How Micro-organisms magical process in making of Bread.

Bread

Micro-organisms have been used since ancient times to make bread, cheese, yoghurt and many drinks like  wine etc.All  Food manufacturers continue to use micro-organisms today to make a wide range of food products by a process is known as fermentation. Fermentation not only gives food  but,it  also gives a good taste, texture and smell, but it causes changes that reduce the growth of unwanted food microbes. This improves the food’s storage life and safety. Nowadays fermentations are used to make an amazingly wide range of food and drinks like wine,beer. 

For making of bread yeast plays an major role.Yeast is  called Saccharomyces cerevisiae is mixed with sugar, flour and warm water to make bread. The yeast uses the sugar and the sugars present in the flour as its food. It breaks them down to provide the yeast with energy for growth. The yeast grows by budding. As it does this bubbles of the gas carbon dioxide are produced in the dough.

The bubbles make the dough expand and rise. This is because the dough is extremely sticky and it traps the bubbles, preventing them from escaping. When the dough is baked the heat kills the yeast and the dough stops expanding. 

 

Model Picture of making bread 

 Used to make bread. Yeast is a single-celled fungus. It is able to ferment sugar, producing alcohol and carbon dioxide in the process. It has long been used to make beer and wine as well as bread (the carbon dioxide causes the dough to rise)

Bread 

Effectiveness and Recovery rate of Microorganisms on SCDA plate of Settle Plate in Environmental Monitoring

Environmental Monitoring Programme is essential for evaluation of clean room contamination by known with different techniques are Settle plate , Air Sampling ,Contact plate method. In that Settle plate method is the most important one for determine the contamination levels in clean grades.

Settle Plate Method:

In Environmental Monitoring programme Settle Plate method is also known Passive Air Monitoring . In this method Soya been Casin Digestive Agar(SCDA) 90 mm plates are used for sampling . Passive Air Sampling is performed in clean room grades i.e. A,B,C,D exposure of SCDA Plates for 4 hrs .after exposure SCDA Plates need to incubate at 20- 25 degree centigrade for 72 hrs after incubation Periods SCDA plates transferred into 30-35 degree centigrade for 48 hrs. After incubation period count the number of colonies using by colony counter .

Ex: Location: SPM 16 – 47 cfu /4 hrs

Effectiveness of recovery rate from SCDA Plates in different time intervals:

In this study we need to know the how correlation between the hours of exposure and recovery rate of organisms in clean room monitoring . Initially study was conducted for ten different location in controlled Microbiology laboratory area, SCDA plates( 90mm) expose in particle location in controlled area in different time interwall up to 2 hr, 4 hr, 6hr, and 8 hrs ,after exposure these plates incubated in incubator at 20-25 ⁰c for 72 hrs after transfer SCDA plates into 30-35⁰c for 48 hrs .After incubation count the colonies under colony counter.

Microbiology Laboratory Controlled Area Grade-C Location	02/06/20  Cfu/2 hr	03/06/20  Cfu/4 hr	04/06/20  Cfu/6 hr	04/06/20  Cfu/8hr
PSP01	25	38	29	18
PSP02	26	39	27	19
PSP03	36	42	35	26
PSP04	38	41	34	27
PSP05	18	31	27	21
PSP06	35	42	28	15
PSP07	34	39	29	21
PSP08	28	34	24	11
PSP09	29	31	22	13
PSP10	19	28	21	9
Alert Level	45	45	45	45
Action Level	50	50	50	50

Settle Plate Monitoring Different Time Intervals in Grade-C area of Microbiology Laboratory

Correlation of Recovery rate Colonies Vs Time of Exposure of Settle Plate Monitoring

Summary and Conclusion

From the above data summarises that the number of colonies are gradually decreases from 4 hrs exposure to 8 hr exposure due to over time exposure of SCDA plates leads to dryness and formation of a thick layer on the plate inhibits the growth of colonies and get false positive result. The above conclusion is clearly states that 2 to 4hr time best form environmental monitoring in clean rooms and controlled environment.

Effectiveness of disinfection on Air Sampler Sieve impactor in Environmental monitoring

In Pharmacuetical industry Microbiological Environmental Monitoring programme plays an important role in cleanline grades for evolution of microbial contamination , Sterility of parental drugs and determine the risk.In Environmental monitoring programme Air sampling is one of the best method for know the contamination level of air in aseptic area or cleanline grades.

Air Sampler

Why disinfection is so important in Environmental monitoring

Disinfection is a process to remove microbial contamination on surfaces of equipments

When we use to perform air sampling for different locations in cleanline grades,during interwel of each location we should disinfection on air sampler Seive with IPA 70 percentages by spray and wipe method. Firstly disinfection inside the seive and out side.

70 Percentage IPA

For effectiveness of disinfection in air sampling by select 10 grade C location and 10 grade- A location to perform air sampling first in Grade -C location then transfer to Geade-A location before performing sampling spray the 70 percentage IPA on sterile mop and and wipe inside and out side of seive impactor perform air sampling .For air sampling use SCDA 90mm plate , after sampling incubate Agar plates in 20-25 degrees centigrade for 3 days and 30-35 degrees centigrade for 2 days.after incubation count the colonies under colony counter.

Ex: In Grade-C. – 20 cfu/m3

In Grade A – nil cfu/ m3

Conclusion

If we get nil cfu in grade A is states that disinfection is more effective againist the cross contamination. If not disinfection is not effective.

Data Integrity- ALCOA+

DATA INTEGRITY - ALCOA+ 

          ALCOA is an acronym Wich stands for

A-attributable

L- Legible

C- Contemporeneous

O- Original

A- Accurate

Now ALCOA has expand to ALCOA + Wich consist of Complete, Consistant, Enduring and Available.

•  What is data integrity

FDA guidance on data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends.

Why E-coli is suitable for Endotoxin s extraction

Endotoxins:

Endotoxin is a pyrogenic compound which  increases body temperature like,Fever.

Every gram -ve bacteria produce Endotoxin s when cell has undergone lysis it leads to panic fever.

Why E-coli is suitable for Endotoxin extraction that E-coli contained more Endotoxins campare to other gram -ve bacteria s i.e Pseudomonas, klebsiella,Nisseria, Clostridium etc. In E-coli  more toxic activity of Lipid -A  is associated with polysacharides. 

Cell structure: 

Lipopolysaccharides (LPS), also known as lipoglycans and endotoxins, are large molecules consisting of a lipid and a polysaccharide composed of O-antigen, outer core and inner core joined by a covalent bond; they are found in the outer membrane of Gram-negative bacteria.

Pharmaceutical Microbiology

Introduction

Pharmaceutical Microbiology is a science which deals with microorganisms related clean rooms and drug intermediates finished drugs. Microbiology has great disciplinary in pharma to evaluate the microorganisms in finished goods.

Introduction

Pharmaceutical Microbiology is an applied branch of Microbiology. It involves the study of Microorganisms associated with the manufacture of pharmaceuticals  e.g. minimizing the number of microorganisms in a process environment, excluding microorganisms and microbial biproducts like Exotoxin and Endotoxin from water and other starting materials, and ensuring the finished pharmaceutical product is sterile. Other aspects of pharmaceutical microbiology include the research and development of anti-infective agents the use of microorganisms to detect mutagenic, and carsinogenic activity in prospective drugs, and the use of microorganisms in the manufacture of pharmaceutical products like insulin and human growth hormones. 

Role of Microbiology in Pharmaceutical Industry:

Microbiology play an important role in pharmaceutical Industry to assure the Quality of the drugs. For assuring the drugs need to perform many microbiological tests i.e.

•   Environmental Monitoring
•  Water Analysis
•  Media Preparation 
• Growth Promotion Test
• Microbial Limit Test
• Bacterial Endotoxin Test
• Sterility Test
• Antimicrobial Efficacy Test
•   Preservative Efficacy Test