Standard Operating Procedure for Operation and Cleaning of Sampling and Dispensing Glove Box

Standard Operating Procedure for Operation and Cleaning of Sampling and Dispensing Glove Box
Standard Operating Procedure for Operation and Cleaning of Sampling and Dispensing Glove Box

Standard Operating Procedure for Operation and Cleaning of Sampling and Dispensing Glove Box

1. Purpose:

To lay down a procedure for Operation and Cleaning of Glove Box used for sampling and dispensing.

2. Scope

The scope of this SOP is applicable for Operation and Cleaning of Glove Box used for sampling and dispensing at [company name]

3. Responsibility

Warehouse Person: To follow the Operation and Cleaning procedure of Glove Box.

Warehouse supervisor: Verification of Operation and Cleaning of Glove Box

Head warehouse: Ensure compliance to the procedure.

4. Definitions

NA

5. Procedure

• The glove box shall be used for sampling or dispensing for the material that require special precaution from the environment or potent materials that may require to be handled with extra precautions and has potential to have human safety hazards.

• Glove box has connections of nitrogen or relevant airline connection that will be required to be used during material handling.

• List of material to be sampling or dispensed in the Glove Box shall be maintained as per respective format.

• Operation of Dispensing Glove Box shall be done as follows.

• Open the Glass door and place required raw material container (closed condition), containers, polybag, and utensil in the glove box and close the door. (Note: Ensure that the door is opening and closing properly.)

• Switch ON the main power supply to Switch ON light and other functionalities.

• Ensure that required utility connection lines are provided, such as nitrogen line. Ensure that required filters are attached at inlet and outlet of airlines.

• Once the switch is ON, allow it to achieve the required conditions inside the chamber such as temperature, relative humidity (RH) and differential pressure. Until the required condition is achieved, glove box panel will show an alarm.

• Ensure that all indicators are in working condition.

• Once the required conditions are achieved, alarm will show green indicators.

• Sampling or dispensing activity shall be carried out through glove port.

• Sampling or dispensing activities shall be done as per instructions provided in the sampling sheet or batch manufacturing record respectively.

• While carryout the weighing operations in the glove port ensure that weighing balance is stable and readings are not fluctuating. Follow the good weighing practice while weighing operations.

• Once the sampling or dispensing activity is completed, complete the decontamination activities and collect the discards in the polybag. Perform double wrapping of polybag in which material to be discarded are kept to minimize the chances of hazard and contamination.

• After completion of operation Switch OFF the power and utility supplies.

• Record the activity details in the equipment log book.

• Ensure that the cleaning of equipment before and after every operation.

• Ensure that the required conditions are maintained throughout the sampling or dispense activities. Any excursions must be recorded and handled through applicable QMS system.

• Cleaning of dispensing glove box:

• Open the door of the glove box.

• Clean the surfaces inside and outside with dry lint free duster.

• Clean the surfaces inside and outside with disinfectant solutions [e.g. 70 %v/v IPA].

• Perform the decontamination of glove box surfaces.

• Decontamination of surfaces can be done using different decontamination agents. The selection of decontaminating agent is depending on materials based on studies done by R&D. List of decontaminating agents are available in respective format.

• Clean the inside area of glove box [inside walls, glass door, gloves etc.] with decontamination agent.

• After completion of decontamination, clean the these surfaces with dry lint free duster.

• Close the door.

• Record the details of cleaning and decontamination in the equipment cleaning logbook.

• Discard the Keep all the used dusters, wipes in double polybag, seal the bag, label it appropriately, and transfer it to respective locations for further processing of hazardous waste.

6. Frequency

During every operation and cleaning.

7. Formats

7.1 Equipment log book for dispensing or sampling operation and cleaning of glove box

Equipment Name:

Equipment Id. No.:

Date:    

Type of activity (Operation/ Cleaning)

Start Time

Product name/ Material Name 

Batch No./ A.R. No.

End time             

Done by

Checked by       

Remark

7.2 List of materials to be sampled and dispensed using the glove box

Name of material

Material Category

Permitted Daily Exposure Limit

Occupational Exposure Band (OEB) No.

Decontamination agent

Concentration of Decontamination agent

Instruction for use of material     

Regulatory Reference for usage of Glove Box:        

  1. https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/production/trs961-annex6-gmp-sterile-pharmaceutical-products.pdf?sfvrsn=61682f0c_0
  2. https://www.usp.org/frequently-asked-questions/radiopharmaceuticals

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