Entry & Exit procedure for Clean Area Filling Room

Entry & Exit procedure for Clean Area Filling Room

1.0     PURPOSE:

To provide the written procedure for entry & exit for clean area Filing room.

2.0.     SCOPE :                                  

This SOP will be applicable for authorized staff & visitor’s movement in clean area   filling of SVP section.


3.1        References

3.1.1     In-House

3.2        Attachments

3.2.1     Attachment-I: Authorized Person list for Filling area

3.2.2    Attachment-II: Pictorial Diagram for entry & exit for staff & visitor


4.1       Concern Department Person

4.1.1    To follow this SOP for entry & exit for clean area Filling room.

4.1.2    To Maintained the record.

4.2       Production  Head

4.2.1    To verify that employees are trained before performing or operation any task relevant to this SOP.

4.3       Quality Assurance Persons

4.3.1    To verify that all the instructions are followed properly as per  given SOP.

4.3.2   To ensure implement of the SOP.


  1. Production
  2.  II.   Quality Assurance


6.1       Definition

Clean Area: Clean area is the area in which defined environmental control of particulate & microbial contamination, constructed & used in such a way to reduce the introduction, generation & retentions of contaminants within the area.

6.2       Abbreviations

6.2.1    SOP                : Standard Operating Procedure

6.2.2    QA                   : Quality Assurance

6.2.3    SS                   : Stainless Steel.

6.2.4    IPA                  : ISO Propyl Alcohol

6.2.5    LAF                 : Laminar Air Flow

7.0        PROCEDURE:

7.1        Entry & Gowning Procedure in the clean area Filling Room

7.1.1     To entry in the clean area filling room, enter in the classified production corridor with  proper entry procedure as per SOP.

7.1.2     For the authorized staff to enter in first air lock use biometric access control system (finger detection) system & for visitor make entry in the entry/exit record for investigation purpose.

7.1.3     Outside party person, visitor or untrained person shall be accompanied with  authorized & make entry in visitors entry/exit record.

7.1.4     After entering in first air lock of clean area filling remove the factory ware, personal  ware (except under garments) & clean area slipper & keep in the assigned place in SS dress cabinet with proper manner & sanitize hands with hand sanitizer & dry atmospherically as per step I of pictorial.

7.1.5     Enter in the Personnel Air Lock-II by opening the respective  door with elbow as per  step II.

7.1.6     Open the dynamic garment storage cabinet, wear sterilized primary gloves & collect (green colour ) clean primary gowning containing shirt, trouser & cap from the cabinet & wear it as per step III of pictorial.

7.1.7     Sanitize hands with IPA 70% v/v solution & swing over the cross bench & enter in Personal air lock-III by opening the respective door as per step IV.

7.1.8     Open the dynamic garment storage cabinet, collect the  sterilized  dacron gowning bag (green colour ) from the cabinet.

7.1.9     Open the bag & first wear sterilized headgear, ensure that all hairs are covered.

7.1.10    Wear sterilized dangri tucking headgear inside neck of gown. close the zip of dangri.

7.1.11    Wear booties tucking lower portion of gown inside the booties. Be carefully during gowning, it should not touch on the floor. wear clean area shoes from cabinet as per  step V.

7.1.12   Wear secondary gloves as per step VI.

7.1.13    If the gowning found torn or dirty or not fit to the body keep it in SS “ USED GARMENT  BIN”. 

7.1.14   Check yourself in front of mirror for proper gowning & avoiding any expose body parts as per step VII.

7.1.15   Sanitize hand with IPA 70% v/v, sit & swing over the cross bench as per step VIII.

7.1.16   Enter in air lock IV by opening door, wear sterilize safety goggles & sanitize hands with IPA 70% v/v solution as per step IX.

7.1.17   Enter in filling room by opening the door of same.

7.2        Exit & de-gowning Procedure from the filling Room

7.2.1     Enter in Personnel air Lock-V through air lock- IV  by opening  respective door in return way, remove clean area shoes & keep inside cross bench as per step X.

7.2.2     Remove primary & secondary gloves & keep in SS waste bin.

7.2.3     Remove clean area booties, dangri, hood & keep the gowning in used dress bin subjected for washing as per step XI.

7.2.4     Swing over the cross bench & enter in personnel air lock-I by opening the door as per step XII.

7.2.5     Collect personal ware, factory ware & factory shoes from SS cabinet & wear the same & exit from the first air lock as per step XIII.

7.2.6     Every day get the print of biometric access control system from the connected computer system for verification & identification of personal movement & attach in file.

8.0      REVISION HISTORY:                                            

Version No. 00 Effective date

Detail of revision: New SOP

 Attachment – I

Company logo Company name & address
       Authorized Person List for Filling Area Page No.: x of y


Sr. No. Name of person  





Prepared By                               Checked  By                                  Authorized By

Attachment – II

Company logo Company name & address
       Pictorial Diagram for entry & exit for staff & visitor’s Page No.: x of y


About Pharmaguidanaces Channel

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also


VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of …