Entry To Inoculation Room

1.     Purpose:-

1.1.      It is established to control each and every step for entrance in the Liquid Injectable Sterile Area.

2.     Scope:-

2.1.      This procedure outlines the methods to be followed by all personnel entering into Sterile Area, when area is in operation.

3.     HSE Statement:-                              

3.1.      Follow the following instructions to perform the subjected job in safe manners.
§  Only trained and knowledgeable persons go in aseptic area.
§  Operate only the specific machines, tools and equipment they have been trained to use.
§  All work is performed in accordance with applicable regulatory requirements.
§  Standard operating procedures are in place for machinery and equipment use.
§  Report any job related injuries or illnesses, questions on health and safety, or any unsafe or unhealthy working conditions to their supervisor.
§  Personal protective equipment necessary to enter the aseptic area.

4.     Responsibilities:-                

Ø  Lab Assistant is responsible to conduct assigned tasks in safe manners and report to Microbiologist in case of any problem.
Ø  Microbiologist is responsible to manage all activities include Assistant training, record keeping, proper use of personal protective equipment & other related tasks.

5.     Materials:-                          
5.1.   Sterile Uniforms (Sky Blue Color Uniforms)
ü   Cotton Suit (Trouser + Shirt)
ü   Parachute Head Mask
ü   Parachute Jump Suit
ü   Parachute Shoe Covers with shoes.

6.     Definition:-                        

6.1.   Aseptic Area
§   An Area which can be clear from microbial & Particle contamination.

7.     Flow Chart:-                      

7.1.   Microbiological Lab

Chapter No.
Process Flow Chart

Perform Proper Gowning Before Enter in Washing Area

After Completion of operation Perform De-Gowning before Exit from Inacolation.

§  Gowning Procedure
§  De-Gowning Procedure
§  Lab.Assistant
§  Microbilogist

8.     Description:-

To meet the appropriate standard of cleanliness of sterile area, followed by the following steps:

8.1.   Sterility Testing Room

8.1.1.      Gowning Procedure

ð  First Change Room
ò     Put off factory shoes & Place in rack.
ò     Remove the factory clothing & Place in S.S cabinet in this room.
ò     Keep your under garments on.
ò     Now open the door of second change room.

ð  Second Change Room
ò    Enter the second change room.
ò    Mope Hand With 70% IPA Disinfectant solution.
ò    Select a pair of gloves, slip in the left hand glove first  and then right hand glove in a same manner and spray 70% Isopropyl alcohol on the gloves.
ò    Dry the gloves properly.
ò     Select one pack of sterilized garments, open the pack and take out the sterilized garments.
ò    Wear the sterile cotton Suite (Shirt & Trouser) properly.
ò    Wear the sterile Jump Suite (Parachute) properly leaving no part of body open.
ò    Wear the Sterile parachute head mask.
ò    Wear the sterile shoe covers with shoes.
ò    Discard the hand gloves in the S.S drum placed in this room.
ò    Spray your hands with antiseptic solution (70% Isopropyl alcohol).
ò    Select a packet of gloves.
ò    Slip on the left hand glove slowly and tuck in the uniform sleeve in it.
ò    Repeat the action with right hand glove.
ò    Spray the glove hands with 70% Isopropyl alcohol.
ò    Wear Goggles after mopping hand with 70% IPA.

ð  Third Change Room
Enter the Third change room & open the next door leading to the Inoculation room.

                        Exit from Inoculation Room.
                                    Enter the third and open the door of second Change room

ð  Second Change Room
ò    Enter the second change room.
ò    Remove the goggles, gloves, shoe covers with shoes.
ò    Pull the door of the first change room.

ð  First Change Room
ò    Enter to the first change & remove all the used uniform (Cotton Suit & Jump Suit), parachute head mask & place in a S.S drum.
ò    Wear your stored factory clothing & shoes to come out of the first change room.

8.2.   Precautions before Entering in the sterile area

8.2.1.      The persons entering sterile areas are responsible for complying with this procedure.
8.2.2.      Ensure that articles to be worn in the sterile area to be cleaned & sterilized.
8.2.3.      The wearing of excessive & heavy makeup (cosmetics etc) & jewelry is prohibited in Sterile Area.
8.2.4.      No one who is physically ill, especially with stomach or respiratory disorder or skin lesions should enter in sterile area.

9.     Record:-

§   NA

10.            Reference:-

§   cGMP Guide Lines

11.            Distribution:-                |

Sr. #
Distributed to
Received (Current)
Returned (Obsolete)
Quality Control Department

Quality Assurance Department 

Quality Management Department

12.            Revision History:-

Date                                        Changes