Understanding expectations for validation of unidirectional air flow studies smoke studies

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1 Understanding expectations for validation of unidirectional air flow studies smoke studies Juan M. Rodríguez, CQA, MBA Validation Manager, Biologics Mfg. & PD Bristol-Myers Squibb, Syracuse, NY

2 Agenda Introduction Regulatory expectation Overview of Airflow Visualization program Key point to remember Smoke study summary diagram Warning letters Back up slides 2

3 Introduction Airflow visualization (AFV) studies; demonstrates unidirectional airflow pattern (characteristic) on critical areas ( mainly ISO Class 5) Why are we still doing them? Perform mainly on new installation and existing ones when changes are done. Perform periodically to demonstrate no changes on airflow characteristics (YouTube image) 3

4 Introduction: Why? It is the documented evidence to demonstrate that the design, procedure and operation of a clean room/critical processing zone meet predeterminated criteria to reduce risk of cross contamination. It demonstrate appropriate interaction between Operation Procedure Personnel Operation Procedure Personnel 4

5 Introduction: Where is required? Class A/ISO Class 5; Filling Lines (e.g. Vials, Syringe) Loading/unloading (e.g. Freeze Drier) Biological Safety Cabinets (BSC) Unidirectional Airflow Modules (UAM) Restricted Access Barrier System (RABS) Other areas classified as Critical Areas where product/material might be exposed to open environment that are not ISO class 5 5

6 Regulatory expectations FDA Procedures (e.g., aseptic connection) that expose a product or product contact surfaces should be performed under unidirectional airflow in a Class 100 (ISO 5) environment - Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice, FDA Eudralex It should be demonstrated that airflow patterns do not present a contamination risk, e.g. care should be taken to ensure that air flows do not distribute particles from a particle generating person, operation or machine to a zone of higher product risk -Annex 1 Manufacture of Sterile Medicinal Products (corrected version) 6

7 Regulatory expectations (cont d) Standard/Guidelines frequently used: International Organization for Standardization (ISO) ISO-14644, 1-4 USP 797 (compounding sterile) NSF 49 (BSC, design, construction, performance and field certification) 7

8 Regulatory expectation: how to meet it? In summary!! Pre requisites Protocols required Cross functional team Execution Recording Review approval Simple!! Plan Execute Close 8

9 Overview- Smoke study program Design qualification Validation plan Procedures Static/Dynamic equipment Plan (what) Perform (how) Reassess (state of control) Review (agree) Revalidation frequency certification EM reassess Review videos Acceptance criteria 9

10 Plan-prerequisites What are we going to do? Validation life cycle (VP,URS, DQ, IOQ etc) Understand your system Define critical areas Risk assessment Product contact surface Classification Product contact Material Define application Type of protection (ISO ): Product Personnel/environmental Personnel/product/environmental 10

11 Plan-prerequisites (cont d) Define engineering controls HVAC qualification Balancing report Air velocities HEPA/ULPA certification Air changes per hours Pressure cascade Facility design Unidirectional or Laminal (vertical or Horizontal) Structural design Define Administrative/Procedural controls Procedures Personnel Personnel flow Product Flow Waste flow Material flow 11

12 Plan-prerequisites (cont d) Typical Layout of Critical areas Adjacent Background area ISO 8/9 Barrier ISO 7- barrier ISO 6 UAM (ISO 5) BSC (ISO 5) 12

13 Perform getting ready Sequence of operation What has to happen first? Are we ready Acceptance criteria Procedures Do we have the right equipment to do this? Choose the smoke generation system Pulse or continuous List of instruments List of activities List of interventions HVAC Qualification Facility Balanced Equipment Qualification completed Material defined Certification completed Do mock up runs first, do not go without testing!!! Personnel SOP defined Max allowable Personnel trained 13

14 Perform getting ready (cont d) Protocol approval People trained on the SOP and MBR Layout and set up Background Smoke rack Schedule (time) 14

15 Perform getting ready (cont d) Smoke generator Continuous- provide a smoke stream more efficient sometimes less than usual Pulse- it has a delay, pulse can sometimes push the air in the wrong direction Dry ice, liquid nitrogen- create a low lying fog effect, watch out for false flow. Safety concern; displace oxygen, asphyxia (CO2 fog Image Titanium Tetrachloridecontinuous for around 5 to 10 minutes. Safety Concern; Irritant to human skin and lungs(tel-trueimage, Fog Machine- use a mixture of water and Glycol releasing water vapor. Varied application less safety concerns. (Images and ) 15

16 Perform-execution Execution 2 conditions: Static- (at rest) all equipment, ancillary and sampling equipment in the area, but no operation/processing running Dynamic- (in operation) processing or simulated processing activities occur. Filming is an art, get somebody with expertise. Be aware of B.R.A.D Background Reflection Angle Direction 16

17 Perform-execution (cont d) Considering worst case conditions: Operation: Equipment at maximum stress (e.g. high speed, filling line) Bigger packaging materials (e.g. bottle) Maximum a amount of instrument in (e.g. BSC particle counter) Personnel: Maximum allowable personnel More sampling activities Procedure Maximum amount of interventions Maximum amount of manipulations 17

18 Perform-execution (cont d) Filming: Static 18

19 Perform-execution (cont d) Filming: Dynamic 19

20 Perform-execution (cont d) Desire characteristic: Static: Clean visual of smoke sweep throughout surfaces Smoke flowing from the source to the exhaust in one direction No instrument or equipment interfering with the smoke path Demonstrate cascade with adjacent rooms Parallel smoke characteristic at working level Operation, Same as static in addition; Operation of equipment, human manipulation interfering with the path of smoke. Rapid restore of the smoke once interrupted Interventions are not creating uni-directionality disturbance Smoke study should capture the disturbance effect and recovery Maximum allowable personnel effect 20

21 Perform-execution (cont d) Once execution is completed: Clean and Organized the facility and equipment Make sure you clean (heavy clean) to remove residues from smoke generator used. Sanitize the areas a equipment following regular and validated procedure Test for viable and non-viable Document it all as part of the protocol 21

22 Review-recording Who is reviewing? Owner Engineering/facilities Validation QA One of the most important part of the study is this. Acceptance for its application Clear evidence to show to regulatory agencies Demonstration of your aseptic techniques, a glimpse to the actual process Document the process after everybody agreed But, what are we looking for? 22

23 Review-recording (cont d) Static Evaluation AREA RESULTS (PASS/FAIL) Outside air curtain or perimeter (working area entry point) of BSC in front of the work opening. Inside air curtain (immediately behind working area entry point) of BSC inside and in front of work opening. Sweep across plenum, with emphasis on lights, joints and other impedances Across work surface (including equipment/items present for dynamic also needs to be present for static study) Pass Pass Pass Pass 23

24 Review-recording (cont d) Dynamic Evaluation Activity SOP/M BR Description Performed During Video? (Yes/No) Cell Culture Scale-Up Pre-Set Up X-X-ZZ Step 2.2 All items, including gloved hands, will be disinfected with 70% IPA prior to entering the work area. Yes Environmental Monitoring X-X-Z1 Step 2.4 If not already in position, place SAS unit, settling plates, RODAC plates and the particle counter probe inside BSC. Yes Set up and Scale-Up X-X-Z2 Step 2.6 Position the appropriate material containers and scale-up equipment inside the BSC. Materials to include pipettor, pipettes, two 2 L bottles of dyed WFI, one 3 L shake flask of dyed WFI, and three 3 L empty shake flasks. Additional supplies to include sterile gauze. Yes Pour the dyed WFI from the 2 L bottles into empty 3 L shake flasks. Yes N/A N/A Open and the door between rooms 345 and 346, 347 pass-thru door and the door between rooms 348 and 349 during activities. Yes 24

25 Review-recording (cont d) Evaluation: watch out for undesirable conditions Pattern Reflux Upward Flow Turbulence Stagnant Billowing Eddy Current Description Recirculation of air within the prevailing downward airstream. The smoke remains downstream of the air source. Movement of air back to near the source of the airflow, at which point the smoke re-enters the airstream. Tight circular patterns that originate on the trailing edges of surfaces or other objects. Absence of airflow in which smoke remains in one area and is not drawn into the airflow. Significant horizontal spreading or expansion of the air stream. Whirlpool or spiraling as air moves downward. 25

26 Reassess - State of control Revalidation Boundaries Static and Dynamic Per product/procedure Establishing a frequency for revalidation Typically 24 months or more Re-certification of areas Ensure you go along in the same timing for area/hepa filter certification Do we really need a protocol for revalidation? 26

27 Key point to remember 1. If you believe the unidirectionality is not clear, repeat it!! do not leave it to interpretation. recorded good enough is not an option!! 2. Awareness of changes impacting smoke studies changes to facility maximum allowed personnel operational procedures Changes to equipment (e.g. speed) New product or new packaging (e.g. vials) significant changes to airflow (e.g. velocity) 3. During the execution of the studies, include interventions (e.g. mechanical or routine) 27

28 Key point to remember cont d 4. It is a regulatory expectation that you: Maintain videos on the most current format Reassess state of control frequently Demonstrate appropriate cleaning after studies (e.g. particles, cfu according to specific classification) follow your procedures for manufacturing operations during studies, it is a reflection of your current operation. Avoid deviations 5. Appropriate sequence of operation occur from A to Z 6. Important to put the steps to be challenged on the protocol 7. Be prepare to review videos with inspectors (Make SMEs in your department) 28

29 Key point to remember cont d 8. Do not forget the dynamic worst case conditions discussed here in. 9. Do structured plan/program to challenge new or existing critical areas. 10. During the execution do mock ups to check for B.R.A.D 11. Be aware of changes, rely on your change control system. Have the appropriate validation representative there to assess the impact to validate state. 29

30 Execution summary flow No Construction Equipment/ Facility IQOQ Certification Balancing Report, PQ Prerequisites -Protocol -Personnel -Procedure Mock up runs Acceptable Yes Start Execution Completed Revalidate frequently Preview Execution Videos VS, Eng, Mfg,QA Passed Release for use/return to Services Approve final report Clean/ Sanitize/ monitor 30

31 Warning letters Remarkable Observation evaluation Company in, India 16-Sep-08 Company in India May 7, 2009 Company in GmbH 2/9/11 Company in Gmbh 12/17/12 Company in Canada, 2/21/13 Company in USA March 31, 2015 Company in USA, August 6, 2015 Company in Germany, Oct 22, 2015 Company in India, Dec

32 Interactive Activity Exam!! True/False 1. Attention to details is the key for a good smoke studies validation? True 2. Smoke studies can be performed on whatever sequence and there is no impact to the studies validity? False 3. Brad is a cool name that does not mean anything for filming unidirectional airflow studies based on this presentation? False 4. During this presentation we have learned that while filming B.R.A.D stand for? Background, Reflection, Angle and Direction True 5. Once we do an airflow visualization study, and is all approved, we don t have to do anything else unless there is changes? False 6. Interventions are not required to be include on the smoke study as long as they are included on the SOP or MBR? False 7. Even if I don t have my glasses I can review the smoke study video and approved it? False 8. Smoke studies are a regulatory requirement of FDA only False 32

33 Back up slides Use tools out there for examples: e.g. Mock up 1: Mock up 2: Filling line: 33

34 Q&A Thank you for your attention!!! 34

35 Main reference NSF/ANSI International Standard/American National Standard Unites State Pharmacopeia (USP) <797>: Pharmaceutical Compounding-Sterile preparation International Organization for Standardization (ISO) Cleanrooms 35

36 Speaker Bio Juan has over 16 years of leading experience among recognized Fortune 500 Companies in Biopharmaceutical/Pharmaceutical industry. With strong background in parenteral product, sterilization, equipment and utilities for aseptic processing, he has been able to master project implementation and maintenance of validation systems for companies like Bristol-Myers Squibb, Bausch and Lomb, Amgen and Pfizer, among others. Juan holds a BS in Biology from University of Turabo in Puerto Rico, a Masters in Manufacturing from Polytechnic University in Puerto Rico, and Masters in Business Administration (MBA) from Simon Business School, University of Rochester in New York. Juan is a quality oriented person who hold a quality auditor certification from American Society for Quality (CQA-ASQ) and is very passionate about system quality attributes to ensure product efficacy and patience safety. 36

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