How to Handle Excursions in Environmental Monitoring (EM) and Personnel Monitoring (PM) in an Aseptic Processing Plant

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1 How to Handle Excursions in Environmental Monitoring (EM) and Personnel Monitoring (PM) in an Aseptic Processing Plant Randy Hutt, Ph.D. Associate Director Sterility Assurance and Microbiology Luitpold Pharmaceuticals, Inc. July

2 Introduction EM/PM excursions are environmental or personnel results that exceed established alert or action levels. EM excursions should not be the sole determining factor used to release or reject batches without further evaluation. Excursions leading to trends should be used to help determine what corrective/preventive actions are needed for microbial control. EM/PM excursions are referred to as being Out of Limit results not Out of Specification results. Examples of OOSs would be exceeding specifications for bioburden or endotoxin, and having growth in a sterility test. 2

3 REFERENCES 1. USP General Chapter (current Version 38) <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments 2. Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products (corrected version) Effective March 1, Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice PDA Technical Report No. 13 (Revised) Fundamentals of a Microbiological Environmental Monitoring Program 5. International Organization for Standardization (ISO) Cleanrooms and Associated Controlled Environments 6. WHO Technical Report Series, No. 961, 2011 Annex 6 WHO good manufacturing practices for sterile pharmaceutical products 3

4 War Stories Gram negative organisms Batches rejected due to microbial contamination Gram negative organisms on the floor: Microorganism identified from a contact plate. An investigation was performed. Since the organism is a gram negative, it was most likely a water borne organism. Inspection of the aseptic area was performed and pooling water was identified as the most likely source of contamination. The suspected source was sampled using RODAC plates and swabs. Results confirmed suspicions. Root cause was confirmed and as a follow up a CAPA was created. The CAPA included a fix to the slope of piping of jacket water towards the non sterile manufacturing area from the sterile area and also correcting a lack of air breaks to drain. No more Gram negative organisms were isolated. 4

5 War Stories Gram positive spore formers Found Gram positive spore formers around aseptic area in manufacturing plant situated in a rural area. An investigation was performed. The organism was identified as a spore former (Bacillus). Usual sources are likely found in soil, cardboard boxes, wooden pallets, and raw materials. Due to the rural location of the plant, many employees lived near/on farms. The most probable Root cause identified as personnel tracking into the aseptic area on non dedicated shoes. CAPA was initiated to created procedural controls to provide dedicated shoes for employees entering the aseptic processing area. This greatly reduced finding these organisms in the aseptic area. 5

6 Sterility Testing Is the testing of 20 or even 40 samples as required in a nondestructive sterility test sufficient to provide assurance of sterility? This test is simply a probability function, because a large amount of contamination would need to be present in a batch of 100,000 units to detect it in only units. Therefore, it is critical to control the environment with Engineering Controls (# of air changes per hour/laminar Air Flow, etc.) and to test the Environment and the Personnel for possible contamination and provide assurance of sterility. 6

7 Environmental Monitoring Types of Environmental Monitoring includes: As built / commissioning EMPQ At rest testing (Static) Operation testing (Dynamic) Types of sampling includes: Viable evaluating for living organisms Active Passive Surface Non viable Total airborne particulates Continuous (PMS fixed units) Total particulate (Lasair portable units) 7

8 Performance of Non Viable Monitoring: There are 2 types of non viable methods that are used in an aseptic filling facility and monitor both 0.5 µm and 5.0 µm. Continuous real time monitoring is performed using fixed probes. For example Particle Monitoring System (PMS). Total particulate monitoring is also performed using portable Lasair units. Portable Lasair units are placed at specified locations where sampling is needed. It is helpful to use hand held units to discern where particulates are being generated in the case of any alarms due to high particulate levels. 8

9 Non Viable Testing The purpose for Non Viable sampling is to: Verify room classification when an area is new. Evaluate air cleanliness, ensuring compliance, during normal operations and to ensure recovery time at rest after min. In Grade A and B zones, the monitoring of the 5.0 µm particle concentration count takes on a particular significance as it is an important diagnostic tool for early detection of failure. The occasional indication of 5.0 µm particle counts may be false counts due to electronic noise, stray light, coincidence, etc. However, consecutive or regular counting of low levels is an indicator of a possible contamination event and should be investigated. Such events may indicate early failure of the HVAC system, filling equipment failure or may also be diagnostic of poor practices during machine set up and routine operations. Reference is Annex 1, Page 4, #13. 9

10 Viable Monitoring (more details): a) Active air sampling Using air sampler Quantitative Assesses air quality in the controlled environment specified volume > 1 m 3. Active air sampling is performed by using SAS air samplers, RCS, or other sampler which pulls in a specific quantity of air for a specific time. b) Passive air sampling Using Settle plates (90mm) Quantitative Assesses air quality in the controlled environment over prolonged exposure times. Settle plates are placed on the designated surface for a specific length of time. (e.g., Filling machine inside a fill room or on settle plate stands). Per Annex 1, individual settle plates may be exposed for < 4 hours. c) Surface sampling Using RODAC plates (55mm) Quantitative or Swabs Qualitative Checks cleaning effectiveness and environmental control. Personnel Monitoring (PM) sampling (Using RODAC plates) Quantitative Evaluates aseptic technique and possible impact to aseptic controls. RODAC plates are touched/pressed against specified locations on aseptically gowned personnel (e.g., gloved fingerprints, forearms, and chest). 10

11 US Requirements/Limits NVP for classification (ISO 14644) VP for EM and PM C.R.R per USP <1116>. ISO Class NVP >=0.5 micron/ m3 >=5 micron /m3 ISO 5 3, ISO 6 35, ISO 7 352,000 2,930 ISO 8 3,520,000 29,300 Room Classif. VP AA SP CP or Swab Glove/ Garment ISO/Rabs < 0.1% < 0.1% < 0.1% < 0.1% ISO 5 < 1% < 1% < 1% < 1% ISO 6 < 3% < 3% < 3% < 3% ISO 7 < 5% < 5% < 5% < 5% ISO 8 < 10% < 10% < 10% < 10% 11

12 EU Requirements NVP Max. permitted # particles/m³ = or greater than tabulated size At Rest In Operation Grade 0.5 µm 5.0µm 0.5 µm 5.0 µm A 3, , B 3, , C 352,000 2,900 3,520,000 29,000 D 3,520,000 29,000 Not Defined Not Defined Grade VP per Annex 1 Rec. Average AA SP CP Glove A <1 <1 <1 <1 B C D

13 Alert and Action Levels/Limits for Viables Alert Levels (Determined by each company): Microbiological levels, specified in the SOPs, which when exceeded should result in an investigation to ensure that the process is still within control. Alert levels are specific for a given facility and are established on the basis of a baseline developed under an EMPQ. These alert levels can be modified depending on the trend analysis done in the monitoring program. Alert levels are always lower than action levels. Action Levels (Specified in USP <1116> and Annex 1): Microbiological levels in the controlled environment specified in the SOPs, which when exceeded must trigger an investigation and a corrective action based on the investigation. 13

14 Alert Levels How to determine Alert levels: Are statistically determined by history and trend analysis usually mean + 2 SD; Lower than action level and determined by 100 data points (or a year of data sometimes). An alert may or may not trigger an investigation; define in SOPs. 14

15 Contamination Recovery Rates per USP The Contamination Recovery rate is the rate at which environmental samples are found to contain any level of contamination. For example an incident rate of 1% would mean that only 1% of the samples taken (e.g., 1 of 100 samples) have any contamination regardless of colony number. This rate should be based on actual monitoring data and should be retabulated monthly. Contamination Recovery Rate = Total number of Samples with recovery Total number of samples (100) 15

16 Most Probable Number Method (MPN) Most probable number method, otherwise known as the method of Poisson distribution with many zeroes, and is a method of getting quantitative data from negative incidents. Recommendation from USP <1116> on Contamination Recovery Rates, is an article by Scott Sutton, where he discusses the MPN approach as a method given the Poisson distribution of the data and very low numbers of samples. (MPN) = * Log (10) Total number of sampling Number of sampling yielding zeroes 16

17 When to write an investigation USP vs. EU For Viable Recoveries Note: Limit of detection on a plate= 1 CFU (EU requirement for investigation in Grade A) Limit of quantification = 25 CFU per plate (e.g., CFU/plate) Therefore, EM Alert and Action Levels of 1 10 CFU are of questionable accuracy (background noise). Significant excursion is approximately 15 CFU (USP). How to handle CFU?? Thus the USP monthly recovery rate was developed and is appropriate to use to look for trends both prior to a recovery and monthly. 17

18 Internal QC Lab Investigation for Viable Recoveries Investigation Methods: Fishbone method: Method, Materials, Equipment, Environment, Personnel, Process 5 Whys: Keep asking why 5 times Kepner Tragoe Analytical Trouble Shooting: Compare differences of where the problem is and where it is not Use of Risk Assessment Methods to determine Severity of Microbial contamination should it have occurred, the Likelihood of it occurring, the ability to Detect it. 18

19 Example Fishbone Diagram of Cause and Effect for Potential Causes of Contaminated Producthttp:// 19

20 QC Microbiology Data for Investigation Identify non conforming sample (with excursion) by location, type of sample (EM AA/SP/CP vs. PM), count, date and time taken. Identify contaminating organism to allow for speculation of possible source; Review history of same organism in facility. Is there a trend? Ensure media is not contaminated and Growth Promotion Tests were acceptable. Ensure incubators within calibration. Ensure EM personnel were adequately trained. 20

21 Manufacturing Investigation Can be led by QA or performed by Production personnel. Details to be evaluated and documented for EM/PM excursions: Check Sanitization just prior to the event; proper use dilutions/approved disinfectants. Any unusual corrective interventions performed around that time? Was aseptic technique used? Check Training up to date for Mechanics/Operators; gown qualified Verify Pressure differentials. Verify Temperature/% Relative Humidity within limits Ensure no Non Viable particulate alarms Check filter maintenance/certification. Evaluate if any recent construction or equipment maintenance in area. Ask: Are other batches affected? 21

22 Contact Plates Static monitoring or taken after completion of filling Issues to evaluate and document: Disinfectant preparation dilutions, expiration date. Sanitization procedures for materials passing in to Aseptic Area and for disinfection of rooms. Disinfectant Efficacy Studies. Actions taken in the room during filling of batch (if after filling completion) Personnel Excursions: Type of organism is critical. Are people sanitizing their hands with alcohol sufficiently? May wish to retrain staff if they have repeated hits and 3 consecutive hits warrant disqualification until retrained in aseptic technique. Note that organisms pass through pores in gowns Need time limit in aseptic area, such as 2 3 hours. 22

23 Investigation Summary Root Cause Assessment based on all the facts provided by QC and Production; Can be done by QC or QA Evaluate people, material flow, training, sanitization, and etc. Determine most probable root cause. Risk and Impact Assessment Could the organism have contaminated a batch of product? Is the product aseptically filled or terminally sterilized? If the organism is Gram negative or a mold, is there concern for endotoxin or allergens, respectively? Determine Corrective Actions/Preventive Actions (CAPAs) (recommendations can be obtained from QC and Production). 23

24 Risk Assessment The severity of the risk is highest when product, containers, closures or product contact surfaces can be contaminated. Once the severity is established, this is considered in relation to the likelihood of occurrence and the ability to detect the occurrence. If these issues result in a high risk, it may lead to batch rejection, even if root cause cannot be determined. Controls that serve to reduce the likelihood of the occurrence or increase the ability to detect the occurrence are also considered as follow up action. High risk activities require corrective (remedial) actions. 24

25 CAPAs Corrective Action: Immediate actions taken after identification of root cause Preventive Actions: Prediction of problem and actions taken to avoid the occurrence through self initiated actions and analysis related to processes/products. CAPA Effectiveness should be checked by QA or Compliance 25

26 Batch Disposition QA Batch Disposition Acceptable for further processing or Reject? Be sure to evaluate all effected batches. 26

27 Conclusion People are the greatest source of contamination in an aseptic area so in designing/re designing a facility, keep that in mind and reduce the number of people to decrease EM and PM excursions. Isolators in production are very helpful or Restricted Area Barriers (RABs). Blow/Fill/Seal is another way to go. Whenever possible, use terminal sterilization. Any questions? 27

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