This document discusses microbial contamination and cross-contamination in pharmaceutical manufacturing. It defines cross-contamination as the presence of small quantities of other products manufactured in the same premises. The types of contamination are physical, chemical, and biological from sources like personnel, equipment, and environment. Cross-contamination can be minimized through personnel procedures, adequate facilities, closed production systems, cleaning validation, and proper air pressure differentials. Special attention needs to be given to prevent cross-contamination of beta-lactam drugs like penicillin which can cause allergic reactions in sensitive patients. FDA regulations require dedicated areas for their production to prevent sensitization issues. Personnel hygiene and housekeeping are important to control contamination.
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
Contamination Control in Cleanrooms_Dr.A. AmsavelDr. Amsavel A
Basic’s of Contamination
Sources of Contamination
Environment Specification
Elements of Cleanroom Design and Qualification
Definitions
Control of Contaminations
People, Cleaning, Environment & Material
Operation, Monitoring and Control
Documents and Records
Personal Hygiene for pharma industry-Dr. A. AmsavelDr. Amsavel A
Personal hygiene
Source of Contamination and control
GMP Requirement /Guideline
Procedures & Records
Protective Clothing & gowning
Health Examination
Hand wash – How and when
Training & Practice
by Dr. A. Amsavel
دورة مختصرة عن المعمل الميكروبيولوجى ودوره فى شركات ومصانع الادوية
المحتوى :
- Introduction to Microbiology
- Microbiology lab. Overview
- Microbiology Lab. Role
- Pharmaceutical Microbiology
- Microbiological tests for pharmaceuticals
الميكروبيولوجى ببساطة
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
دورة مختصرة عن المعمل الميكروبيولوجى ودوره فى شركات ومصانع الادوية
المحتوى :
- Introduction to Microbiology
- Microbiology lab. Overview
- Microbiology Lab. Role
- Pharmaceutical Microbiology
- Microbiological tests for pharmaceuticals
الميكروبيولوجى ببساطة
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
Phụ lục 3 tiêu chuẩn GMP EU về sản xuất thuốc thú y miễn dịch bao gồm:
1. Hệ thống chất lượng.
2. Nhân sự trong nhà máy thuốc thú y miễn dịch.
3. Nhà xưởng, trang thiết bị nhà máy thuốc thú y miễn dịch.
4. Hệ thống phụ trợ nhà máy thuốc thú y miễn dịch.
5. Công nghệ sản xuất.
6. Hệ thống giám sát, quản lý môi trường sản xuất và quá trình vận hành.
7. Kiểm soát chất lượng thành phẩm đầu ra
MANUFACTURING OF PARENTRALS
1. Formulation and Raw Materials:
Concept: The process begins with the formulation of the parenteral drug, determining its composition and concentration.
Raw Materials: High-quality pharmaceutical-grade raw materials, including active pharmaceutical ingredients (APIs), excipients, and solvents, are selected based on their compatibility and purity.
2. Sterilization of Raw Materials:
Concept: Due to the sterile nature of parenteral products, all raw materials, including the API and excipients, must undergo rigorous sterilization.
Methods: Common sterilization methods include autoclaving, filtration, and aseptic processing to ensure aseptic conditions throughout the manufacturing process.
3. Manufacturing Process:
Preparation: The formulation is prepared, and various components are weighed and measured precisely.
Mixing: The ingredients are mixed under controlled conditions to achieve a homogeneous blend, ensuring uniform distribution of the API and other components.
Filtration: The solution is then filtered to remove any particulate matter and ensure clarity.
Filling: The sterile drug solution is filled into vials, ampoules, or other suitable containers in a controlled environment, maintaining sterility.
4. Sterilization of Final Product:
Terminal Sterilization: The final product, in its container, undergoes terminal sterilization methods like autoclaving or gamma irradiation to eliminate any microbial contamination that may have occurred during the manufacturing process.
AMH JOURNALS UK Publishes STERILIZATION OF OPERATING THEATRES by Dr.T.V.Rao MD
Methods to replace fumigation By Dr.T.V.Rao MD is a Professor and Head of the Department of Microbiology at Travancore Medical College in Kollam, India
Dr T V Rao is also a content provider on Medical Microbiology and Infectious Diseases for numerous international websites.
Translated into 91 global languages for benefit many in the remote corners in the Developing countries
Dr.T.V.Rao MD
Microbiological Environmental Monitoring in Pharmaceutical Facilitydelli_intralab
Merupakan jurnal tentang microbiological environment monitoring in pharma facility
Untuk informasi lebih lanjut atau diskusi mengenai environment monitoring, silahkan hubungi delli.intralab@gmail.com
Fundamental Principle Of Dental
I.A.Q.( Indoor Air Quality). Environmental Surfaces Contaminated patient care items and surfaces pose different degrees of risk for infection
transmission based on their location and potential to transmit pathogens. With regards to environmental surfaces, the latest precautionary dental guidelines also provide a better
understanding of how to discriminate between the two categories of environmental surfaces: clinical contact surfaces and housekeeping surfaces.
Control on Cleanroom Environmental Monitoring (Pharmaceutical)Srinath Sasidharan
A general consideration of Environmental Monitoring in Pharmaceutical manufacturing area. Cleanroom Monitoring Tools and Utilities: Author Sreenath Sasidharan (Geltec Healthcare FZE)
India Diagnostic Labs Market: Dynamics, Key Players, and Industry Projections...Kumar Satyam
According to the TechSci Research report titled “India Diagnostic Labs Market Industry Size, Share, Trends, Competition, Opportunity, and Forecast, 2019-2029,” the India Diagnostic Labs Market was valued at USD 16,471.21 million in 2023 and is projected to grow at an impressive compound annual growth rate (CAGR) of 11.55% through 2029. This significant growth can be attributed to various factors, including collaborations and partnerships among leading companies, the expansion of diagnostic chains, and increasing accessibility to diagnostic services across the country. This comprehensive report delves into the market dynamics, recent trends, drivers, competitive landscape, and benefits of the research report, providing a detailed analysis of the India Diagnostic Labs Market.
Collaborations and Partnerships
Collaborations and partnerships among leading companies play a pivotal role in driving the growth of the India Diagnostic Labs Market. These strategic alliances allow companies to merge their expertise, strengthen their market positions, and offer innovative solutions. By combining resources, companies can enhance their research and development capabilities, expand their product portfolios, and improve their distribution networks. These collaborations also facilitate the sharing of technological advancements and best practices, contributing to the overall growth of the market.
Expansion of Diagnostic Chains
The expansion of diagnostic chains is a driving force behind the growing demand for diagnostic lab services. Diagnostic chains often establish multiple laboratories and diagnostic centers in various cities and regions, including urban and rural areas. This expanded network makes diagnostic services more accessible to a larger portion of the population, addressing healthcare disparities and reaching underserved populations. The presence of diagnostic chain facilities in multiple locations within a city or region provides convenience for patients, reducing travel time and effort. A broader network of labs often leads to reduced waiting times for appointments and sample collection, ensuring that patients receive timely and efficient diagnostic services.
Rising Prevalence of Chronic Diseases
The increasing prevalence of chronic diseases is a significant driver for the demand for diagnostic lab services. Chronic conditions such as diabetes, cardiovascular diseases, and cancer require regular monitoring and diagnostic testing for effective management. The rise in chronic diseases necessitates the use of advanced diagnostic tools and technologies, driving the growth of the diagnostic labs market. Additionally, early diagnosis and timely intervention are crucial for managing chronic diseases, further boosting the demand for diagnostic lab services.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
For those battling kidney disease and exploring treatment options, understanding when to consider a kidney transplant is crucial. This guide aims to provide valuable insights into the circumstances under which a kidney transplant at the renowned Hiranandani Hospital may be the most appropriate course of action. By addressing the key indicators and factors involved, we hope to empower patients and their families to make informed decisions about their kidney care journey.
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
Our mission is to provide a safe and supportive environment where our clients can receive the highest quality of care. We are dedicated to assisting our clients in reaching their objectives and improving their overall well-being. We prioritize our clients' needs and individualize treatment plans to ensure they receive tailored care. Our approach is rooted in evidence-based practices proven effective in treating addiction and mental health disorders.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
The Impact of Meeting: How It Can Change Your Life
Microbial Impacts on Pharma Products & Cross Contamination
1. June 2015
& Cross& Cross
ContaminationContamination
Sreenath.SSreenath.S
QC-Micro
WelcomeWelcome
Microbial Impacts on ProductsMicrobial Impacts on Products
2. -He successfully introduced carbolic acid (now
known as phenol) to sterilize surgical
instruments and to clean wounds, which led to a
reduction in post-operative infections and made
surgery safer for patients.
By applying Louis Pasteur's advances
in microbiology, he promoted the idea
of sterile surgery
(pioneer of antiseptic surgery)
"Kills germs that cause bad breath"
3.
Definition of Cross-Contamination
Cross-Contamination is the presence in a particular
product of small, traceable quantities of other
pharmaceutical products manufactured
at the same time in the same premises
previously on the same equipment or in the same
premises
Definition of contamination:
The introduction of impurities of a chemical or
microbiological nature, or of foreign matter, into or onto a
raw material, intermediate, or API (e.g., occurring during
production, sampling, packaging or repackaging, storage or
transport).
4.
Types of contamination:
1.Physical: Ex. Particles/ Fibers /Paint flakes/ Metal parts
2.Chemical: Ex. Moisture/gases/ Molecules/ vapors
3.Biological: Ex. Microorganisms
Examples of Cross-contamination:
1.Physical: Ex. Leakage of oil seal form the reactor
2.Chemical: Ex. If a product exposed to a high RH
environment---- Increase in Moisture content
3.Biological: Ex. Improper Cleaning of equipment/ Use of
unclean equipment for the process
11. • What are contaminants?
• Contaminants are the presence of anything in the
manufactured product which should not be there.
• Contaminants can originate from:
• Environment (particles, micro-organisms, dust
containing other products/materials)
• Equipment (residues of other products, oil, particles,
rust, gaskets, metal) and can be brought into the
product by air movements.
• Personnel
13.
Where Do Contaminants Come From?
• Outside air carries dust which is a contaminant
• People generate contaminants:
We completely shed our outer skin every 24 hrs.
Particles of 0,3 micron & greater are liberated at a
rate varying between of 100 000 to 10 million per
minute
A person walking will liberate 5000 bacteria/minute
and a single sneeze can produce up to 1 million
bacteria.
• The manufacturing process itself can generate
contaminants
• Ex. paint off equipment, dust from belt drives, etc ∆
14. Why All the Concern About Dust?
Typical size relationship between
dust, bacteria and viruses
Virus
(0,006µm to
0,03µm)
Dust Particle
(0,5µm to
500µm)
Bacteria
(0,2µm to
2µm)
Dust Is a Bacteria Carrier
15.
Removal of Dust
• As dust is a carrier, dust must be controlled.
• Ambient bacteria is removed by filtration.
• Internal bacterial distribution can be
controlled by directional air flow and air
flushing or dilution.
• Surface bacteria is controlled by adherence
to strict cleaning sop’s.
16.
Environment
Temp. & RH
Pressure Differential
Air velocity
Air changes
Filter Integrity
Viable & Non-Viable particles
HVAC Controls
17.
Microbial contamination of pharmaceuticals
A pharmaceutical raw material is an active or inactive
substance used in the manufacture of a pharmaceutical
dosage form.
Non-sterile pharmaceutical products with a high degree of
water content may be contaminated with microorganisms.
The contaminating microorganisms may cause spoilage of
the product with loss of its therapeutic properties.
18.
Microbial contamination of pharmaceuticals
Most raw materials for pharmaceutical products support
some forms of microbial growth, depending on the nutritive
properties and moisture contents.
Hence, dry powder or tablets are capable of undergoing
some form of microbial spoilage or degradation. The more
serious problem of microbial contamination of tablets is
where there are no obvious signs of spoilage;
Survival of microorganisms within pharmaceutical products
The survival of microorganism in particular environments is sometimes
influenced by the presence of relatively inert materials. Thus, microbes
can be more resistant to heat or desiccation in the presence of starch,
acacia or gelatin.
21.
• Cross-contamination is a sure indication of bad
practices, as it shows that there is insufficient control
over,
1.Design of premises and systems quality
2.Air handling and dust extraction systems
3.Operation and maintenance of air handling and dust
extraction systems
4.Procedures for cleaning of equipment and for restriction
of movement of personnel
5.Procedures for cleaning of premises
22.
Cross-contamination can be minimized by
1. Personnel procedures (Skilled Manpower, Technical
Awareness)
2. Adequate premises (Proper Lay out, Area
Classification)
3. Use of closed production systems (Man & Material
movement)
4. Adequate, validated cleaning procedures
5. Correct air pressure cascade (HVAC design & Air
Distribution)
25.
Bata-Lactam
Cross contamination
Separation from BP to GP
-penicillin products may cross contaminate other
medicines
-cross-contaminated products can cause severe
anaphylactic reactions and death in sensitive patients
-more than one drug is manufactured in the same
production line. This is the source of cross-
contamination since residuals of former drug may be
passed to the latter drug.
26.
Bata-Lactam
Cross contamination
Separation from BP to GP
-The cGMP requires that production of penicillin and
other preparations liable to be contaminated shall be
carried out in dedicated areas
Penicillin can be a sensitizing agent that triggers a
hypersensitive exaggerated allergic immune response
in some people.
27.
21 CFR 211.42(d), 211.46(d), and 211.176.
Non-penicillin beta-lactam drugs also may be
sensitizing agents. Cross-contamination with non-
penicillin beta-lactam drugs can initiate the same
types of drug-induced hypersensitivity reactions that
penicillins can trigger, including life-threatening
allergic reactions. Therefore, manufacturers of non-
penicillin beta-lactam drugs should employ similar
control strategies to prevent cross-contamination,
thereby reducing the potential for drug-induced, life-
threatening allergic reactions.
Bata-Lactam
Cross contamination
Separation from BP to GP
Dust carries bacteria, much like a dog carries fleas.
Dust can be categorized into 3 groups:
COARSE DUST (50-500 microns) – settles rapidly
FINE DUST (1,0 – 50 microns) – settles slowly
ULTRA FINE DUST (< 0,5 – 1 micron) – remains suspended.