D-125
Microbiological Method Suitability
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1.0 Purpose The purpose of this procedure is to determine method suitability for internal procedures D- 715.0 Microbial Limits Testing using Agar plates and D-715 Microbial Limits Testing using Neogen Petrifilm System. Method suitability, as stated in USP <2021>, USP <2022>, USP <61> and USP <62>, is the ability of organism to grow in the presence of product. If organisms do not grow or show < 50% recovery the final product is considered inhibitory at the dilution tested and will be further tested by additional dilutions or neutralizing diluent. If organisms show >200% recovery the final product is considered an enhancement product at the dilution tested and will be further tested by additional dilutions or neutralizing diluents 2.0 Seope This procedure applies to internal procedures D-715.0-Microbial Limits Testing using Agar plates, which includes enrichment and D-715-Microbial Limits Testing using Neogen Petrifilm System, 3.0 Responsibility 4.0 ou — It is the responsibility of QC Analysts to follow this procedure. it is the responsibility of QC Laboratory Management to implement this procedure and )no ab to ensure that the procedure is followed. )ea )ew it is the responsibility of QC Laboratory Management to keep current this procedure and to oversee validations. Definitions 4.1 Diluent — The sterile medium used to dissolve/suspend and dilute samples [SOP Standard Operating Procedure Rev Page 2 of 15 Microbiological Method Suitability 4.2 Inoculum — The prepared sample that is placed on the agar dish, petrifilm or Enhancement media via pipet YPA — Isopropy! Alcohol QC ~— Quality Control TAPC — Total Aerobic Plate Count 4.6 EN'EC — Too numerous to Count 4,7 MPN — Most probable number 4.8 NaOH — Sodium Hydroxide 4.9 HCl ~ Hydrochloric Acid 4.10 TSA — Tryp-Soy Agar All TSB — Tryp-Soy Broth SDA — Sabouraud Dextrose Agar ALD ~ Xylose, Lysine, Desoxycholate Agar dishes MSA — Mannitol Salt Agar Plates TSB w/L&T80 — Tryp-Soy Broth with Lecithin and Tween 80 AC — Aerobic Plate Count Plate EC ~&. coh / Coliform Count Plate iB ~ Enterobacteriaceae Count Plate STX — Staph Express Count Plate RYM — Rapid Yeast and Mold Count Plate [SOP Standard Operating Procedure SOP No | Rev | | | Microbiological Method Suitability D-125 | 4 | Pa3g ofe 15 | 3.0 References 5.1 USP <2021>Microbial Enumeration Tests-Nutritional and Dietary Supplement, 3.2 USP <2022> Microbiological Procedures for Absence of Specified Microorganisms- Nutritional and Dietary Supplements 5.3 USP <61> Microbiological Examination of Nonsterile products: Microbial Enumeration Tests. 5.4 USP <62> Microbiological Examination of Nonsterile products: Tests for Specified Microorganisms. 5.5 USP <1111>, Pharmacopeia Monograph, Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use 5.6 D-125-F 1, Form, Microbial Method Suitability Petrifilm Method 5.7 D-125-F2, Form, Microbial Method Suitability Agar Method 3.8 1-125-F3, Form, Microbial Method Suitability Specified Microorganism Method 3.9 D-125-F4, Form, Finished Product Microbiology Suitability Summary for Nutritional 5.10 D-824, SOP, Operation and Cleaning of the Tuttnauer EZ10 Autoclave 5.11 D-101, SOP, Laboratory Housekeeping 5.12 D-715, SOP, Microbial Limits Testing using Neogen Petrifilm System 5.13. D-715.0, SOP, Microbial Limits Testing using Agar Plates 5.14 D-L13, SOP, Microbiological Media Validation [SOP SOP No | Rev Standard Operating Procedure p-135 2 Page 4 of 1§ Microbiological Method Suitability 6.0 Required Supplies, Media and Equipment 6.1 Supplies 70% TPA Sterile and filtered IN HCI solution sterile and filtered IN NaOH solution 10m sterile serological pipettes 6.1.5 120mL sterile containers w/ Lid 6.1.6 200uL and ImL variable automatic pipettes w/ sterile tips 6.1.7 250mL, 500mL and 1L wide mouth storage bottles w/ screw cap top. 6.2 Media Tryp-Sey Broth Tryp-Soy Agar Rappaport-Versailles Media MacConkey Broth Mossel Enrichment Broth Sabouraud Dextrose Agar MacConkey Agar dishes Violet Red Bile Glucose Agar dishes Violet Red Bile Agar dishes 6.2.10 Cetrimide Agar dishes [SOP Standard Operating Procedure SOP No Rev Page § of 15 Microbiological Method Suitability D-125 6.2.11 Xylose, Lysine, Desoxycholate Agar dishes 6.2.12 Mannitol Salt Agar Plates 6.2.13 Tryp-Soy Broth with Lecithin and Tween 80 6.2.14 Butterfields Buffer 6.2.15 Peptone Salt Diluent 6.2.16 AC petrifilm 6.2.17 RYM petrifilm 6.2.18 EC Petrifilm 6.2.19 EB Petrifilm 6.2.20 STX Petrifilm 6.3 Equipment 6.3.1 Analytical Balance pH Meter Biological Safety Cabinet 6.3.4 Autoclave 6.3.5 25°C, 33°C, and 37°C Incubators Variable Temperature Circulating Water Bath Compound Microscope Darkfield Colony Counter [SOP SOP No | Rev Standard Operating Procedure D-133 » | Page 6 of 15 Microbiological Method Suitability 6.4 Organism 6.4.1 Candida albicans, ATCC 10231 6.4.2 Bacillus subtilis, ATCC 6633 6.4.3 Escherichia coli, ATCC 8739 6.4.4 Aspergillus brasilliensis, ATCC 16404 6.4.5 Pseudomonas paraeruginosa, ATCC 9027 6.4.6 Staphylococcus aureus, ATCC 6538 6.4.7 Salmonella enterica, ATCC 14028 7.0 Procedure 7.1 Media Preparation 7.1.1 Follow the preparation instruction on-line or on container for each media type and vendor Nete: Media may be purchased ready to use. 7.1.2 pH should be confirmed and / or adjusted before using. 7.1.3 Ensure that all media has been validated prior to testing (Refer to SOP D-113, Microbiological Media Validation). 72 Sample Labeling and Preparation 7.2.1 Sterilize all sample preparation equipment and media prior to use as per SOP D-824 Operation and Cleaning of the Tuttnauer EZ10 Autoclave. Single use, sterile disposables may also be used, 7.2.2 Label sample containers with a minimum of sample preparation # and Sample [SOP Micr S o t b a i n o d l a o r g d i c O a p l e r M a e t t in h g o P d r S o u c i e t d a u b r i e li ty | | S D O - P 2 S N : o | Re ; v | Page 7 of 15 Control or Sample + Bacteria testing. llaw oN DO Create a parent sample by transferring no less than 10g to the containers labeled in step 7.2.2 to either TSB or BPB. Alternatively, TSB w/L&T80 or Peptone Salt diluent may be used. 72.4 Before inoculation, sample pH should be adjusted with IN NaOH for acids products and IN HCI for alkaline products. If pH indicator strips are used 2 sample should be adjusted to pH 7.0. 7.3 Organism Preparation 7.3.1 Commercially prepared challenge organisms are suitable for use. 7.3.2 Prepare the challenge organisms per manufacturer instruction. Once ready, use the preparation immediately. The remaining suspension can be refrigerated and subsequently used for up to 8 hours. 7.4 Organism(s} to test for each method: Candida albicans x x Bacillus subtilis x x Escherichia coli . Xx x Aspergillus brasilliensis x x Pseudomonas aeruginosa | x staphylococcus aureus x x Salmonella enterica x 4 7.5 Agar Method Inoculation ~ TAPC and Yeast & Mold Count. 7.5.1 Sanitize the interior of the biological safety cabinet as per D-101 Laboratory Housekeeping before plating. 7.5.2 Obtain the required type of media and confirm they are not expired. 7.5.3 Prepare initial 1:10 of sample as per 7.2 section, using 90 mL. TSB as the diluent. [SOP S 7 t andard Op m e er r at a in t g i e ng Proc P e ro d c u ed r ur e e S 1 O 35 PN o | Re > v | Page 8 of | 15 Microbiological Method Suitability 7.5.4 Inoculate 1000 ul of diluent onte two plates and label as Negative Control. 7.5.5 Inoculate 1000 ul of initial 1:10 dilution onto two plates and label as Sample Control. 7.5.6 Inoculate two plates with the organism being tested (100ul of a 10-100 CFU/ml organism preparation) and label as Positive Control. 7.5.7 Tnoculate 1000 pl of initial 1:10 sample dilution onto two plates. Label plates as Sample + Challenge Organism. Add 100ul of the 10-100 CFU/ml organism preparation to each plate on top ofsample. 7.5.8 Pour TSA or SDA media into each of the plates. Candida albicans . x Bacillus subtilis x . Aspergillus brasilliensis _ . . x 7.5.9 Let cool and then incubate utilizing the table below: PSA . 30°C to 35°C . 24 hours-48 hours _ SDA 20°C to 25 °C | 3-5 Days _ 7.5.10 Repeat for each organism to be tested. 7.5.11 After incubation period, visually count colonies to determine the total raw count for the plate or if the colonies are difficult to see visually, use the Darkfield Colony Counter to determine the raw count. 7.5.12 Calculate the percent recovery as follows: avg. of sample + organism Percent Recovery = X& 100 avg. of organism contro} plate [SOP S s t an a d n a d rd a rd Oper ( a ne t ra i ti n n g Pro a cedu r “ e a | " 7 S . O 1 P 0 N 8 o | Re » v | Page 9 of 7 15 Microbiological Method Suitability | 75.12.) Document resulis on Logbook D-125-F2 Microbial Method Suitability Agar Methed. 7.5.13 The Percent recovery between the test plates and control plates must be 50- 200% for the method to be considered suitable for use, refer to section 8.0. 7.5.14 Wa TNTC result or a recovery greater than 200% is obtained, serial dilution and retest may be required. [f organisms do not grow or show < 50% recovery, proceed to section 9.0. 7.6 Petrifilo: Method 7.6.1 Sanitize the interior of the biological safety cabinet as per D-101 Laboratory Housekeeping before plating. 7.6.2 Obtain the required Petrifilm media and confirm they are not expired. 7.6.3 Prepare the initial sample dilution at 1:10 ratio with approximately 10g of sample and 90mL Buffered Phosphate Buffer or Peptone Salt as the diluent. If specific sample requires a 1g of sample, prepare 1:100 ratio using 99mL Batfered Phosphate Buffer or Peptone Salt as the diluent, 7.04 Before inoculation, sample pH should be adjusted to neutral level with IN NaOH tor acidic products, and IN HCl for alkaline products. [f pH indicator strips are used, sample should be adjusted to pH 7.0. 7.6.5 Inoculate petrifilm with 1000 ul of initial dilution sample in duplicate and label as Sample Control. Refer to D-715 Microbial Limits Testing using Neogen Peirifilm System for plating details. 7.6.6 tnoculate petrifiim with 1000 4 of diluent in duplicate and label as Negative Control. 7.6.7 Prepare 1000 ul of diluent containing 10-100 CFU of challenge organism (100ul of a 10-100 CFU/ml organism preparation), per film to inoculate. Ineculate in [SOP Standard Operating Procedure SOP No | Rey | | D-125 4 | Page 10 of 18 Microbiological Method Suitability duplicate, 1000 pl of preparation containing the organism being tested. Label as Positive Control. Prepare 1000 ul of initial sample dilution containing 100u!l of the 10-100 CFU/ml organism preparation, per film to inoculate. Inoculate in duplicate, 1000 ul of preparation containing the organism being tested. Label as Sample + Organism tested. 7.6.9 Organism(s) to test for each petrifilm: Candida albicans Bacillus subtilis . xX Escherichia coli . x Aspergillus brasiliensis x Staphylococcus aureus _ . Xx Salmonella enterica _ 7 x 7.6.10 Tncubate petrifilm utilizing the table below: AC 30°C to 35°C 24-48 hours RYM 20°C. to 25°C | 3-5 days EC 30°C to 35°C ; 24-48 hours EB 30°tCo 35°C 24-48 hours — SUX 30°C to 35°C . 24-48 hours 7.6.11 Repeat for each of the organisms to be tested. 7.6.12 Count plates and then calculate Percent Recovery: avg. of sample + organism Percent Recovery = —-— Xx 100 avg. of organism control] plate [SOP SOP No | Rey Standard Operating Procedure D-135 5 | Pageli of 15 Microbiological Method Suitability 7.6.12.1 Document results on Logbook D-125-F1 Microbial Method Suitability Petrifilm Method. 7.6.13 The Percent recovery between the test plates and control plates must be 50- 200% for the method to be considered suitable for use, refer to section 8.0. 7.6.14 Ifa TNTC result or a recovery greater than 200% is obtained, serial dilution and retest may be required. If organisms do not grow or show < 50% recovery, proceed to section 9.0. 7.7 Specified Microorganism Method 7.74 Sanitize the interior of the biological safety cabinet as per D-101 Laboratory Housekeeping before plating. Obtain the required media and confirm they are not expired. Inoculate plate with 1000 yl of initial 1:10 sample dilution in duplicate and label as Sample Control. LTA Inoculate plate with 1000 wl of diluent in duplicate and label as Negative Control. Using TSB as the initial diluent, prepare 1:10 sample dilution as per 7.2 section. 7716 Bile Tolerant Gram-Negative Bacteria/ Enterobacteriaceae Count — MPN Method o éi F7.6.1 Inoculate 10 ml of (1:10) sample dilution prepared, with 100 ul of Salmonella enterica. Mix and incubate at 20° to 24° for 2-5 hours. 7.7.6.2 After incubation, transfer ImL of the above dilution to 9mI. of Enterobacteria Enrichment Broth Mossel, incubate at 30°C to 35°C for 24 to 48 hours. ~ ~~ No ot Subculture on Violet Red Bile Glucose Agar and incubate for an additional 18 to 24 hours at 30°C to 35°C, [SOP Standard Operating Procedure — | | SOP ae ; Rev Pane 10 of 15 | Microbiological Method Suitability (D-15 2 ceil oris 7.7.6.4 Growth of colonies with a purple zone around them is indicative of Enterohacteria. 7.7.6.5 The method is suitaole if typical grow is observed at 0.1g/ml of sample solution. 7.7.7 Coliforms Count - MPN Method 7VA71 Inoculate 10 mi of 1:10 sample dilution prepared, with 100 pl Escherichia coli, Mix and incubate at 20° to 25° for 2-5 hours. 7.7.7.2 After incubation, transfer ImL of the above dilution to 9mL of Enterobacteria Enrichment Broth Mossel, incubate at 30°C to 35°C for 24 to 48 hours. 7.7.7.3 Subculture on Violet Red Bile Agar and incubate for an additional 18 to 24 hours at 30°C to 35°C. 7.7.7.4 Growth of lactose fermenting colonies (pink colonies) indicates the presence of coliforms. 7.7.7.5 The method is suitable if typical grow is observed at 0.1 g/ml of sample solution. 7.7.8 Escherichia coli 7.7.81 Inoculate (1:10) sample dilution prepared with 100 ul of Escherichia coli. Mix and incubate at 30°C to 35°C for 18 to 96 hours. After incubation, transfer ImL of the above dilution broth to 9 mL of MacConkey Broth, incubate at 42°C to 44°C in water bath for 18 to 24 ds ~ oa )~~ hours. 7.7.8.3 Subculture on MacConkey Agar at 30°C to 35°C for 18 to 72 hours. 7.7.8.4 Growth of lactose fermenting colonies (pink colonics) indicates the presence of Escherichia coli. [SOP Standard Operating Procedure SOP No Rev Mierobiological Method Suitability D-T25 daerB | Page 13 of 15 7.7.9 Salmonella 7.7.9.1 Inoculate (1:10) sample dilution prepared with 100 ul of Salmonella enterica. Mix and incubate at 30°C to 35°C for 18 to 24 hours. 7.7.9.2 After incubation, transfer lmL of the above dilution broth to 9 mL of Rappaport Vassiliadis Salmonelia Enrichment Broth incubate at 30°C to 345°C for 18 to 24 hours. 7.7.9.3 Subculture on XLD Agar at 30°C to 34°C for 18 to 72 hours. 7.7.9.4 Growth of well-developed, red colonies, with or without black centers is indicative of Salmonella. 7.7.10 Pseudomonas aeruginosa 7.7.40.1 Inoculate (1:10) sample dilution prepared with 100 pl of Pseudomonas aeruginosa. Mix and incubate at 30°C to 34°C for 18 to 24 hours. 7.7.10.2 Subculture on Cetrimide Agar at 30°C to 35°C for 18 to 72 hours. 7.710.3 Growth of yellow-green or blue-green colonies indicative of Pseudomonas aeruginosa. TIAL Staphylococcus aureus 7TAVA Inoculate (1:10) sample dilution prepared with 100 ul of Staphylococcus aureus, Mix and incubate at 30°C to 35°C for 18 to 24 hours. 7.7.11.2 Subculture on MSA agar at 30°C to 35°C for 18 to 72 hours. 7.7.11,.3 Growth of yellow or white colonies surrounded by a yellow zone is indicative of Staphylococcus aureus. 7.7.12 Interpretation and reporting results [SOP S S t t a a n n d d a a r r d d O O p n e er r a a ti t n i g ng Pro Pr c a e c d ed u u r r e e S D1 O 0 P 8 No | Re > v | Page 14 a of 15 Microbiological Method Suitability 7.7,12.1 Growth of the dicated organism on both the organism control plates and the sample + organism plates is a valid result for this method. There is no percent recovery calculated as these tests are used for absence or presence of specified organism only. 7.7.12.2 Document results on Logbook D-125-F3, Microbial Method Suitability Specified Microorganism Method. 7.712,3 Ino growth proceed to step 9.0 for neutralization methods. 8.0 Specifications 8.1 The Agar method or Petrifilm method Percent Recovery must be > 50% for all organisms to be considered a valid method. 82 The Specitied Organism method requires growth on both the sample + organism plate and the organism control plate to be considered a valid method . 8.3 If organisms do not grow or show < 50% recovery the product is considered inhibitory at the dilution tested and will be further tested by additional dilutions or neutralizing diluent. If organisms show >200% recovery the final product is considered an enhancement product at the dilution tested and will be further tested by additional dilutions or neutralizing diluents. 9.0 Neutralization / Removal of Antimicrobial Activity 9.1 Refer to USP <61>, USP <2021>Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests for common neutralizing agents/methods for interfering substances. The three most common techniques are: 9.1.1 Diluting the sample. 9.1.2 Incorporating neutralizing agents into the test specimen. 9.1.3 Performing membrane filtration of the samples to remove antimicrobial agents. [SOP Standard Operating Procedure — SOP No | Rev | Pave 15 of 15 | Microbiological Method Suitability | D-125 | 2 | Page k an 10.0 Reporting 10.1.1 Record the testing information and results on the logbook forms indicated in this protocol. 10.1.2 Upon completion of the study, prepare a summary report with the results of the microbiological suitability tests and the conclusions using form D-125-F4. IL Revision History Revision | Date | Description of Changes | . CCR # By 0 04/14/22 | New procedure. - . N/A G, Shaw _ j 09/30/22 | Made directions more clear to actual process. a CC-22-0395 G. Shaw | Updated Procedure and Forms to reflect current practices. Addition | | 2 Oa a n m e a 4/ n 2 e 8 | N O e f g e a n t u i m v e e r a Ba t c i t o e n r i m a e . t A h d o d d i s t i f o o n r C o o f l r i e f p o o r r m t s i n a g n s d e c B t i i l o e n T a o n l d e r F a o nt r m G r D a - m 1 - 2 5-F4 CC a -2 e 5- 001 An 8 A A . D P . erez Finished Product Microbiology Suitability Summary. [SOP ss| C O N F I D E N T I A L : s u b t i l i s B a c i l l u b r a s i l l i e n s i s A s p e r s i l i u h o d A g a r f o r S u i t a b i l i t y e n t e r i c a S a l m o n e l l a a u r e u s S t a p l e y l o c o c c u s . c o l i f s c h e r i c h i a . n U s e d / L o t D i l u e n t N u m b e r : L o g b o o k a l b i c a n s C a n d i d a b a p e . e d i a A C. a “Ti B y / D a t e : R e v i e w e d i p e t t e u l 1 0 0 0 o n P r o d u c t F i n i s h e d b s f o n H B I F o r D o n e ) : ( c i r c l e M e t n o D a t e # / E x p i r a t i o O t h e r : d a t e : L o t # / E x p M D a t e : D u e 4 / C a l P 2 5 - F F o r m : # N a m i e / F o r m u l a t i aE:1 LVP I D s e R O || uP P|. y lA n: on: i od u tP l i D ( | E n d : E n d : |) A v g ! 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D a t e : L o t W / E x p M e d i a B r o t h M A C R e v i e w e d D a t e : L o t t # / E x p M e d i a A g a r C e t r i m i d e 3 F o r m : F o r m u l a d : / N a m e P r o d u c t F i n i s h e d D a t e : # / E x p i r a t i o n U s e d / L o t D i l u e n t a F L 5 - s e E D - 1 2 uVD vO iR nP eP Aa : n o i l i l u t b i a D o ( r |c i M B n d : r ) E n d : E n d : E n d : E n d : S t a r t E n d : S t a r t : S t a r t I n : o . S t a r t e t h o d oNM : |Ry R E J E C T E D 1 0 0 a r L D | C o m m e n t s : 5 - 0 0 1 8 C C t h E E s — S u i t a b i l i t r a t ( t e s t t / C a l u l e d i a A g C C - 2 d i a @ r o f o r T e s t t i o n a n o t h e u e P i p e t t e o t # / E x p M o w / E x p M e S p e c i f i e d a n o t h e r u s e o r d i l u e : L o g b o o k D a t e : D D a t e : L i o n : D a t e : L O M i c r o o r g a n i a m s mgs o r P a e v i fR f o )2 t n l u e o f i d e g a P 1 f o | SSN [SOP Finished Produet Microbiology Suitability Summary Form: D-125.F4 CCR No: CC-25-0018 Revision: 6 Method Sutta bility Information Sample Weight Dilation Diluent Logbook reference Conclusion(s): Initiated By: Approved By: