This document provides an overview of the process for manufacturing hard gelatin capsules. It discusses the key raw materials used, including bovine gelatin and food colors. The manufacturing process involves preparing a gelatin mucilage solution, dipping pin bars in the solution to form capsule shells, drying the shells, cutting and joining them, and performing quality checks. The capsules then undergo printing and packaging, with quality testing of raw materials, in-process materials, and finished products. Specifications are provided for testing various attributes of the hard gelatin capsule shells.
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
This document gives detailed information regarding the processes followed in a Pharma Manufacturing Company.
It also includes graphical representation, for easy understanding.
"Capsula" is derived from the Latin word & Is defined as a solid dosage form in which the medicament contained is enclosed within small shell or container.
"Fruit pulp processing involves extracting the pulp from fruits and transforming it into a usable form for various applications.
The egg processing industry involves various operations that transform raw eggs into various products for commercial use. It plays a crucial role in meeting the demand for various egg products and contributes to their availability year-round.
Tech-knowledge: A Weekly Feast of Food Industry Discoveries, Articles, Insights, and fun facts for Industry Innovators and Professionals."
INDUSTRIAL TRAINING REPORT (B-pharmacy ) Zentiva pharmaceutical industry PrakashKumar721
Location:- GIDC Estate Ankleswar
393002, Dist. Bharuch ,Gujrat India
Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4,700 people and a network of production sites - including flagship sites in Prague, Bucharest and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better supportpeople’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators and governments to provide the everyday solutions that we all depend on.
About Zentiva’s Ankleshwar site
Established in 1987, the Ankleshwar manufacturing site has a chemistry and biotechnology development center, and manufactures both intermediates and pharmaceutical formulations. A large producer of tablets, the Ankleshwar site manufactures more than 6 billion tablets annually.
Mission &Values:-
Zentiva is a leading developer and supplier of high-quality affordable prescription medicines and consumer brands. As Zentiva grows more people get the medicine they need. Our business is built on trust and responsibility with the patient at the heart of everything we do. Zentiva has established 6 shared SuperpowerZ which frame the values and behaviours we expect of our team and how we will build a healthy business that we can all be proud of.
TABLET-SECTION
Tablet:-
A tablet is a mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners or flavors to mask the taste of bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A coating may be applied to hide the taste of the tablet's components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life.
Advantage
• Production aspect
Large scale production at lowest cost
Easiest and cheapest to package and ship
High stability
• User aspect (doctor, pharmacist, patient)
Easy to handling.
Lightest and most compact.
Greatest dose precision & least content variability.
Coating can mark unpleasant tastes & improve pt. acceptability.
PHARMACEUTICAL PRODUCT BY ZENTIVA PHARMACEUTICAL PVT.LTD:-
1. Avil -25 mg
2. Trental-400
3. Paracetamol-500mg
4. Ramilich-( 5, 25mg)
5. Ramipril-25mg
6. Zuglimate-500mg
7. Clopidogrel-75mg
8. Metformin-100mg
QUALITY CONTROL AND QUALITY ASSUARANCE
Quality control is the part of GMP that deals with sampling, specification, and testing, as well as organisation, documentation, and release procedures to ensure that necessary and
Waste Minimization and Energy Conservation in Gelatin Production by Raw Mater...ijsrd.com
Based on current manufacturing system of gelatin production, cleaner production opportunities are discussed considering aspect such as waste minimization, energy conservation, etc. Improving the utilization of inputs and minimizing the production of unwanted or low value outputs is fundamental to improving profitability. Adopting cleaner production also helps in awareness of consequences of environmental practices that are unfriendly and that are detrimental to the industry's bottom-line. Adopting cleaner production may require onetime investment or it can be done with zero cost. A few process changes and good housekeeping in production of gelatin may increase gelatin yield and reduces wastewater quantity. Process changes such as automatic handling of machines, direct packaging etc leads to environmental as well as financial benefits. Byproduct utilization and wastewater reuse are other benefits of cleaner production. This paper discuss about current process followed in gelatinization, suggestion of cleaner production opportunities throughout the process and cost benefit analysis for suggested cleaner production opportunities. Major advantages from cleaner production in gelatinization here is byproduct reuse and waste water reutilization.
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
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.
When one form of food is transformed to another form of food involving industrial method to
make it convenience food, that process is known as food Processing. Depending upon the
complexity of industrial method, processing is categorised into primary, secondary, and tertiary
processed food. Fruits and vegetables are perishable in nature having shelf life less than a week
if kept unrefrigerated condition. Also there are currently high post-harvest loss for fruits and
vegetable due to lack of required storage condition and space constrain, hence it is highly
desirable to process fruits to retain their shelf life and also to reduce the size of product which
in turn reduces the cost on transportation of bulk fruit and storage area requirement.
One such product of fruit processing is fruit pulp. Fruit pulp solid mass obtained by extraction
or pressing fruits or vegetables. Pulp is categorised basis their storage condition, i.e., in powder
or liquid form. In liquid form they can be used as either brine, syrup, or water form. Due to food
preference of customer, frozen pulp is also in great demand as all inbuild nutrition are retained.
Le nuove frontiere dell'AI nell'RPA con UiPath Autopilot™UiPathCommunity
In questo evento online gratuito, organizzato dalla Community Italiana di UiPath, potrai esplorare le nuove funzionalità di Autopilot, il tool che integra l'Intelligenza Artificiale nei processi di sviluppo e utilizzo delle Automazioni.
📕 Vedremo insieme alcuni esempi dell'utilizzo di Autopilot in diversi tool della Suite UiPath:
Autopilot per Studio Web
Autopilot per Studio
Autopilot per Apps
Clipboard AI
GenAI applicata alla Document Understanding
👨🏫👨💻 Speakers:
Stefano Negro, UiPath MVPx3, RPA Tech Lead @ BSP Consultant
Flavio Martinelli, UiPath MVP 2023, Technical Account Manager @UiPath
Andrei Tasca, RPA Solutions Team Lead @NTT Data
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties – USA
Expansion of bot farms – how, where, and why
In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks – Europe
Systemic attacks in the Middle East
Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
A tale of scale & speed: How the US Navy is enabling software delivery from l...sonjaschweigert1
Rapid and secure feature delivery is a goal across every application team and every branch of the DoD. The Navy’s DevSecOps platform, Party Barge, has achieved:
- Reduction in onboarding time from 5 weeks to 1 day
- Improved developer experience and productivity through actionable findings and reduction of false positives
- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
Development teams can ship efficiently and ensure applications are cyber ready for Navy Authorizing Officials (AOs). In this webinar, Sigma Defense and Anchore will give attendees a look behind the scenes and demo secure pipeline automation and security artifacts that speed up application ATO and time to production.
We will cover:
- How to remove silos in DevSecOps
- How to build efficient development pipeline roles and component templates
- How to deliver security artifacts that matter for ATO’s (SBOMs, vulnerability reports, and policy evidence)
- How to streamline operations with automated policy checks on container images
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
Generative AI Deep Dive: Advancing from Proof of Concept to ProductionAggregage
Join Maher Hanafi, VP of Engineering at Betterworks, in this new session where he'll share a practical framework to transform Gen AI prototypes into impactful products! He'll delve into the complexities of data collection and management, model selection and optimization, and ensuring security, scalability, and responsible use.
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
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Introduction
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.
Manufacturing of Hard Gelatin Capsule Shells
Raw Materials
The manufacture of hard gelatin capsule shells is by physical molding process where gelatin & water
are the basic raw materials required. Colorants & opacifiers are optional and are used as per
requirement.
Gelatin
Gelatin from bovine source is the main raw material used in the manufacturing of hard capsule
shells. Bovine gelatin used is derived from bones and hides of healthy animals that have been
certified as fit for human consumption by a veterinary official at slaughtering. The tissues used in the
manufacture of gelatin are free from specified risk material. It should be ensured that bovine gelatin
conforms to TSE/BSE regulation as applicable to the country of use. All gelatin used must confirm to
applicable pharmacopoeia and food regulation like:
· Regulation (EC) No 999/2001
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· Regulation (EC) No 853 2004
· Commission directive 2003/63/EC and European Pharmacopoeia - 1483 evidenced by
certificate of suitability.
· USFDA Sept 1997 Guidance to industry for sourcing and processing of gelatin to reduce the
potential risk posed by BSE in FDA regulated product.
· USFDA 21 CFR parts 189, 589, 700 pertaining to prohibited cattle material in human food,
drugs and cosmetics and animal feeds.
· USFDA 9 CFR part 94.18 pertaining to restriction on important edible products from
ruminants due to BSE.
· USFDA 9 CFR part 94.19 on gelatin from ruminants that have not been in any region where
BSE exists
Food Colors
Food colorants applicable to the regulatory standards must be used for the manufacturing of hard
gelatin capsules. Colors that require FDA approval as per customer intent bear the FDA lot number.
Colors not requiring FDA approval, as per local regulation or customer, should be accompanied by
certificate of analysis complying with applicable standard. Stock solutions of food colors are
prepared and the concentration of solution is checked by QC, and suggested for any corrections
required. As per the recipe, known concentration of color stock solutions are added to mucilage to
achieve the required shade conforming to the primary master sample.
Purified Water
Purified water conforming to applicable pharmacopoeia is to be used for preparing mucilage for
capsule manufacturing. The pre-treatment of water is carried out with sodium hypochlorite and
flocculating agents. The pre-treated water is filtered through multigrain, sand filters softened and
demineralized. Demineralized (DM) water is monitored for conductivity and pH. DM water plant is
interlocked for regeneration when pH and conductivity is out of limit. UV lamps are installed at
critical points for control of microbial contamination. The DM water is pumped through 0.2 µ filters.
The distribution and storage is non-corrosive stainless steel. The purified water is maintained at
temperature of 82+ 2 degrees and is under continuous hot loop circulation. In addition, raw water is
checked for hardness daily. User points are also sampled and tested for Micro, hardness, pH,
conductivity, potability on a daily and weekly basis.
Material Movement
After receiving the material, it is quarantined bearing appropriate sticker and the lot information.
Containers are sampled as per the sampling plan by QC under reverse laminar air flow one at a time
and labeled. The sampled material is tested for compliance to the defined pharmacopoeial and in
house specifications. The approved materials are identified by appropriate approved labeling which
mentions the analytical report number and the reassessment date. Storage of quarantine and
approved material is segregated. Only raw materials, which are approved by QC and within the shelf
life, are dispensed and issued to production. The dispensing is carried out based on system
generated recipe for the particular batch; this is done on suitable calibrated weighing scale. Product
is identified by labels, identification cards, and tags at all stages of production.
Raw materials that do not confirm to specifications are labeled with rejected label and stored
segregated in secured manner to prevent inadvertent use till material is returned back to the
vendor. All stages of bulk manufacturing area are designated for in-process rejects and are kept
under control.
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PROCESS CONTROLS
Figure-1 - Schematic of Raw Material Movement Prior to Dipping
Bulk Manufacturing
Mucilage Preparation
The mucilage is prepared in stainless steel jacketed vessels with impeller for uniform mixing of the
additives in controlled environment conditions. The clear transparent gelatin solution is withdrawn
in feed tanks that are also stainless steel jacketed vessel. Each color shade can be identified by
unique identification number and the recipe is stored in the system. The colorants are added as per
the recipe in the feed tank and the final shade is approved by QA. The temperature of gelatin
solution is maintained at 50 +1 degree throughout the process. The gelatin solution should be
converted within 18 hours to ensure there is no risk of microbial growth in the solution. Adequate
in-process checks are done to ensure right quality of mucilage is issued for manufacturing.
Equipment surfaces that come in contact with in-process material/finished product, should be non-
reactive, non-corrosive and non-additive. The pin bars have typical lock pattern and vents engraved
on them for proper locking and to facilitate displacement of air at the time of closing on high-speed
filling machines. The cap of capsule also has pre-locks to reduce possibility of premature separation
of cap and body during transportation and conveying prior to filling. The hard gelatin capsule
machine comprises four main sections:
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Dipping Section
The dip baths hold the gelatin solution for molding. The design of the dip bath is developed to
ensure proper weight spread. The dip bath’s central and parellal functions are monitored to ensure
equal picking up of gelatin at all the four corners of the dipping section. The pin bars undergo one-
and-a-half rotation to ensure uniform distribution of gelatin solution in the dome portion. The pin
bars are reconditioned and polished before re-dipping in the gelatin solution.
Drying Section
The dipped pin bars form stacks and are carried on conveyor to drying section. There are different
drying hoods in the drying section. The temperature and relative humidity in each drying zone is
controlled by maintaining the dew point for proper drying of capsule.
Auto Head Section
The dried shells are carried on a conveyor into the auto head section. The dried capsules are
stripped, cut and joined in this section. The cap and body are held separately in the collet ring and
are cut with specially-designed ceramic blades to the required length. The frequency of blade
checking and replacement is defined and closely monitored.
Air Transfer System
The capsules manufactured are transferred to moisture stabilization chamber through venturi. The
capsules are flushed with controlled air for stabilization of moisture. The capsules, after joining, are
ejected on series of mechanical sorter where defects generated as a virtue of process are trapped
and prevented from further processing. Sorters such as:
Diametrical Sorter: The diametrical sorter is a go-no-go sieve with openings of the size of cap
diameter, allowing any damaged or disfigured capsules are trapped.
Nail Bed Sorter: Usually, the ring created after the cap and body are cut is sucked through vacuum.
However, if not trapped by vacuum, these rings can be trapped in the bed of nails installed. The nail
bed sorter also catches any loose caps or bodies.
Loose Body Sorter: This sorter consists of a rotating disc with spacers between two discs, exactly the
size more than the outer diameter of body and slightly less than the inner diameter of cap. Due to
the rotational movement, only good capsules get carried over to the hopper of venturi. All loose
bodies are collected in rejection tray.
All the above sorters are placed in series at the ejection chute to confirm the defective capsules are
trapped before further processing. The entire manufacturing is auto process and there is no manual
intervention for any intermediate processing.
After moisture stabilization in the chamber, the capsules are again passed through the loose cap /
double cap sorter, diametrical sorter and loose body sorter. In addition, all capsules are passed
through metal detector before collection in shipper boxes; ensuring 100% quality check
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Figure-2 - Schematic for Manufacturing Process Flow
In Process Quality Assurance (IPQA)
IPQA checks for compliance include:
· Colour shade and opacity
· Pre-lock length
· Moisture percentage.
· Pull test
· Brittleness
· Powder stickiness test for clear transparent capsules
· Dimensional parameters after every 4 hours
Assessment of Visual Defects
All the boxes are sampled and checked for visual defects and categorized based on severity of defect
for capsule as a dosage form. Based on defects observed in the sample, all the boxes are graded by
in-process QC inspectors.
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Table-1 - Classification & Types of Manufacturing Defects
Categorization
of defects
Lot Size 500,000 and above
Sample size Acceptance
Number
Rejection
Number
AQL% AOQL%
CAPSULE DEFECTS
Critical 1250 0 1 0.01 0.029
Major 1250 1 2 0.04 0.067
Minor 1250 7 8 0.25 0.360
Table-2 - Indication Acceptable Quality Limits
(The AQLs indicated above could be verified on a composite random sample drawn from √k +1
cartons in the shipment, where k = number of cartons in the shipment.)
Printing and Packing
Imprinting of Capsules
Capsules can be printed in linear or circular form, with or without orientation, and in single, double
& even four-colour printing. Pharmaceutical grade ink is used for printing. The capsules are printed
in the printing head. Ink is applied to engraved printing roller. It is roto-gravure type continuous
printing operation, where the print message with ink is transferred from printing roller to rubber
roller and then onto the capsule.
Printed capsules are online passed through loose body sorter and the diametrical sorters to entrap
any loose body and mashed capsules generated during printing operations. The printing machines
are equipped with electronic camera system to detect foreign capsules in the lot.
Assessment of Printing Defects
Printing defects are evaluated based on sample size and acceptance number derived from the ISO
2859 Part I using single sampling Plan-I. 100% of boxes printed are sampled and checked for printing
defects. Accordingly all boxes are graded by IPQA.
Critical defect Major defect Minor defect
Unprinted Illegible print Multiple print
Broken letter
Smudged print
Off register
Ink spot/ink lines
Light/dark print
Critical defects Major defects Minor defects
Cracked/split
Double dip
Holes
Mashed
Short body
String on end
telescoped
Trims,
Uncut cap/body
Bad join
Closed capsules
Double cap
Grease/oil rings
Long body
Long cap
Loose pieces
Major collet pinch
Major punched dome
Major rough cut
Short cap
Thin spots
Bubbles
Dirt marks
Minor collet Pinch
Minor punched dome
Minor rough cut
Minor splits
Scrapes/scratches
Specks
Star ends
Strings
Wrinkles
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Table-3 - Classification & Types of Printing Defects
Categorization
of defects
Lot Size 500,000 and above
Sample size Acceptance
Number
Rejection
Number
AQL% AOQL%
PRINT DEFECTS
Critical 1250 0 1 0.01 0.029
Major 1250 2 3 0.065 0.110
Minor 1250 21 22 1.0 1.2
Table-4 - Indication Acceptable Quality Limits
(The AQLs indicated could be verified on a composite random sample drawn from √k +1 cartons in
the shipment, where k = number of cartons in the shipment. Corresponding AQL & AOQL values are
also provided therein.)
Figure-3 - Schematic for Printing Process
Quality Control
Testing program is in place that encompasses specifications, sampling plans and test procedures for
raw materials, packaging materials, in-process materials and finished products.
The quality control lab is equipped to perform the testing. This assures the product meets the
required standard in terms of Quality, Purity and Safety.
Preparatory tests are performed to ascertain suitability of microbial tests applied.Once the packing
of product is completed and confirmed in the system, complete document review and product
review is carried out by the QA team and final confirmation for the release of product is done in
system after complete review.
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Table-5 - Specification of Hard Gelatin Capsule Shells as per international capsule manufacturers
TEST SPECIFICATIONS
IDENTIFICATION
Description
Unlocked cylindrical capsules
Colour
Cap As per approved colour shade
Body As per approved colour shade
Print message:
text, colour &
orientation
Cap As per approved artwork
Body As per approved artwork
Identification of gelatin Positive for gelatin
Identification of colorants/iron oxides Conform to approved composition
Identification of Titanium Dioxide Conform to approved composition
PERFORMANCE
Disintegration time in water at 37± 20
C Maximum 15 minutes (with guided disc)
Loss on drying (at 1050
C ± 10
C for minimum
4 hours or to constant weight)
Between 13.0% - 16.0% w/w
Average weight of
capsule shells in mg
(Wt. of 100
capsules/100)
Within
± 7 %
Size 000 00el 00 0xel 0el+ 0el 0
Target 163 130 119 109 108.3 104 96
Range
151.6
-
174.4
120.9
-
139.1
110.7
-
127.3
101.4
-
116.6
100.7
-
115.9
96.7
-
111.3
89.3
-
102.7
Size 1el 1 2el 2 3 4 5
Target 81 76 68.4 63 50 39 28
Range
75.3
-
86.7
70.7
-
81.3
63.6
-
73.2
58.6
-
67.4
46.5
-
53.5
36.3
-
41.7
26.0
-
30.0
PURITY
Odour
No foreign odour after 24 hours when kept at a
temperature between 300
C & 400
C
SAFETY
Sulphated ash Maximum 5 % w/w *
Arsenic Maximum 1 ppm
Lead Maximum 1 ppm
Lubricant content Maximum 0.5 % w/w
Sulphur dioxide Maximum 50 ppm
Mercury Maximum 0.1 ppm
Cadmium Maximum 0.5 ppm
MICROBIAL LIMITS
Total aerobic microbial count Maximum 500 cfu / g
Yeast & mold Maximum 100 cfu / g
Escherichia coli Absent / 1 g
Salmonella Absent / 10 g
Pseudomonas aeruginosa Absent / 1 g
Staphylococcus aureus Absent / 1 g
11. Page | 11
www.acg-associatedcapsules.com
=================================================================================
About ACG Associated Capsules
ACG Associated Capsules (ACG ACPL) is one of the largest manufacturers of two-piece hard gelatin
capsules in the world. To complement its wide range of hard gelatin capsules, ACG ACPL also
manufactures capsules from 100% natural plant source (Naturecaps®
), capsules for filling liquids and
pastes (FlofitTM
), circular two-colour printed capsules (Brandshield®
3600
), four-colour circular-print
anti-counterfeit capsules (Brandshield®
4C), clinical trial capsules (Clinicaps®
) and many more.
Catering to the global pharmaceutical and dietary supplement industries in over 100 countries, ACG
ACPL produces over 60 billion capsules annually through three plants in and around Mumbai, India,
another plant in Ludbreg, Croatia, and a new state-of-the-art facility in Indore, India. Visit www.acg-
associatedcapsules.com for more information.
Why Us?
• Over five decades of experience with hard capsule production
• Versatile product portfolio; capsules made from a variety of raw materials
• Capsules available in a widest range of 14 sizes; from 000 to 5 (including special sizes)
• Up to four-colour linear or circular printing on capsules
• Sophisticated, state-of-the-art manufacturing facilities
• All regulatory approvals, certifications and standards are maintained, which includes US FDA,
EU, Japan, GMP, WHO, ISO, Pharmacopoeia, Kosher and Halal and more
• Warehousing facilities in multiple global locations
• Global sales and service support