This document summarizes research on the stability of functional native starches compared to modified food starches across different applications and storage conditions. Researchers tested starches in fruit filling, retorted cream soup, and frozen beef gravy stored under chilled, ambient, and frozen conditions. The results showed that select functional native starches, particularly rice-based ones, offered comparable stability to traditional modified starches in all applications and storage conditions. The research provides a better understanding of how formulation, processing, starch selection, storage temperature and duration impact stability. It demonstrates that functional native starches can deliver the same or better stability as modified starches while allowing for clean labels.
ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.
Through this Guidance you are able to understand the basics requirements of Table scoring, agencies recommendations and data to be generated on split tablets.
Case study- Implementing fully integrated solutions for the food industryFedegari Group
The canned food sterilization faces a great challenge: to minimize the quality losses while providing an adequate process to achieve the desired degree of sterility. Temperature deviations are costly while representing under or over processed food, waste of energy and low productivity. This paper describes the implementation of a fully integrated solution for the sterilization process in one of the biggest European tuna can manufacturers.
ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.
Through this Guidance you are able to understand the basics requirements of Table scoring, agencies recommendations and data to be generated on split tablets.
Case study- Implementing fully integrated solutions for the food industryFedegari Group
The canned food sterilization faces a great challenge: to minimize the quality losses while providing an adequate process to achieve the desired degree of sterility. Temperature deviations are costly while representing under or over processed food, waste of energy and low productivity. This paper describes the implementation of a fully integrated solution for the sterilization process in one of the biggest European tuna can manufacturers.
Comparison of stability testing requirements of ich with otherJun Brown
Stability plays an important role in the drug development process. Present work aims to compare the stability
testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory
agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and
European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability
testing requirements for new drug substance and drug product. WHO guidelines describe stability testing
requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information
to be submitted in original and subsequent applications for marketing authorization of their related Finished
pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters
like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term
storage condition (general case) and accelerated storage conditions (substance/product intended to be stored
in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along
with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and
real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on
stability testing requirements for new active substance and related products. It sets out the stability testing
requirements for existing active substance and related finished product. The minimum time period to be covered
by data at the time of submission during long term storage conditions differs from ICH guidelines.
Anam Aslam Mulla -STABILITY OF PHARMACEUTICAL PACKAGES.ANAMMULLA3
This is the presentation about pharmaceutical packages and their various stability testing's ,climatic cabinets as per ICH, FDA Regulations, Protocols, Objectives,& Purpose.
Comparison of stability testing requirements of ich with otherJun Brown
Stability plays an important role in the drug development process. Present work aims to compare the stability
testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory
agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and
European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability
testing requirements for new drug substance and drug product. WHO guidelines describe stability testing
requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information
to be submitted in original and subsequent applications for marketing authorization of their related Finished
pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters
like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term
storage condition (general case) and accelerated storage conditions (substance/product intended to be stored
in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along
with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and
real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on
stability testing requirements for new active substance and related products. It sets out the stability testing
requirements for existing active substance and related finished product. The minimum time period to be covered
by data at the time of submission during long term storage conditions differs from ICH guidelines.
Anam Aslam Mulla -STABILITY OF PHARMACEUTICAL PACKAGES.ANAMMULLA3
This is the presentation about pharmaceutical packages and their various stability testing's ,climatic cabinets as per ICH, FDA Regulations, Protocols, Objectives,& Purpose.
Have you wondered how someone transitions from a sole contributor to a manager? What if there don’t seem to be any opportunities to advance? How do you get others to recognize your potential? Unless you have some leftover wishes, it doesn’t happen by chance. Or maybe you’ve been thinking about that ‘leap’ but you’re not sure if leading others is for you.
If you’re unsure where to start, then consider this informative presentation and learn from someone who has been where you are. Todd DeLuca will outline his experience of being a lone writer to leading a new Technical Communications department. More specifically, he will list and describe activities and actions that helped him demonstrate his capability to decision makers and stand out as a potential leader (to get the job).
Your path to leadership will follow its own unique course. After viewing this presentation, you’ll have tips and pointers on how to pave your own path plus some advice on what you should do when you reach your destination.
Domain-specific glossary compiled, without the aid of terminology management software, while pursing a M.A. in Interpreting & Translation Studies; pages 28-32 are displayed here, which include the indices and the beginning of the reference section
Technical Delivery - Expanded Role for Technical Communicators, STC New Engla...Todd DeLuca, MTSC
Presentation presented to STC New England chapter in Lowell, Massachusetts (MA) on April 2, 2016. Talks about giving the message of tech comm work directly and not relying on others, including how and what to report (share what you're doing).
Change is happening in Pre-College Mathematics! Pressure is mounting to get students into certification and degree bearing tracks. The GED now demands more conceptual math understanding as well as more algebraic content. How Can Faculty Address These Shifts? After a brief overview of institutional responses, Carren Walker of Collaborative for Ambitious Mathematics presents online resources to support teachers who seek to change both content and pedagogy in their courses, with a focus on active learning and formative assessment and specific examples of tasks and approaches. Watch the Blackboard Collaborate Recording of "Transforming the Classroom through the Standards for Mathematical Practice."
A Primer on Hard Gelatin Capsule ManufacturingVivek Sinha
31/03/2015
Hard gelatin capsule shells are used as soluble containers for incorporation of drugs or nutritional
supplements, usually in the form of powders, pellets or granules in the healthcare industry. They are
commonly intended for oral administration having its advantages over other dosage forms that are
used widely by pharmaceutical companies to develop different medicaments and ensure stability of
the product throughout the shelf life. Since it serves as a major excipient for the manufacture of
pharmaceutical products, the quality attributes of hard capsule shells is very vital for performance
and stability of the final product.
Pharmaceutical products are categorized as high quality and high risk product administered to fight
various types of acute and chronic illnesses where the performance of the product should be
reproducible every time it is administered. The capsule shell consists of two cylindrical parts i.e. the
cap and body; both are open at one extreme. Other extreme of both is hemispherical; the open end
of cap overlaps the open end of body and maintains a closure with a typical lock system. Hence, it is
very important that the product achieves the label claim as set forth and is not contaminated and
readily available to the patients. Benchmarking of developments and manufacturing processes in the
pharmaceutical industry as against other industries led to the concept of Quality by Design or QbD.
Over the past few years, QbD has gained considerable acceptance throughout pharmaceutical
industry and has been successfully applied. The key quality attributes of capsules that determine the
process ability on the high speed filling machine are the dimensional characteristics and weight
variability.
The potential variations of empty hard capsules as an input material and its potential impact on
finished product quality has been studied and high consistency within the specification of the critical
quality parameters is confirmed. Annual product quality review needs to be performed using defined
sampling size against set of verification criteria. The built-in quality approach begins at the
development stage of new product where even factors impacting the performance of hard capsules
i.e. formulation, filling machine type, etc., is given due consideration. The selection of proper raw
material, the process validations and stability studies are to be conducted for suitability. The process
conditions should be maintained along with appropriate in-process quality checks. Final release of
product can be done by QA after product and document review. The data on process capability,
trends of quality parameters, technical specification and the evaluation procedure should be
maintained and submitted based on the current level of quality standards.
Sometimes, while seeing the product label. We may get confusion. Some manufacturers print use by date and others best before date across various food product range.Hope my presentation clear the doubts across the consumers
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law.
This step built upon a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development as well as their regulation, and a longer standing recognition of the need to harmonise.The guidance stated in the ICH harmonized tripartite guideline entitled “Stability Testing of New Drug Substances and Products” (issued by ICH on October 27, 1993) applies in general to biotechnological/biological products.
Review of pharmaceutical product, packaging and ichDeepak Shukla
Review of stability of packaged material like containers and closures.
The whole ppt is regarding the test perform to know the stability of a container which is used for product storage.
It also contain the guidelines of ICH.
Piccola Cucina is regarded as the best restaurant in Brooklyn and as the best Italian restaurant in NYC. We offer authentic Italian cuisine with a Sicilian touch that elevates the entire fine dining experience. We’re the first result when someone searches for where to eat in Brooklyn or the best restaurant near me.
Roti Bank Hyderabad: A Beacon of Hope and NourishmentRoti Bank
One of the top cities of India, Hyderabad is the capital of Telangana and home to some of the biggest companies. But the other aspect of the city is a huge chunk of population that is even deprived of the food and shelter. There are many people in Hyderabad that are not having access to
Key Features of The Italian Restaurants.pdfmenafilo317
Filomena, a renowned Italian restaurant, is renowned for its authentic cuisine, warm environment, and exceptional service. Recognized for its homemade pasta, traditional dishes, and extensive wine selection, we provide a true taste of Italy. Its commitment to quality ingredients and classic recipes has made it a adored dining destination for Italian food enthusiasts.
Ang Chong Yi Navigating Singaporean Flavors: A Journey from Cultural Heritage...Ang Chong Yi
In the heart of Singapore, where tradition meets modernity, He embarks on a culinary adventure that transcends borders. His mission? Ang Chong Yi Exploring the Cultural Heritage and Identity in Singaporean Cuisine. To explore the rich tapestry of flavours that define Singaporean cuisine while embracing innovative plant-based approaches. Join us as we follow his footsteps through bustling markets, hidden hawker stalls, and vibrant street corners.
At Taste Of Middle East, we believe that food is not just about satisfying hunger, it's about experiencing different cultures and traditions. Our restaurant concept is based on selecting famous dishes from Iran, Turkey, Afghanistan, and other Arabic countries to give our customers an authentic taste of the Middle East
1. Novel Clean Label Stability Solutions:
Functional Native Starches
Leaslie Carr
Marketing Manager, Wholesome Springboard, U.S.
Ingredion Incorporated
Bridgewater, New Jersey
2. 2
Novel clean label stability solutions:
functional native starches
Defining stability and industry standards
It takes the concentrated efforts of industry experts to design
and market prepared food products. And the demand for
quick-to-prepare, premium quality foods, with clean label
options, is steadily increasing. According to Mintel’s 2012
North America GPG Trend Predictions report, natural (clean
label) formulations appear at all price points, making them
available to all consumers. Delivering these products on an
industrial scale can be challenging. From processing and
transportation through to storage and preparation, prepared
foods are put through their paces.
Products must withstand numerous physical rigors and
temperature changes to deliver appealing texture, appearance
and taste throughout their specified shelf life. To achieve
success, it’s crucial to choose ingredients that deliver
good stability.
Although traditional stabilizers, such as modified food
starches and gums, provide stability, these ingredients do
not support clean labeling. Industry standards are evolving to
include clean label ingredients, specifically those that can
withstand the harsh rigors of modern food processing and
offer equivalent shelf life stability to the modified standards.
Introduced more than a decade ago, functional native
starches are a well-established solution for clean label formu-
lations. Functional native starch ingredients are different from
traditional native starches, such as corn or tapioca starch.
Through proprietary processing, they possess the functional-
ity of modified starches, but can be labeled simply as ‘corn
starch’ — a trusted ingredient.
To better understand how functional native starches perform
in terms of stability, a recent research project was conducted,
which yielded positive results supporting their numerous
functional benefits.
Stability’s impact on product development
An end product’s stability can be affected by a number of
variables along its journey from manufacturer to retail shelf,
including:
• High pasteurization temperatures
• Physical rigors, such as intensive shear during processing
• Temperature fluctuations
• Repeated freeze/thaw cycles
The research objective accounted for this complexity. The aim
of the project was to gain the most comprehensive understand-
ing yet of functional native starch’s stability across different
applications and storage conditions. Through this knowledge,
manufacturers will be able to achieve stability in clean label
products, by selecting the appropriate functional native starch.
Research methodology
The first step in the methodology was to identify appropriate
applications for testing. The research team selected three
applications with different storage requirements — chilled,
ambient, and frozen. The formulations selected differed as
well in pH, ingredients used, and processing. These were:
• Fruit filling (yogurt fruit preparation)
• Retorted cream soup (shelf stable, can/jarred)
• Frozen beef gravy (sauce for frozen ready meal)
A range of starches were selected and used depending on
the formulation, process and storage requirements. Up to ten
starches were evaluated depending on the application. Four
modified starches, the industry benchmarks for stability, were
compared to select functional native starches. The samples
were then tested in the different applications for freeze/thaw,
refrigerated and ambient stability as appropriate, using the
methods outlined below.
Testing methods
Freeze/thaw stability
• Samples placed in freezer at 20°F (-7°C) until frozen
• Samples removed from freezer and thawed at ambient
temperature
3. 3
• Process repeated for a predetermined number of cycles
(length of test depends on application)
• Evaluated for presence of syneresis, gelling and graininess
evaluated after stirring at each freeze/thaw cycle
Refrigerated stability
• Samples placed in refrigerator at 40°F (4°C)
• Evaluated for presence of syneresis, gelling and graininess
weekly for a predetermined number of weeks (length of
test depends on application)
Ambient stability
• Samples stored at ambient conditions
• Evaluated for presence of syneresis, gelling and graininess
weekly for a predetermined number of weeks (length of
test depends on application)
Expert evaluation
Highly trained panelists evaluated all three applications using
the ‘Cook and Look’ sensory ballot. This method uses a 15
point scale to ensure systematic, statistically significant results
(with 15 being the most negative result possible), with stan-
dard references.
Novel stability solutions
Through this deep analysis, researchers obtained statistical
evidence of each starch’s stability in freeze/thaw, refrigerated
and ambient storage conditions. As a result, the most appro-
priate functional native starch variety can now be more easily
identified to deliver the best possible clean label solution for
optimal stability across all three applications and storage condi-
tions tested.
Further, the study’s findings demonstrate that functional
native starches offer similar stability to modified alternatives
in these three popular applications. Whether foods are refrig-
erated, ambient-stored or frozen, functional native starch can
provide the stability processors need and the clean labels
consumers demand.
Key learnings:
• There are various potential sources for texture
instability, such as over processing, starch choice
for storage conditions and ingredient interaction.
• Select functional native starches offer comparable
stability to traditional modified starches.
• Rice-based functional native starches offer similar sta-
bility when compared to traditional modified starches
in all applications tested.
• A comprehensive line of functional native starches is
available to meet various application needs.
In summary
These results provide a deeper understanding of how clean
label functional native starches perform in different applica-
tions and storage conditions. The research also provided
insights into the different factors that affect stability such as
the type of starch, ingredient interactions, storage tempera-
ture and duration, number of freeze/thaw cycles, ice crystal
formation, and excess shear.
These findings challenge conventional thinking surrounding
textural stability during a products shelf life. The shelf life of
a food (whether it is refrigerated, ambient-stored or frozen)
After 18 weeks of refrigerated storage, functional native starch 3 (FNS3) provides
comparable textural stability to traditional modified food starches (MFS) tested.
MFS3
MFS1
MFS2
FNS3
Figure 1: Refrigerated fruit fillings Figure 2: Overall scores for fruit fillings
MFS1 MFS2 MFS3 FNS1 FNS2 FNS3
Starch
Score
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
0
Refrigerated
Freeze/thaw
Ambient
All samples evaluated using ‘Cook and Look’ sensory ballot. Scores >9 deemed
unacceptable. FNS3 provided comparable stability to all MFS under the three
storage conditions. FNS1 and FNS2 exhibited varied performance depending on
the storage condition.