XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each module contains six standard sized containers, which measure 2.6

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Vaccination Vaccine Production Manufacturing 105

XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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Contamination Containment Production Packaging 98

XTalks

AUGUST 10, 2020

The report found that some food packaging, including burger boxes, wrappers, disposable bowls, and bags for french fries, sides and desserts — used at popular restaurants such as McDonald’s, Sweetgreen, and Wendy’s — may contain potentially hazardous PFAS chemicals. McDonald’s Big Mac clamshell container also appeared to be PFAS-treated.

Packaging 98

Packaging Packaging Contamination Containment 98

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

Camargo

NOVEMBER 29, 2021

Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. They are often heat sensitive, membrane impermeable, subject to enzymatic degradation, and susceptible to microbial contamination (a factor which impacts manufacturing steps and quality considerations).

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Development Protein Production Hormones 180

pharmaphorum

JANUARY 30, 2023

Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.

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Contamination Manufacturing Production Containment 52

XTalks

AUGUST 25, 2023

The FDA established the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires that food labels clearly identify the food source names of any ingredients that contain any protein derived from the nine most common food allergens. But how does this differ from government-set standards?

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Allergies Manufacturing Contamination Production 98

Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

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Manufacturing Production Contract Manufacturing Contamination 40

STAT News

NOVEMBER 3, 2022

Plans for a $400 million investment by Eli Lilly in a new manufacturing plant in Limerick, Ireland, have been put on hold following an objection by a local landowner over concerns of flooding of his lands by contaminated water , The Irish Examiner reports. Continue to STAT+ to read the full story…

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Vaccination Vaccine Drug Delivery Systems Sales 97

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

Packaging 98

Packaging Packaging Containment Production 98

pharmaphorum

FEBRUARY 3, 2022

Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches. Uncover principles in best-practice and the benefits of a robust contamination control strategy. Who Should Attend?

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Contamination Scientist Manufacturing Production 52

Pharmaceutical Technology

MAY 11, 2008

In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis. ” LEVEL TRACKING Pharmaceutical manufacturing company Seidenader Vision has also developed a system – the SATrack and Trace. .

Drugs 100

Drugs Packaging Packaging Production 100

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

XTalks

FEBRUARY 5, 2021

Many of the foods purchased by consumers today are contained in packaging made from materials such as paper, plastic, metal or glass. This packaging resists tampering while preserving the physical, chemical and biological properties of the food they contain. Barrier Protection from Oxygen, Water Vapor and Contaminants.

Packaging 64

Packaging Packaging Contamination Containment 64

The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer.

Manufacturing 40

Manufacturing Vaccination Vaccine Production 40

The Pharma Data

DECEMBER 30, 2020

30, 2020 — A hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, according to the U.S. In addition, the recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse is being expanded after manufacturer Sunstar Americas learned of 29 infections. WEDNESDAY, Dec. Shane Erickson Inc.

Contamination 52

Contamination Containment Production Bacteria 52

XTalks

APRIL 11, 2024

Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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Contamination Branding Production Containment 59

pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0

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Compliance Contamination Manufacturing Production 52

Roots Analysis

SEPTEMBER 20, 2023

The focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. It is worth noting that manufacturing process biologics and cell therapies is considerably complex when compared to small molecule drugs. The key steps involved in the supply chain of cell therapy manufacturing are presented below.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

pharmaphorum

JANUARY 24, 2022

The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. Assess engineering containment controls, from isolators and barriers to fully automated lines.

Containment 52

Containment Engineer Contamination Manufacturing 52

FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Containment Contamination Manufacturing Compliance 45

Druggist

OCTOBER 4, 2020

Limit intake of processed food, which contain difficult to digest starch People who experience episodes of diarrhoea should avoid artificial sweeteners, which can cause a laxative effect. Each single dose sachet of granules contains 3.5g Each single dose sachet of granules contains 3.5g £9.12 Buy on Amazon Price incl.

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Containment Pharmacy Bacteria Sales 98

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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FDA Approval Manufacturing Compliance Contamination 72

pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development.

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Contamination In-Vitro Production Containment 52

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. delivery Sale Zovirax Cold Sore Treatment Cream, Tube 2 g Zovirax contains aciclovir, an anti-viral treatment; always read the label Fights the cold sore virus Works at the tingle and blister £6.19 −£1.60 £4.59 What is Zovirax cream?

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Containment Pharmacy Sales Drugs 98

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Manufacturing Production Drugs Contract Manufacturing 59

XTalks

JULY 12, 2023

Despite its prevalent use in the broader food industry, fish bone detection still poses a challenge because fish bones have low density, contain minimal minerals and are incredibly thin, making them difficult to find. Historically, the main reason for installing X-ray equipment was metal contaminant detection.

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Contamination Containment Production Manufacturing 52

The Pharma Data

DECEMBER 30, 2020

Adding to the list of sketchy hand sanitizers and mouthwashes, a hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, CBS News reported Tuesday. Also, the recall of GUM Paroex Chlorhexidine Gluconate Oral Rinse is being expanded after manufacturer Sunstar Americas learned of 29 infections.

Contamination 52

Contamination Vaccination Vaccine Pharmacy 52

Pharma Packaging Solutions

AUGUST 3, 2023

Material All medical device packaging should be manufactured using materials that are both known and traceable. Additionally, the materials used should be non-toxic, odorless, and non-leaching to prevent any possible contamination of the device the packaging is designed to contain.

Packaging 52

Packaging Packaging Pharma Packaging Contamination 52

XTalks

FEBRUARY 20, 2023

The agency will use the proposed levels to determine whether to take enforcement action against baby food companies with products containing lead over that amount. The study also found that the US does not have strict regulations for commercially produced baby foods that are likely to contain toxic metals.

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Manufacturing Regulation Production Containment 52

FDA Law Blog

NOVEMBER 22, 2022

coli contamination. On November 15, as part of the Agency’s implementation of the Food Safety and Modernization Act (FSMA), FDA released the f ood traceability final rule , which aims to reduce the occurrence of foodborne illnesses by enabling FDA to more efficiently identify and remove potentially contaminated food from the market.

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Contamination Production Manufacturing Packaging 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, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

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Drug Delivery Contamination Drugs Production 40

XTalks

AUGUST 7, 2023

Transmission of the molluscum contagiosum virus occurs through direct person-to-person contact or via contaminated objects known as fomites. ’s berdazimer gel, containing 10.3 Immunocompromised individuals are particularly vulnerable to complications and may develop larger lesions. Another noteworthy contender is Novan Inc.’s

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FDA Approval Dermatology Trials Clinical Trials 98

Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. Just as there is not a completely safe and effective drug, there is not an unequivocally foolproof system to make sure every single drug is manufactured at the highest quality.

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Generic Drugs Manufacturing Drugs Regulation 68

Roots Analysis

APRIL 19, 2022

Upstream processing primarily involves the use of single-use bioreactors, sensors, filters, media bags and containers, while in downstream processes, single-use technology is used for chromatography, centrifugation, filtration, sampling system and connectors. [1] 1] The history of bioprocessing technology is mentioned below.

Marketing 52

Marketing Contamination Containment Manufacturing 52

Roots Analysis

JUNE 6, 2024

Autoinjectors Market Manufacturers & Current Landscape Presently, close to 150 autoinjectors have been commercialized / being developed by more than 50 players for the treatment of various therapeutic areas, including diabetes, multiple sclerosis and rheumatoid arthritis.

Medicine 40

Medicine Drug Delivery Manufacturing Marketing 40