (jet stream) during face-to-face encounters using a mobile full-scale mannequin and a particle-tracking velocimetry system. Subsequently, the researchers compared the differences between aerodynamic characteristics with and without ventilation and their effects on the risk of virus exposure.

The researchers found that, with or without ventilation, the number of aerosol particles peaked within 5 seconds after face-to-face encounters and then declined rapidly. The higher the transit velocity, the smaller this peak became, which may be due to the increase in the relative velocity between exhaled air and ambient air that facilitated particle diffusion. Furthermore, the number of aerosol particles in ventilated conditions was significantly lower than that in nonventilated conditions.

The results indicate that, to reduce the risk of viral infection during face-to-face encounters, measures such as interrupting inhalation, maintaining a physical distance of at least 1 m, and positioning oneself upwind, are effective within 5 seconds of face-to-face encounters. These findings can help in the management of exposure risk to airborne viruses in general.

 

See: Takeshi Asai, Erina Kurosaki, Kaoru Kimachi, Masao Nakayama, Masaaki Koido, Sungchan Hong. Peak risk of SARS-CoV-2 infection within 5 s of face-to-face encounters: an observational/retrospective study. Scientific Reports, 2023; 13 (1) DOI: 10.1038/s41598-023-44967-x

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