This document discusses aseptic processing and provides an overview of key aspects such as manufacturing environment classification, personnel requirements, preparation and filtration of solutions, filter validation, equipment sterilization, process validation, and additional issues related to isolators, blow-fill-seal technologies, and aseptic bulk processing. The manufacturing environment is classified into grades A through D based on airborne particle levels, with grade A requiring the cleanest conditions for high risk operations like filling. Personnel must be properly trained and attired to prevent contamination. Solutions intended for sterile filtration are prepared in grade C or higher, then filtered through a validated 0.22μm or smaller filter. All equipment and containers must also be sterilized using validated methods
The document outlines good warehousing practices including personal hygiene, physical facility maintenance, storage handling, sanitation, process equipment, housekeeping, and pest control. Key points include washing hands, wearing protective clothing, organizing pallets and safely loading/handling materials, keeping washrooms and floors clean, removing waste, and reporting any pest or microbe growth. Maintaining cleanliness, orderliness, safety procedures and sanitary conditions are essential for good warehousing practices.
This document discusses quality control testing standards and procedures for pharmaceutical packaging materials. It outlines tests for various packaging components like glass containers, plastic packaging, and rubber stoppers. Key tests described include appearance and dimensional checks, compatibility testing, chemical resistance tests like powdered glass tests and water attack tests, sterility validation tests for sterile products, and non-sterile product validation tests. The document emphasizes that quality control testing is important to ensure packaging and components are defect-free and can safely contain drug products.
This document discusses types of closures and closure liners used for containers. It describes five basic closure designs: screw on, crimp on, press on, roll on, and friction fit. It also discusses tamperproof, child resistant, and dispenser applicator variations. Common closure materials are plastic, metal, and laminates. Closure liners are used to create a seal and come in homogeneous one-piece or heterogeneous multi-layer designs. Selection factors for closures and liners include chemical inertness, permeability, stability, and economics. Regulations require packaging materials to preserve drug quality and safety.
GLP (Good Laboratory Practice) is a set of principles established by the FDA in 1978 to ensure the quality and integrity of safety data submitted for regulatory purposes. Key aspects of GLP include standardized facilities, equipment, test systems, operating procedures, personnel responsibilities, and record keeping. Studies must follow detailed study plans and SOPs. Quality assurance programs verify compliance. Proper storage and retention of raw data, samples, and reports is also required under GLP guidelines.
The special measures that need to be considered in the
storage and distribution of product, such that the
products will be of the nature and quality intended
when it reaches the consumer
This document discusses flavor absorption by plastic packaging materials. It finds that polyolefins like LLDPE and PP absorb flavors to a much higher degree than polyesters like PC, PET, and PEN. Absorption is influenced by properties of the polymer like glass transition temperature and crystallinity, as well as properties of the flavor molecule like concentration, polarity, and molecular size. Higher temperatures increase absorption for all materials. Polyesters are preferred over polyolefins for packaging due to their much lower absorption.
This document discusses aseptic processing and provides an overview of key aspects such as manufacturing environment classification, personnel requirements, preparation and filtration of solutions, filter validation, equipment sterilization, process validation, and additional issues related to isolators, blow-fill-seal technologies, and aseptic bulk processing. The manufacturing environment is classified into grades A through D based on airborne particle levels, with grade A requiring the cleanest conditions for high risk operations like filling. Personnel must be properly trained and attired to prevent contamination. Solutions intended for sterile filtration are prepared in grade C or higher, then filtered through a validated 0.22μm or smaller filter. All equipment and containers must also be sterilized using validated methods
The document outlines good warehousing practices including personal hygiene, physical facility maintenance, storage handling, sanitation, process equipment, housekeeping, and pest control. Key points include washing hands, wearing protective clothing, organizing pallets and safely loading/handling materials, keeping washrooms and floors clean, removing waste, and reporting any pest or microbe growth. Maintaining cleanliness, orderliness, safety procedures and sanitary conditions are essential for good warehousing practices.
This document discusses quality control testing standards and procedures for pharmaceutical packaging materials. It outlines tests for various packaging components like glass containers, plastic packaging, and rubber stoppers. Key tests described include appearance and dimensional checks, compatibility testing, chemical resistance tests like powdered glass tests and water attack tests, sterility validation tests for sterile products, and non-sterile product validation tests. The document emphasizes that quality control testing is important to ensure packaging and components are defect-free and can safely contain drug products.
This document discusses types of closures and closure liners used for containers. It describes five basic closure designs: screw on, crimp on, press on, roll on, and friction fit. It also discusses tamperproof, child resistant, and dispenser applicator variations. Common closure materials are plastic, metal, and laminates. Closure liners are used to create a seal and come in homogeneous one-piece or heterogeneous multi-layer designs. Selection factors for closures and liners include chemical inertness, permeability, stability, and economics. Regulations require packaging materials to preserve drug quality and safety.
GLP (Good Laboratory Practice) is a set of principles established by the FDA in 1978 to ensure the quality and integrity of safety data submitted for regulatory purposes. Key aspects of GLP include standardized facilities, equipment, test systems, operating procedures, personnel responsibilities, and record keeping. Studies must follow detailed study plans and SOPs. Quality assurance programs verify compliance. Proper storage and retention of raw data, samples, and reports is also required under GLP guidelines.
The special measures that need to be considered in the
storage and distribution of product, such that the
products will be of the nature and quality intended
when it reaches the consumer
This document discusses flavor absorption by plastic packaging materials. It finds that polyolefins like LLDPE and PP absorb flavors to a much higher degree than polyesters like PC, PET, and PEN. Absorption is influenced by properties of the polymer like glass transition temperature and crystallinity, as well as properties of the flavor molecule like concentration, polarity, and molecular size. Higher temperatures increase absorption for all materials. Polyesters are preferred over polyolefins for packaging due to their much lower absorption.
This document discusses various packaging solutions to prevent pilferage and tampering of pharmaceutical products. It describes common types of pilferproof and tamper-evident packaging such as blister packs, shrink wrapping, pouches, bottle seals, tape seals, and breakable caps. The document also discusses considerations for making packaging pilfer-resistant and tamper-evident, as well as historical examples like the 1982 Chicago Tylenol murders that led to new anti-tampering laws.
Types of dairies and perisable nature of milk.pptSurendra664913
This document discusses key considerations for dairy plant design and layout. The perishable nature of milk means time is the most important factor. Plant layout must account for seasonal capacity fluctuations and prioritize hygiene. Milk reception dock equipment must efficiently handle the volume of milk received via cans or tankers while quickly cooling the milk. Flexible design allows adaptation to changing supply and demand conditions over time.
Bubble wrap was invented in 1957 by two engineers as a textured wallpaper but was later used for packaging. It provides protection for shipping and storing breakable items using less material than alternatives. Bubble wrap comes in various sizes for small and large packaging needs and has benefits like recyclability and stress relief from popping bubbles. The world record for popping bubble wrap was set by 942 people participating.
PROCESSING OF CONTAINERS
A. Glass container
List of inorganic compounds used to impart color in glass
Manufacturing Process of glass
B. Plastics container
Classification of plastics
Manufacturing process of plastic container-
Additives of plastics
B. Metal
2. CLOSURES
Materials used for closures
Types of closures
3. CHILD RESISTANT PACKING
4. TAMPER EVIDENT PACKING
*List of inorganic compounds used to impart color in glass
*Manufacturing process of plastic container-
Injection molding
Extrusion
Composite film manufacturing
Blow molding
Solvent casting
Compression molding
In 1992 FDA approves the following configurations as tamper evident packaging:-
1.Film wrappers 11. Metal/cans
2.Blister package
3.Strip package
4.Bubble pack
5.Shrink seals and bands
6.Foil, paper, plastic pouches
7.Bottle seals
8.Tape seals
9.Breakable caps
10.Aerosol containers
The document discusses the Food Safety and Standards Act (FSSA) 2006 and its impact on the food industry in India. It outlines some key issues with the previous multiplicity of food laws such as varied quality standards. It then summarizes some of the major features of the FSSA including provisions for licensing and registration, enforcement, adjudication, penalties, and regulations developed under the Act. Overall, the FSSA aims to establish a single reference point for all issues related to food safety and standards in India.
The document discusses the structure and objectives of the Food Safety and Standards Authority of India (FSSAI). It was established in 2011 under the Food Safety and Standards Act 2006. FSSAI is administered under the Ministry of Health and Family Welfare and has its headquarters in New Delhi. Its key objectives are to regulate food safety, set science-based standards, and ensure availability of safe food for consumption in India. FSSAI publishes different colored books to promote food safety awareness among various groups.
This document provides an overview of ISO standards including ISO 9001 and ISO 14001. It discusses:
- The history and present scenario of ISO as an independent international standardization body with 162 member countries.
- The benefits of ISO standards in ensuring safety, reliability and quality for businesses and access to new markets.
- An overview of the key requirements of ISO 9001:2008 for quality management systems and ISO 14001 for environmental management systems.
- Updates and changes in ISO 9001:2015 and ISO 14001:2015 including greater emphasis on risk-based thinking and the Plan-Do-Check-Act cycle.
CKAN : 資料開放平台技術介紹 (CAKN : Technical Introduction to Open Data Portal)Jian-Kai Wang
以「技術背景」,「CKAN 架構」,「客製化模版與模組」與「客製化頁面與語言轉換」等四大主軸介紹臺灣疾管署開放資料平台採用之 CKAN 系統架構。
平台 : https://data.cdc.gov.tw
日期 : 2016/09/02
The content consists of (1) background of system operations, (2) the architecture of ckan, (3) customized module and template, (4) customized pages and language translation.
Platform : https://data.cdc.gov.tw
Date : 09/02/2016
This document discusses various packaging solutions to prevent pilferage and tampering of pharmaceutical products. It describes common types of pilferproof and tamper-evident packaging such as blister packs, shrink wrapping, pouches, bottle seals, tape seals, and breakable caps. The document also discusses considerations for making packaging pilfer-resistant and tamper-evident, as well as historical examples like the 1982 Chicago Tylenol murders that led to new anti-tampering laws.
Types of dairies and perisable nature of milk.pptSurendra664913
This document discusses key considerations for dairy plant design and layout. The perishable nature of milk means time is the most important factor. Plant layout must account for seasonal capacity fluctuations and prioritize hygiene. Milk reception dock equipment must efficiently handle the volume of milk received via cans or tankers while quickly cooling the milk. Flexible design allows adaptation to changing supply and demand conditions over time.
Bubble wrap was invented in 1957 by two engineers as a textured wallpaper but was later used for packaging. It provides protection for shipping and storing breakable items using less material than alternatives. Bubble wrap comes in various sizes for small and large packaging needs and has benefits like recyclability and stress relief from popping bubbles. The world record for popping bubble wrap was set by 942 people participating.
PROCESSING OF CONTAINERS
A. Glass container
List of inorganic compounds used to impart color in glass
Manufacturing Process of glass
B. Plastics container
Classification of plastics
Manufacturing process of plastic container-
Additives of plastics
B. Metal
2. CLOSURES
Materials used for closures
Types of closures
3. CHILD RESISTANT PACKING
4. TAMPER EVIDENT PACKING
*List of inorganic compounds used to impart color in glass
*Manufacturing process of plastic container-
Injection molding
Extrusion
Composite film manufacturing
Blow molding
Solvent casting
Compression molding
In 1992 FDA approves the following configurations as tamper evident packaging:-
1.Film wrappers 11. Metal/cans
2.Blister package
3.Strip package
4.Bubble pack
5.Shrink seals and bands
6.Foil, paper, plastic pouches
7.Bottle seals
8.Tape seals
9.Breakable caps
10.Aerosol containers
The document discusses the Food Safety and Standards Act (FSSA) 2006 and its impact on the food industry in India. It outlines some key issues with the previous multiplicity of food laws such as varied quality standards. It then summarizes some of the major features of the FSSA including provisions for licensing and registration, enforcement, adjudication, penalties, and regulations developed under the Act. Overall, the FSSA aims to establish a single reference point for all issues related to food safety and standards in India.
The document discusses the structure and objectives of the Food Safety and Standards Authority of India (FSSAI). It was established in 2011 under the Food Safety and Standards Act 2006. FSSAI is administered under the Ministry of Health and Family Welfare and has its headquarters in New Delhi. Its key objectives are to regulate food safety, set science-based standards, and ensure availability of safe food for consumption in India. FSSAI publishes different colored books to promote food safety awareness among various groups.
This document provides an overview of ISO standards including ISO 9001 and ISO 14001. It discusses:
- The history and present scenario of ISO as an independent international standardization body with 162 member countries.
- The benefits of ISO standards in ensuring safety, reliability and quality for businesses and access to new markets.
- An overview of the key requirements of ISO 9001:2008 for quality management systems and ISO 14001 for environmental management systems.
- Updates and changes in ISO 9001:2015 and ISO 14001:2015 including greater emphasis on risk-based thinking and the Plan-Do-Check-Act cycle.
CKAN : 資料開放平台技術介紹 (CAKN : Technical Introduction to Open Data Portal)Jian-Kai Wang
以「技術背景」,「CKAN 架構」,「客製化模版與模組」與「客製化頁面與語言轉換」等四大主軸介紹臺灣疾管署開放資料平台採用之 CKAN 系統架構。
平台 : https://data.cdc.gov.tw
日期 : 2016/09/02
The content consists of (1) background of system operations, (2) the architecture of ckan, (3) customized module and template, (4) customized pages and language translation.
Platform : https://data.cdc.gov.tw
Date : 09/02/2016
在這個資料科學蔚為風潮的年代,身為一個對新技術充滿好奇的攻城獅,自然會想要擴充自己的武器庫,學習嶄新的資料分析工具;而 R 語言,一個由統計學家專門為了資料探索與分析所開發的腳本語言,具有龐大的開源社群支持以及琳瑯滿目、數以萬計的各式套件,正是當今學習資料科學相關工具的首選。
然而,R 語言的設計邏輯與一般的程式語言不同,工程師們過去學習程式語言的經驗,往往造成學習 R 語言的障礙,本課程將從 R 語言的基礎開始,讓同學們從課堂講解以及互動式上機課程中,得以徹底理解 R 語言的核心概念與精要,學習如何利用 R 語言問資料問題,並且從資料分析的角度撰寫效率良好同時具有高度可讀性的 R 語言代碼。
28. H(M)ASN.101 ?? … 00??00
923f … bc 28
3
=
RSA Signature Forgery in python-rsa ( 2016 )https://blog.filippo.io/bleichenbacher-06-signature-forgery-in-python-rsa/
29. A Decade After Bleichenbacher '06, RSA
Signature Forgery Still Works ( 2019 )
30. A Decade After Bleichenbacher '06, RSA
Signature Forgery Still Works ( 2019 )https://i.blackhat.com/USA-19/Wednesday/us-19-Chau-A-Decade-After-Bleichenbacher-06-RSA-Signature-Forgery-Still-Works.pdf
• 整個格式固定是 n 這麼長
• ⽤用 Symbolic Execution 去找到可以任意亂塞的部分有多長
31. A Decade After Bleichenbacher '06, RSA
Signature Forgery Still Works ( 2019 )https://i.blackhat.com/USA-19/Wednesday/us-19-Chau-A-Decade-After-Bleichenbacher-06-RSA-Signature-Forgery-Still-Works.pdf
• 實作缺陷 : padding bytes 可以是任意字元
H(M)ASN.101 ?? … 00??00
CVE-2018-15836Openswan 2.6.50
32. CVE-2018-16152strongSwan 5.6.3
A Decade After Bleichenbacher '06, RSA
Signature Forgery Still Works ( 2019 )https://i.blackhat.com/USA-19/Wednesday/us-19-Chau-A-Decade-After-Bleichenbacher-06-RSA-Signature-Forgery-Still-Works.pdf
• 實作缺陷 :
• Algorithm Parameter 可以是任意字元
• Algorithm OID 後⾯面可以有多餘的字元
H(M)01 FF … 00FF00 ASN.100
03 20 03 0c Algorithm Parameter 04 10Algorithm OID
33. CVE-2018-16150axTLS 2.1.3
A Decade After Bleichenbacher '06, RSA
Signature Forgery Still Works ( 2019 )https://i.blackhat.com/USA-19/Wednesday/us-19-Chau-A-Decade-After-Bleichenbacher-06-RSA-Signature-Forgery-Still-Works.pdf
• 實作缺陷 :
• 可以有多餘的字元在後⾯面
• Algorithm Identifier 可以是任意字元
H(M)01 FF … 00FF00 ASN.100
03 20 03 0c Algorithm Identifier 04 10
Garbage