Pharmaco Guide

Cleaning and Operation of Sampling Booth

  1. Objective:
     To lay down the procedure for Cleaning and Operation of Sampling Booth.  
  2. Scope:This procedure is applicable for Cleaning and Operation of Raw Material Sampling Booth         used for Raw Material Sampling. 

  3. Responsibility: 
  1. Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Cleaning and Operation of Raw Material Sampling Booth in Quality Control Department as per this SOP. 
  2. Quality Assurance Department: To review and approve the SOP and Annexures. 
  3. Engineering Department: To carry out preventive maintenance as per schedule and procedure defined. 
  1. Accountability: 

            Head Quality Control Department, Head Quality Assurance Department 

  1. Procedure: 

Sr. No. 

Procedure 

 

  1.  

Safety Precautions: 

  1.  

Always use personal protective equipments such as nose masks and hand gloves while sampling, operation and cleaning of sampling booth. 

 

  1.  

Never stand in front of the RLAF when Ultraviolet light is ON as UV exposure can cause damage to eyes, cell damage, skin itching etc. 

 

  1.  

Do not perform cleaning activity when UV light is ON. 

 

   5.2 

Operation of Sampling Booth: 

  1.  

Ensure the cleaning of sampling booth is satisfactory and AHU is in running condition. Use 70% IPA for cleaning before starting the activity. 

 

  1.  

Switch ‘ON’ the RLAF unit after cleaning the unit and then switch ‘ON’ UV light of the sampling RLAF and pass box. Run them for minimum 30 minutes for disinfection.  

 

  1.  

After 30 minutes, switch OFF the UV light of the sampling RLAF and Pass box and note down burning hours in annexure. Start the air flow and check the differential pressure of RLAF on magnehelic gauge is between 10 mm – 20 mm as well as check the temperature and humidity maintained at 25±2oC and 55±5% in the area respectively.  

 

  1.  

In case, if the differential pressure or Temperature/Humidity conditions are not meeting the requirements, then intimate the Engineering Department and Head Quality Control.  

 

  1.  

Perform sampling of raw materials as per SOP ‘Sampling of Raw Materials” under RLAF. 

 

 

  1.  

Transfer all the containers/bags/drums from the quarantine area or Under Test area one at a time through the pass box into the sampling booth, draw the sample and return to the Under Test area after completion of sampling. 

 
  1.  

All the used equipment’s; accessories shall be removed from the sampling booth after use for cleaning. 

 
  1.  

Switch off the RLAF after 15 minutes of completion of sampling activity. 

 
  1.  

 Update the “Usage and Cleaning Record of Raw material Sampling Booth” as per define Annexure. 

 

  1.  

Label the sampling booth as “To be Cleaned” or if cleaning activity is going on, then label as “Under Cleaning” and start the cleaning activity. 

 

   5.3 

Cleaning Procedure of Sampling Booth: 

 

  1.  

Switch ‘OFF’ the RLAF before starting the cleaning activity. 

 

  1.  

Ensure that all documents and labels and accessories of previous material are removed from sampling booth. 

 

  1.  

Clean spilled dry powder or waste with soft brush or vacuum cleaner and collect in the waste bin. 

 

  1.  

Wipe the inside part as well as outside parts of the sampling booth properly in each and every corner with soft clean lint free dry cloth followed by wet cloth with water and finally wipe with wet cloth dipped in 70% IPA solution. 

 

  1.  

Wipe the floor and walls of sampling booth and pass box with clean soft lint free cloth, followed by wet cloth with water and finally with disinfectant solution such as dettol/savlon. 

 

  1.  

Clean the UV light and ordinary tube lights with soft lint free cloth.  

 

  1.  

After completion of the cleaning activity update the “Usage and Cleaning log of Sampling Booth” as per format number QC/003/F01 and label the sampling booth as follows:  

 

 

 

  1.  
After completion of the cleaning activity, switch ‘ON’ the UV light of Both Sampling RLAF and pass box for 30 minutes. Record in Annexure. 

 

  1.  

Cleaning of sampling booth shall be carried out at the start of the shift and after completion of sampling activity. 

 

5.4 

Validation of RLAF: 

5.4.1 

Frequency: Once in a year 

5.4.2 

Validation of RLAF shall be performed by external agency. 

 

5.4.3 

For validation refer SOP “Procedure for validation of LAF/RLAF” for parameters and acceptance criteria. 

 

5.5 

UV Efficacy Study of UV light tube in Sampling RLAF and Pass box 

5.5.1 

Frequency: Half Yearly 

 

5.5.2 

Perform Efficacy test of UV light Study as per define SOP 

 

     5.6 

Preventive Maintenance: 

5.6.1 

Perform the preventive maintenance as per define frequency. 

 

 

  1. Definitions / Abbreviations :   
  1.       Definitions : 
  1. Quality Control Associate: Analyst, Supervisor, Executive of Quality Control Department or any personnel trained to perform duties as per this SOP. 
  1. Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP. 
  1. Engineering Associate: Officer, Executive of Engineering Department or any personnel trained to perform duties as per this SOP.  
  1. Breakdown: Any activity leading to operation of instrument other than the set parameters or unusual sound or vibration observed in the instrument. 
  1. Preventive Maintenance: Maintenance activity performed to ensure that the instrument will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency. 
  1. Principle of Sampling booth:  

Sampling booth is used to control hazardous emissions of powder, dust or vapour during sampling, without risk to the operator or environment. They are constructed from stainless steel in fully ducted designs. The reverse laminar flow booth is made from stainless steel. A negative pressure inside the booth prevents the escape of fine powder from the work area towards the external environment. Downward airflow provides full protection to operator and product. It minimizes the risk of contaminating the work zone ensuring health and safety of people working with the chemical/powder. Reverse laminar air flow operates on the principle of providing containment of contaminated air by air movement. Pre filters capture airborne contaminants in the rear of the room or hood, and the velocity of the air entering the filters is accelerated to reduce the number of particles that recirculation into the room.  

  1.      Abbreviations : 

Abbreviation 

Expansion 

QC 

Quality Control  

QA 

Quality Assurance  

SOP 

Standard Operating Procedure 

PVC 

Poly Vinyl Chloride 

RLAF 

Reverse Laminar Air Flow 

LAF 

Laminar Air Flow 

± 

Plus or minus 

% 

Percentage 

oC 

Degree Celsius 

mm 

millilitre 

AHU 

Air Handling Unit 

UV 

Ultra Violet 

IPA 

Isopropyl Alcohol 

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