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