pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow.

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Manufacturing Pharma Packaging Production Packaging 98

Pharmaceutical Technology

MAY 11, 2008

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.

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Drugs Packaging Packaging Production 100

XTalks

DECEMBER 1, 2021

Not only can the PD100 ensure produce is safe to eat, but it can also help users develop better fruit and vegetable washing habits over time. The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases.

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Contamination Packaging Packaging Regulation 98

Pharmaceutical Technology

DECEMBER 13, 2022

Secondary drying removes adsorbed residual moisture until the target value is achieved, at which point the material is secured in a moisture-free package. The development of a robust drying system for lyophilisation requires four key components: vacuum pumps, pressure gauges, mass spectrometers, and leak detectors. Detection of leaks.

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Production Contamination Manufacturing Packaging 130

XTalks

NOVEMBER 2, 2021

It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. What are Phthalates?

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Containment Hormones Contamination Packaging 96

Sciensano

APRIL 18, 2023

In order to reduce the amount of packaging waste, the zero-waste trend (bying food in bulk) has recently developed. Sciensano, as a center of excellence in evaluating potential risks of known and emerging contaminants in food contact materials ( FCM ), designed a survey to address this gap. But is this trend safe?

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Containment Packaging Packaging Contamination 52

XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

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Packaging Packaging Containment Production 52

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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Manufacturing Production Contract Manufacturing Contamination 40

Cloudbyz

APRIL 9, 2023

Here are some ways to bring sustainability into clinical trial management: Reduce waste: Clinical trials generate a significant amount of waste, including packaging materials, medical equipment, and biohazardous waste. For example, using reusable containers for shipping materials can reduce the amount of packaging waste.

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Clinical Trials Clinical Trials Trials Biohazard 52

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, they require adequate cleaning and sterilization before reuse, thereby increasing costs.

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Drug Delivery Contamination Drugs Production 40

Pharmacy Checkers

DECEMBER 12, 2019

Perhaps most troubling is that when inspectors’ findings included the most severe designation, called Official Action Indicated, the FDA’s Center for Research and Development (CEDR) downgraded that determination to Voluntary Action Indicated. The GAO plans to follow up on that to find out why. Why do I write “exact same”?

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Drugs Manufacturing Medicine Regulation 71

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. Several drug development trends are driving injectables demand. There are additional risks to consider with parenteral packaging.

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Contamination Packaging Packaging Manufacturing 130

Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. So, we set out to solve some of the problems,” she explains.

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Genome Genomics Medicine Gene Therapy 244

Roots Analysis

FEBRUARY 1, 2024

Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology, and process development. Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products.

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Packaging Packaging Containment Production 40

Pharmaceutical Technology

DECEMBER 8, 2022

Another important example is digital twins, which are enabling the development and installation of new equipment and production processes with less risk and faster timelines. Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies.

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Manufacturing Packaging Packaging Production 246

Pharmaceutical Technology

JANUARY 12, 2023

– about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded.

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Production Contamination Development Manufacturing 130

XTalks

MAY 3, 2024

Foundation for a Broader Regulatory Framework: This rule covering a specific category of poultry products lays the groundwork for a broader regulatory approach, currently being developed, that treats Salmonella as an adulterant to enhance public health. Other food products can also be contaminated with Salmonella.

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Regulation Production Contamination Packaging 103

XTalks

SEPTEMBER 13, 2022

plastic vacuum-packed packages containing ‘GROUND BEEF 85% LEAN/15% FAT’ with codes ‘EST#46841 L1 22 155’ or ‘EST#46841 L5 22 155’ on the side of the packaging.”. “The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. While most E.

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Bacteria Packaging Packaging Production 98

XTalks

NOVEMBER 4, 2022

The ability to rapidly test and detect these pathogens on food and processing equipment allows for immediate intervention and remediation that can reduce widespread contamination that results in loss of product, foodborne illness and subsequent devastating economic impact to the food producers associated with product recalls.”.

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Contamination Bacteria Production Packaging 97

XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Steam is also employed for sterilizing equipment and preventing contamination during packaging processes. Their solution? Superheated steam. Instances of E.

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Manufacturing Contamination Production Packaging 52

Roots Analysis

SEPTEMBER 29, 2023

Closed System – To ensure that there is no chance of contamination or leakage of liquid nitrogen used for freezing and storage of goods, single-use bags can be fully sealed and vacuum packed. Easy access to material : To prevent contamination during sample withdrawal, functionally closed access systems must be implemented.

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pharmaphorum

JUNE 16, 2021

Chronic diseases are the biggest threat to our global socio-economic development. At the same time, living in environments plagued with construction pollution, industrial fumes, and contaminated water, interferes with a child’s mood stability, behavior, and neurological development.

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Medicine Packaging Packaging Contamination 52

The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. recalled packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. ,

Contamination 52

Contamination Packaging Packaging Production 52

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Trulicity (Dulaglutide) Trulicity sales in 2022: $7.439 billion Company/Developer: Eli Lilly & Co.

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Sales Insulin FDA Approval Drugs 52

Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. What is the purpose of a Design History File (DHF) in medical device development? These standards are designed to mitigate risks, enhance device performance, and protect patient safety.

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Compliance Manufacturing Regulation Marketing 52

Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical companies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. Several companies have been charged with manufacturing different components of J&J’s vaccine.

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Sciensano

MARCH 27, 2024

Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.

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Contamination Bacteria Packaging Packaging 52

The Pharma Data

MAY 13, 2021

FACT: A recent study conducted by the Grocery Manufacturer’s Association states that OVER 80% of packaged foods eaten in the U.S. every day are contaminated with at LEAST ONE TOXIC ingredient. This is especially true for your children as they are still developing their brains, bodies, and endocrine systems.

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Production Containment Genetics Doctors 52

XTalks

JANUARY 28, 2025

It outlines the main touchpoints, including the earliest stages of technical transfer and new product introduction, through formulation development and scalable manufacture, and finally ensuring that these potent products are packaged in a safe environment before global distribution to clinic or market.

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FDA Law Blog

MARCH 30, 2025

Increased Testing for Contaminants : To enhance safety, FDA will increase testing for heavy metals and other contaminants in infant formula, as well as other foods commonly consumed by young children. We will continue to monitor Operation Stork Speeds progress and report on any further developments.

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Contamination Packaging Packaging Development 59

FDA Law Blog

MARCH 9, 2025

This event provides a comprehensive guide to the latest developments affecting articles intended for cleansing, beautifying, promoting attractiveness, or altering the appearance.

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Cosmetics Compliance Contamination Regulation 59

XTalks

NOVEMBER 1, 2024

Meatable also partnered with Sticta Biologicals to develop a genome-scale metabolic model of porcine cells, optimizing nutrients for cell growth with more yield and reduced variability. This oven’s AI-driven features also offer insights into temperature regulation and nutrient preservation.

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The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy.

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Contamination Vaccination Vaccine Pharmacy 52

XTalks

SEPTEMBER 14, 2020

And in truth, the companies the White House picked were pretty savvy as several are current front-runners in the race to develop a vaccine. The company is also in collaboration with Ridgeback Biotherapeutics to develop a novel oral antiviral treatment for COVID-19. Moderna’s COVID-19 Vaccine.

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Vaccination Vaccine Antibody Life Science 92