Process validation of filling and sealing of parenteral

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filling and sealing of ampoules.

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Process validation of filling and sealing of parenteral product:

Process validation of filling and sealing of parenteral product Abhishesh kumar Mehata M.pharm , IIT BHU,varanasi

Slide2:

Design qualification Facility Design Area Basic installation area for equipment varies accordingly to model and company requirements. Total area 21-29 meter sq. 2. Grade A(Class 100) 3. HVAC system temperature and humidity same as compounding area a . Pressure Differential : Pressure difference between classified rooms – 10- 15 Pa b. Air change rate : For ISO Class 5 – 20 Air changes/hr . (minimum)

Slide4:

Equipment specification

Slide5:

Salient Features : Compact cGMP model Different models ranging from 1800 ampoules/hour to 12000 ampoules/hour All contact parts made from High Quality Stainless Steel 316L & Noncontact parts made from Stainless Steel 304 Minimum change over parts from 1ml to 10ml ampoule size “No Ampoule – No Filling” system Ampoule neck centering during gas flushing and filling operations Possibility of nitrogen gas flushing before, during and after filling Full accessibility allows easy maintenance

Slide6:

At filling station 1.SS ampoule feeding hopper( 1ml to 10ml with suitable parts) 2.SS syringe pump 3.SS drip proof feeding needle 4 .Pre-gasing needle 5.Post-gasing needle At sealing station 1.SS Racks(holding ampules) 2.SS plunger 3.Rotation roller 4.SS tray (speed of machine depends upon no. of filling head, viscosity of solution, pressure at which solution pumped and size of ampoules to be filled)

Slide8:

Installation qualification The qualification involves, Verification of approved purchase order Verification of invoice Check manufacturer and supplier Verification of model number and serial number Checking for any physical damage Confirm location and installation requirements as per recommendation of manufacturers Verify that the utilities required are available Installation shall be conducted as per instructions provided in the manual

Operational Qualification:

Operational Qualification O.Q. is verification of performance of the system without load O.Q. involve, Verification of alarm control Perform calibration requirements identified in the manual Operate the equipment at low, medium, and high speed as per operations manual to verify the operating control Verify that all switches and push buttons are functioning properly Establish procedures (SOP) for operation, maintenance, and calibration Establish training program for relevant staff 15 February 2016 9

Performance Qualification:

Performance Qualification P.Q. is verification of performance of system with load Filling studies will be run on all containers and fill levels The containers will be filled in triplicate runs If a placebo is used, it should have similar physical characteristics (viscosity, density, foaming) to the actual fill materials The study should be run at minimum, maximum and intermittent speeds (in terms of ampoules/minute) The filler must handle the containers without damage and without jams Accuracy and precision must meet specifications 15 February 2016 11

Slide12:

P.Q. of ampoule filling and sealing machine involve, Wight variation test Filling volume accuracy Particle Contamination Leaker test Oxygen content 15 February 2016 12

Slide13:

Weight variation test : In the absence of specific criteria, weight variation must conform to USP In summary, all 10 units must be within 85.0 to 115.0% of target content, or not more than 1 of the 30 units outside of the 85.0 to 115.0% and no units outside of 75.0 to 125. 15 February 2016 13

Continued…..:

Continued….. Filling Volume Accuracy: The filling accuracy should be within ±% of the adjusted and desired filling volume in accordance with the machine specification. eg . Attention limit: ±1% Action limit: ±2% 15 February 2016 14

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