This document provides an overview of process automation in the pharmaceutical industry. It discusses various pharmaceutical manufacturing processes like granulation, drying, milling, and compression. It also describes different types of pharmaceutical processing equipment used for unit operations like mixing, drying, milling etc. Finally, it discusses process automation and concepts like cleaning-in-place and sterilization-in-place which are important for ensuring sterility in pharmaceutical manufacturing.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Basics of Automation in Solid Dosage Form Production (Formulation & Developem...Vishal Shelke
Basics of Automation in Solid Dosage Form Production by Mr. Vishal Shelke(Formulation & Developement M.Pharm Sem II)
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Formulation & Developement
M.Pharm Sem II
Savitribai Phule Pune University
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Basics of Automation in Solid Dosage Form Production (Formulation & Developem...Vishal Shelke
Basics of Automation in Solid Dosage Form Production by Mr. Vishal Shelke(Formulation & Developement M.Pharm Sem II)
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Formulation & Developement
M.Pharm Sem II
Savitribai Phule Pune University
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
Based on Industrial Training internship report in B pharmacy 4th year.
At Roseate Medicare Pharmaceutical Industry Solan.
From Shanti Niketan college of Pharmacy (Malther ,Ratti ,Mandi ,HP 175008)
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
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
Pharmacy compounding - Importance, Non sterile compounding and Sterile compounding, Regulations of US Pharmacoepia, Compounded Products
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1. F.Y.M.Pharm
(Sem-II)
Presentation on
Title of
“Process Automation in Pharmaceutical Industry”
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
IN THE SUBJECT OF
“Pharmaceutical Manufacturing Technology”
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year-
2020-2021
----------------------------------------------------------------------------------------------------------------------------------
1
Presented By- Guided By
Mr.Nitin Dabhade
(Roll No.01)
Dr. S.P. Ahirrao
(Dept. of PMT)
2. Introduction:-
• “Pharmaceutical Processing is the process of drug
manufacturing and can be broken down into a range of
unit operations such as blending, granulation, milling,
coating, tablet pressing, filling and others.”
• “A process automation or automation system (PAS) is used
to automatically control a process such as chemical, oil
refineries, paper and pulp factories.”
• The PAS often uses a network to interconnect sensors,
controllers, operator terminals and actuators. A PAS is
often based on open standards in contrast to a DCS
(distributed control system), which is traditionally
proprietary.” +++
3. Pharmaceutical Manufacturing Processes:-
• The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes choosen according to
physical and chemical characteristics of active pharmaceutical
ingredients.
1. Dry Granulation
2. Powder Blending
3. High Shear And Wet Granulation
4. Fluid Bed Granulation
5. Hot Melt Extrusion
6. Drying
7. Pharmaceutial Milling
8. Compression Of Powder Granules Into Tablets
9. Tablet Coating Equipment
10. Pharmaceutical Encapsulation
11. Microencapsulation
4. 1. Dry Granulation:-
Compaction of a low density powder to a granule. The
roller compation process consists of a combination of
screw feed, compaction and milling systems.
2. Powder Blending:-
In pharmaceutical industry, a wide range of excipients
may be blended together to create the final blend used
to manufacture the solid dosage form.
The uniqueness of each individual drug formulation
assures that no two blending process can be identical.
5. 3. High Shear And Wet Granulation:-
Commonly used processes for densification, to improve
flowability, content uniformity, or wettability or to improve
dispersing the qualities.
4. Fluid Bed Granulation:-
Top spray, bottom spray(wurster) and rotary(tangential spray)
are commonly used in the food and pharmaceutical
industries.
5. Hot Melt Extrusion:-
Utilised in pharmaceutical processing to enable the delievery
of drugs with poor solubility and bioavailability of a
particular interst is the use of HME to disperse active
pharmaceutical ingredients in a mattrix at the molecular
level, thus forming solid solutions.
6. 6. Drying:-
Understanding and controlling the moisture content of
powders is critical to many pharmaceutical processes.
Fluid bed or laminar flow drying conditions impact both
physical and chemical characteristics of powder and
granules.
7. Pharmaceutial Milling:-
The process of using rotary cutters in pharmaceutical
equipments machinery to remove materials from a
workplace by feeding in at an angle with the axis of the
tool.
7. 8. Compression Of Powder Granules Into Tablets:-
An efficient process for producing a solid dose
medication.
9. Tablet Coating Equipment:-
Options includes batch process coating pan off-press
continous coating at continous processing.
10. Pharmaceutical Encapsulation:-
the containment of a solid or liquid dose of a drug in a
soft shell or hard performed capsule.
11. Microencapsulation:-
The process of reducing the particle sizes of pharmaceutical
products, under very high pressure, shear, turbulance,
acceleration and impact, to make them more stable and
clinically effective. +++
8. Pharmaceutical Processing Equipment:-
• Automation refers to use of machines and
equipments for performing physical and mental
operations in the production process in place of
human being.
• Pharmaceutical automation involves mechanical
process of handling materials, distributing
medications and manufacturing and packaging
formulations in industries.
• Pharmaceutical processing equipments incudes a
wide variety of equipments for specific unit
processes, such as;
10. Advantages:-
1. Higher production rates and increased
productivity
2. Efficient use of materials.
3. Better products quality.
4. Improved safety.
5. Shorter workweeks for labor.
6. Reduced factory lead times.
7. Less variability.
8. Greater control and consistency of product
quality.
11. Disadvantages:-
1. High capital expenditure.
2. Higher level of maintenance.
3. Lower degree of flexibility.
4. Worker displacement(major demerit).
5. Emotional stress condition for workers.
6. Relocations of workers to find other work.
7. Workers become slaves of the machine.
8. Society will become dependant on automation
for its economic well being. +++
12. Pharmaceutical manufacturing of sterile Semi-solids:-
• Semisolid products have been manufactured for many years for
distribution as pharmaceutical drug products, cosmetics and health
supplements.
• The semi solids category of comprised if creams, gels, ointments,
suppositories and other topical dosage forms.
Different types of semisolids are:-
1. Ointments
2. Hydrophillic ointments
3. Water emulsifying ointments
4. Hydrophilic ointment bases
5. Creams
6. Gels
7. Hydrophobic gels
8. Hydrophilic gels
9. Pastes
10. Paultices +++
13. Unit operation for semi solids system:-
1. Mixing of liquids
e.g.Kettle and tank filled with agitator
2. Mixing of solids
e.g.Blade mixture and tumbler
3. Mixing of semi solids
e.g.Blade mixture and tumbler
4. Dispersing
5. Milling and size reduction of slid and semi solids
e.g. End runner mill
Hammer mill
Ball mill
Colloidal mill
Micronizer
+++
14. PARENTERAL DOSAGE FORM:-
• Parenteral dosage forms are sterile pyrogen free
preparations intended for administration by the
injection under or through one or more layers of
skin or mucous membrane.
• There are mainly two types of parenteral dosage
form:
A)Small Volume Parenterals (SVP):-
B)Large volume parenterals (LVP):-
15. A) SMALL VOLUME PARENTERALS(SVP):-
• These are usually ranges from 1 to 30 ml in
volume i.e. Less than 100 ml in volume.
• Mostly given as multiple doses.
• Different types of small volume parenterals are
e.g. Ampoules,
Vials,
Dry powder,
Prefilled syringes.
16. Ampules:-
• Ampules are sealed glass containers with an elongated
make that must be broken of our ampules
• Most of the a levels are weakest around the neck for easy
breaking, these will have a coloured band around neck.
• A 5 micron filter needle must be used when drawing
contents of ampoule into syringe, since glass particle may
have fallen inside ampoule, when top was while was snap
off.
• In addition it is useful to wrap on alcohol wipe or small
piece of gauze around top of the ampoule before breaking
it.
• This provides protection for fingers, if ampoule shutters and
will also reduce possibility of glass splinters become
airborne.
17. Vials:-
• The drugs and other additives are packaged in vials either as
liquids or lyophilized powder.
• Made of glass or plastic and are sealed with rubber stopper.
• A needle is used to add contents to or withdraw contents
from the vial.
• Before withdrawing contents from vial and equal volume of
air is usually injected into the vial to pressurize the vial and
aid-in withdrawing contents.
• Vials may designated for single dose or multi dose use.
• Multi dose vial contents preservatives to inhibit bacterial
contamination once vial has been used.
18. Dry powders:-
• Dry powder formulation are lyophilized or freeze dried
powder must be reconstituted with some suitable
solvents to make a liquid formulation before being
withdrawn from vial.
• Some drugs are not stable in liquid form and so these
drugs put into powder form and reconstituted prior
before use.
Pre-filled syringes:-
• It consists of syringes which are prefilled with drug
solution.
• There are two varieties of prefilled syringes, namely a
cartridge type and another is glass tube type.
• After the use, all pieces are discarded.
+++
19. B) LARGE VOLUME PARENTERAL(LVP):-
• A single dose of injection that is intended for I.V. use and
packed in containers labelled as containing more than 100
ml.
• LVPs are aq. solution usually supplied in volume of at least
100 ml with sizes of 250 ml, 500 ml, 1000 ml and 3000 ml
and 5000 ml commonly.
• The directions usually recommend that large quantities are
administered.
• Many different LVPs are commercially available.Packaged
in glass bottles or in large volume flexible containers.
• May contain greater than 100 ml to greater than 1 litre or 2
litre.
19
20. Examples of LVP:-
• Calcium Solution.
• Sodium Chloride Ringer Sodium Bicarbonate.
• Electrolyte Solution.
• Dextrose (Glucose) And Sugar Solution.
• Amino Acid Peptide And Protein Fractions Solutions.
• Solution Containing Combination Of Above or Sometimes with Vitamin
added.
• Dextran And Plasma Expanders.
• Peritoneal Dialysis(LVP).
• Irrigating Solution.
• Hyperalimentation Solution(TPN) i.e. Total Parenteral Nutrition.
• Cardioplegia Solution.
• IV Admixture.
• Infusion.
• Intermittent Solution.
• Pre-mixed I.V. Admixture.
+++
20
21. Control test for SVPs and LVP:-
1) Liquor test 4) Pyrogen test
2) Sterility test 5) Particulate matter test
3) Clarity test 6) Bacterial endotoxin test
============================================
1)Liquor test:-
• It is done by completely submerging sealed
ampoule in a deeply coloured dye solution.
• Generally 1% methylene blue solution is used.
• The ampoule, if not sealed properly dye solution
must present outside an ampoule will enter into
ampoules and make the solution coloured.
22. 2)Clarity test:-
• The parenteral product evaluated is placed against a
white and black background with concern set in motion
in swirling action.
• It is kept in that motion until any particle becomes
visible or not.
• Care is to be taken to avoid any on the air bubbles.
3)Sterility test:-
• Important to check if product meets requirements of
sterility according to official books or not .
• There are two methods.
1.Direct transfer of the sample to sterile culture media
2.The membrane filtration procedure.
22
23. 4)Pyrogen test:-
• Samples of production batch tested in the rabbits for presence of
the pyrogens.
• There are two stages:-
I) Sham Test:-
• If animals are used for the first time in the pyrogen testing,
then condition the animal for 2-3 days by injecting 1 mg/kg
body weight of pyrogen free solution IV.
• Maintain animals like that for 18 hours in the room maintained
at the temperature of 3° Celsius.
• Record the temperature of animals. In the beginning at least 19
minutes before injection and contamination for 3 hours after
injection.
• Any animal showing variation of 0.6 °Celsius or more must not
be used in the main test.
23
24. II)Main test:-
• Determine control temperature of each rabbit by recording temp not more
than 30 min prior to the injection for test solution.
• Inject into air vein of each rabbit 10 ml of a test solution per kg body weight
completing each injection for 10 min after starting administration of drug.
• Test solution must warmed up to 37°±2°C.Record the temp for 1,2 and 3 hrs
subsequent to injection.
The following requirements should be passed:
1. Individual rise in temp. of 0.6°C with respect to control and some of three
individual rabbits does not exceed 1.4°C, sample passes the test
2. If anything above mentioned requirement rises, continue test with five other
rabbits.
3. Individual rise in temp not more than 0.6 degree Celsius and sum of all eight
does not exceed 3.7°C the sample passes the test.
=============================================================
24
25. Monitoring of pharmaceutical manufacturing technology:-
1.Visual method 3.Filtration method
2.Coulter counter method 4.Light blockage method
==============================================================
1. Visual method:-
Field containers are examined against strong illuminated screen by
holding the neck and rotating it slowly or inverted to give foreign matter
out.
2. Coulter counter method:-
It is used for detection of particles less than 0.1 micrometre in diameter.
3. Filtration method:-
Materials are collected on filters and evaluated under microscope
4. Light blockage test:-
It is the technique used for hydraulic oils.
=================================================
25
26. Cleaning in place(CIP):-
• Cleaning in place is a method of automated cleaning interior surface
of pipes, vessels, equipments, filters and associated fittings without
major disassembly.
• CIP is commonly used for equipment as piping tanks and filters.CIP
employs turbulent flow through piping or sprayballs of large
surfaces.In some cases CIP can also be accomplished with fill, soak
and agitate.
• The benefit to industries is that cleaning done is very faster, labour
intensive and more repeatable and posses less chemical exposure
risk.
• CIP started as manual practice working, involving a balance
tank,centrifugal pump and connection to the system being cleaned.
• Since 1950, CIP has involved to include fully automated system with
programmable logic controllers, multiple balance tanks, sensors
valves, and heat exchangers also data acquisition and specially
designated spray nozzle system.
• Simple and manually operated CIP system still found in use today.
26
27. Sterilization in place (SIP):-
• Sterilization in place refers to sterilization of production equipment without
prior disassembly.
• Sterilization is usually carried out by means of superheated system
• SIP system where used in areas where germ reduction plays a decisive role.
• Examples are han biotechnology or or in food industry.
Process of sterilization in place:-
Sterilization is carried out with steam at 120 degrees celsius and to
bar over a period of about 60 to 70 minutes
The duration where is according to application and system types
Challenges of sterilisation with superheated system:-
Displacement of air present in production plant
Increasing temperature in the entire system to require sterilization
temperature
Avoiding temperature process and condensate formation
27
28. Checklist for handling after sterilization:-
• For the safer handling of system many details
precisely defined
• they help to maintain sterility of Process plant
after the sterilization
• Slight over pressure in system all time prevents
imgress of air.
• On developing product sterile use, distilled or
sterilizd water as control rising or decrease in
sterilization.
28