This website is written by experts in Pharmaceutical Industry Manufacturing Research and Development and Regulatory Affairs Since 2008 and in 2011 Awarded as one of top 10 websites across world in Pharmaceutical Manufacturing Regulatory
USFDA WHO GMP Guidelines Pharmaceutical Regulations Information about Pharma Quality Managment System Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test

Tuesday, August 11, 2009

TEMPERATURE MONITORING OF DIGITAL TEMPERATURE

TEMPERATURE MONITORING OF DIGITAL TEMPERATURE THERMOSTATIC INCUBATORS BOD INCUBATOR AND THERMOSTATIC INCUBATORS

SOP for monitoring temparaturue of degital thermometer of BOD Incubator and Thermostatic Incubators.

OBJECTIVE :- To establish a procedure for temperature monitoring of Digital

Temperature BOD Incubator and Thermostatic Incubators



UNIT OF RESPONSIBILITY :- QA Executive and Trained QA Assistants



PROCEDURE :-

1) See that the incubators are in ON position

2) Check the temperature to ascertain that it is within the specified limits

3) Check the temperature shown by digital temperature indicator of BOD and

thermostatic incubators

4) The temperature shown by the incubators should not differ by + 05 deg C from the

set temperature

5) Maintain the records of temperatures as per Attachment-I in respective QA,File


TOLERANCE LIMITS : - + 05 deg C

OUT OF LIMITS ACTION :-

If the temperature is not within the specified limits, adjust with the help of adjustment knob


MAINTAINENCE /SERVICING :- To be done as and when required

PERSONNEL TO BE REPORTED TO IN CASE OF NON CONFORMANCE /DEVIATION :

Maintenance Department


FREQUENCY OF OPERATION : Thrice a day

NO OF ATTACHMENT :

RETENTION PERIOD OF RECORDS : Five years

This Website is a Guide for Pharmaceutical Manufacturing Pharmacy Students Pharmacy Colleges and Pharmacists pharmaceutical companies in health care

Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Pharmaceutical companies

Regulatory Affairs in Pharmaceutical Industry

No comments:

Pharma Guidelines Most Read

.

Readers Visit Number

This website is Authentic Source of Pharmaceutical Guidelines

This website is Authentic Source of Pharmaceutical Guidelines

Pharma Validations Quality Management System USFDA Guidelines WHO GMP Guidelines New Drug Update





This website consist of detail Information about Pharma Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test