SOP FOR RESUMING OF ASEPTIC AREA AFTER MAINTENANCE ACTIVITIES
SOP FOR RESUMING OF ASEPTIC AREA AFTER MAINTENANCE ACTIVITIES
PURPOSE : To provide written procedure for resuming of aseptic area after maintenance activities.
SCOPE : This SOP shall be applicable for resuming of aseptic area after maintenance activities at SVP section.
REFERENCE(S)
FDA and schedule M
CROSS REFERENCE DOCUMENTS
Document(s) and Data Control Procedure
Training Program for Employees
Entry & exit procedure for manufacturing room of SVP section
Entry & exit procedure for filling room of SVP section
Cleaning & sanitization of classified/clean area
Monitoring of non-viable particle count in classified area of SVP section
General preventive maintenance of machine & equipments
Filter cleaning procedure
DEFINITION & ABBREVIATION(S)
DEFINITIONS
Aseptic Area is a room or special area within the clean room designed, constructed, serviced & used with the intension of preventing microbial contamination of the product during production because it can’t support the growth of micro-organism.
Preventive Maintenance: Maintenance performed on regular basis to reduce the likelihood of failure. It is also called planned maintenance. It is conducted throughout an assest in normal operating condition.
Current Good Manufacturing Practices (cGMPs): cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
ABBREVIATIONS
cGMP : Current Good Manufacturing Practice
SVP : Small Volume Parenteral
IPA : Iso Propyl Alcohol
AHU : Air Handling Unit
UV : Ultra Violet
CIP : Cleaning In Place
SIP : Sterilization in Place
FFS : Form, Fill & Seal
RESPONSIBILITY
Originating department shall be responsible:
Initiating, preparation, review and revision of the SOPs.
To provide the final draft copy to Quality Assurance.
To follow the described here in.
To provide training to concern company employee & outside visitors to work in aseptic area.
To arrange gowning & all accessories for entry in aseptic area.
Head of Originating department/designee shall be responsible for:
Checking of the SOP for procedural, technical content, accuracy and cGMP compliance.
To verify that employees are trained before performing any task.
To verify that outside person or visitor not adhering the clean room behavior.
To ensure the compliance of SOP.
Quality Assurance department shall be responsible for:
To checking of the draft SOP for technical, function, regulatory and cGMP compliance prospective.
To verify that employee or outside visitor following the entry/exit procedure & clean room behavior.
To verify the cleaning & sanitization of area after maintenance work.
To verify that only authorized maintenance person entering in the area.
Head – Quality Assurance/ Designee shall be responsible for:
To approve new or revised SOP.
To verify that all employees are following the aseptic behavior & area is maintained after maintenance work.
To provide final approval to start the aseptic area after maintenance work.
To ensure the implementation of the defined system.
Engineering person shall be responsible for:
Co-ordinate with production person for schedule preventive maintenance or break down maintenance of aseptic area machine or equipment.
To follow the clean area entry/exit procedure during entry of aseptic area.
Plant Head shall be responsible for:
To approve new or revised SOP.
To ensure the implementation of the defined system.
PROCEDURE:
SAFETY/PRECAUTION/EHS
Before entry in clean area/aseptic area follow the entry exit SOP to avoid any outside contamination in the area.
Switch off the equipment/instrument/machine during maintenance work to avoid any mis- happening.
Follow the safety rules as per respective SOP during performing maintenance work.
First aid box should keep in production department.
PREVENTIVE MAINTENANCE IN ASEPTIC AREA
As per the planned maintenance schedule the maintenance person will give prior information to respective department on written request elaborating the availability of machine.
Production person will prepare the schedule to handover the machine to maintenance department.
During preventive maintenance production operation will strictly not be performed.
Production person will remove all sensitive components near the area or machine where maintenance activities will be performed.
Production person will close all openings of lines, sampling valves, main hole of tanks near the maintenance activities.
If maintenance activity is in FFS machine attach the mandral hood on the filling nozzles & run continuously LFR of machine.
Only trained & authorized (personally qualified) engineering person will be allowed to enter in aseptic area to perform maintenance activities.
During maintenance work in aseptic area/clean area AHU should be run at all time.
The maintenance person will follow the to enter in the aseptic area.
Maintenance person will transfer all maintenance tools in clean area by wrapping in poly bag with complete sanitization with IPA 70% v/v solution.
Keep this poly bag in dynamic pass box under exposure of UV light for disinfection & then other area person will collect the polybag containing maintenance tools.
During maintenance work all maintenance personal will take care of spillage of oils, grease or any other material falling on floor and walls.
He has to keep sanitized empty poly bag or bin to keep the waste.
After completion of job he will discard the polybag outside of clean area.
After completion of maintenance work production person will transfer the maintenance tools outside the aseptic area through the same pass box.
Afterwards operator will clean & disinfect the pass box inside and outside.
After leaving the aseptic area the maintenance person gowning will be shifted to washing area immediately.
Operator will clean & disinfect outer body of the machine with IPA 70% v/v solution.
He will clean & disinfect the complete area with schedule disinfectant solution.
Make complete fogging in work place & aseptic area for at least 2 hours.
BREAK DOWN MAINTENANCE
Break down maintenance involve minor maintenance, adjustment or alteration to ensure that process and parameters are within limit.
Minor maintenance can be performed by operator itself.
If the break down is of significant nature follow the below mentioned procedure.
Remove all filled & sealed ampoules/containers from the filling machine.
Carryout required maintenance activities.
Remove all the spillage material oil, grease, waste material in sanitized polybag & transfer outside for discard.
Take dummy/empty trial of machine to verify that all the concerned parameters are working as per specification.
After satisfactory result clean & disinfect the machine with IPA70% v/v solution.
Clean & disinfect all aseptic area with scheduled disinfectant solution.
Replace the gloves with new sterilized gloves & sanitize hands with IPA 70% v/v. if gowning is also get dirty during maintenance work replace with sterilized gowning.
Perform CIP/SIP of machine if break down is more than 4 hours.
Perform particle count as per SOP if particle count within limit get the line clearance from QA department & prepare the machine to start further processing.
PROCEDURE FOR RISER FILTER DISMANTLE & ASSAMBLING OF ASEPTIC
AREA
During schedule cleaning of return riser filter of aseptic/clean area & other equipment filters, production person will give intimation to engineering through work order prior to one or two days.
During return filter dismantling AHU system of clean area will be stop & no production activities will be performed.
For manufacturing room, filling room (Class C) return riser filter production operator as well as authorized engineering person will dismantle all return filters one by one & transfer to unit preparation room for cleaning.
After proper washing & drying clean filter will be properly sanitize with IPA & transfer in manufacturing room or filling room for assembly.
Before start operation keep the area under deep fumigation for at least 4 hours.
Maintain the filter cleaning log book.
For class D area , C&C area, corridor, janitor room & day store room return riser filter cleaning production operator authorized engineering person will dismantle all return filters & keep in clean double poly bag close with tie, & transfer to service floor for washing of filters.
After proper washing & drying clean filter will be transfer in clean area in double poly Bag.
Before transfer to clean area first outer poly bag will be properly sanitize with IPA in change room & then it will transfer to clean area.
Before assemble, return filter will be sanitize properly with IPA solution & store in unit preparation room under deep fumigation for at least 4 hours.
After de-fumigation return riser filter & equipment filter will be attach & maintain the log book of filter cleaning.
REVISION HISTORY