SOP for Cleaning of Incubator : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

SOP for Cleaning of Incubator

Standard operating procedure of cleaning of Incubators.

1.0 PURPOSE

To lay down the procedure for operation and cleaning of Incubator.

2.0 SCOPE

It is applicable to the incubator.

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Operation

5.1.1 Connect the unit with electrical mains; switch ‘ON’ the incubator.
5.1.2 The green light glow.
5.1.3 To set the desired temperature use arrow keys. The lower display will display set temperature.
5.1.4 After getting desired set temperature leave the controller for 1 second the set temperature will blink one time and it will be registered in the memory.
5.1.5 The range of the temperature is,
Temperature range Set temperature
55 – 60 °C 57.5 °C
40 – 45 °C 42.5 °C

5.2 Loading and unloading of samples into and from Chamber

5.2.1 Unlock the outer door and locate the place where the sample has to be placed.
5.2.2 Open the inner door and load the samples.
5.2.3 Close the inner door and close the door latch.
5.2.4 Close the outer door.
5.2.5 For unloading follow the same procedure for opening the door, remove the samples and close the door.

5.3 Suggestions To Rectify Problems

5.3.1 If the temperature is going less than the set temperature, check the solid state relay (S.S.R) relay of the heater
5.3.2 If the temperature is not rising, check that safety thermostat is not tripping OFF. If so then set it to higher values. Also, check the proportional integral derivatives (PID) settings.
5.3.3 If the temperature is continuously rising then check if S.S.R is short. If so change the relay immediately.

5.4 Recording of Data

5.4.1 Recording of the temperature shall be done in morning, afternoon and evening.
5.4.2 Record the details of temperature.
5.4.3 Analyst for meeting the acceptance criteria for temperature shall monitor the above date and the section in-charge or his/her designee shall check it.

5.5 Temperature Interruptions

5.5.1 The temperature interruptions for the incubators can be defined as Interruptions, Minor, Major and Critical.
5.5.2 Interruptions: The activities that have very low or no impact on the quality of the material that is if the temperature interruptions are observed for less than 4 hours. This will be considered, as interruptions and a remark for the reason shall be put on the temperature monitoring reports.
5.5.3 Minor: The activities, which have a minor impact on the quality of the material that is if the temperature interruptions are observed between 4 hours and 8 hours. This will be considered as minor interruptions and a remark for the reason shall be put on the temperature monitoring reports after evaluating.
5.5.4 Major: The activities, which have a major impact on the quality of the material that is if the temperature interruptions are observed between 8 hours and 24 hours. This will be considered as major interruptions and a Work Request Memo shall be given to the engineering department for the further action. Also, the impact assessment shall be carried out on the material stored.
5.5.5 Critical: If the temperature interruptions are observed for more than 24 hours, this will be considered as critical. In case of critical interruptions, the Work Request Memo shall be given to the engineering department for the further action. Also, the material shall be transferred to a standby incubator or another incubator running at same temperature conditions.
5.5.6 In case of the incubator with the same conditions is not available, the samples shall be stored at controlled room temperature until the incubator has been restored to its original condition.

5.6 Cleaning of Incubator

5.6.1 The outer surface shall be cleaned daily with damp and but not dripping nylon mop.
5.6.2 Inner walls and shelves shall be wiped with 70% IPA at least once a month and it will be recorded.

5.7 Precautions

5.7.1 Do not block the air passage area with samples.
5.7.2 Do not place anything on the top of the equipment or do not stand on the top of the equipment.
5.7.3 Free space on the side of the trays should not be blocked by the samples.
5.7.4 Air circulation holes in the chamber should not be blocked.
5.7.5 Sensor should not be covered with the samples. Avoid mixing with the previously incubated material.
5.7.6 Do not keep the door of the incubator open for more than 2 minutes at a time.
5.7.7 Do not change the internal parameters of the controller, which might change the calibration.

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 IPA - Isopropyl alcohol
Get ready to use editable documents in MS-Word FormatView List





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


No comments:

Post a Comment

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts