Media/Glasswares Required

Critical Points Sample Description Materials Required HPC YEAST AND MOLDS COLIFORM Final Reports
(PETRI DISH) (PETRI DISH) (CULTURE TUBES)
CP # 1 After UV Sterilizer (Out Flow Valve) Media Tube + Sterilized Swab 1 1 N/A DLCI-QA-43rev.00
CP # 2 Compunding Tank (Sampling Valve) Media Tube + Sterilized Swab 1 1 N/A
CP # 3 Filtration Machine (Out Flow Valve) Media Tube + Sterilized Swab 1 1 N/A
Pilot Line/ Line 0 Line 3 / Line 5
CP # 4 Filling Chamber Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 5 Big Hose Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 6 Big Hose Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 7 Small Hose Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 8 Small Hose Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 9 Nozzle Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 10 Nozzle Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 11 Nozzle Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 12 Nozzle Nozzle Media Tube + Sterilized Swab 1 1 N/A
CP # 13 Rinsed Bottle Clean Plastic Bag 1 1 N/A
CP # 14 Treated Caps Clean Plastic Bag 1 1 N/A
CP # 15 Final Product Sample Actual Product (W/ Batch Code) 2 1 + 1(PETRIFILM) 5
CP # 16 Deionized Water Sample Sterilized Bottle 1 1 5 AFBI-QA-12rev.02
CP # 17 Puree Sample (PMR only) Sterilized Bottle 1 1 5
TOTAL 18 17 15
35 PETRI DISH/PLATES 15 CULTURE TUBES

MEDIA COMPUTATION HPC SDA COLIFORM

For Every 6 Plates (100ml) 300-400ML 300-400ML 300ML
 ADAPTA PRODUCTION LINE - 5 GALLONS
Media/Glasswares Required
Pipettes
Critical Points Sample Description Materials Required HPC COLIFORM ALGAE Final Reports
10 mL 2 / 5 mL (PETRI DISH) (CULTURE TUBES) (PETRI DISH)
SP # 1 Source Water Sterilized Sampling Bottle 1 2 5 2
SP # 2 After Carbon Filtration Sterilized Sampling Bottle 1 2
SP # 3 After UV Sterilizer # 1 Sterilized Sampling Bottle 1 2 2
SP # 4 After 0.2 Micron Filter Sterilized Sampling Bottle 1 2 2
SP # 5 Filler Nozzle (1 or 2) Sterilized Sampling Bottle 1 2 5
SP # 6 Contact Tank Sterilized Sampling Bottle 1 2
SP # 7 Treated Caps Sterilized Sampling Beaker 1 2
SP # 8 Untreated Caps Sterilized Sampling Beaker 1 2
SP # 9 Rinsed Bottle 1 Peptone Water 1 1
SP # 10 Rinsed Bottle 2 Peptone Water 1 1
FP # 1 Final Product (Capped 5 Gallon Bottle) 1 2 5 2
FP # 2 - N Final Product (Capped 5 Gallon Bottle) n= # of samples, ave= 12 2 x 12 = 24pcs 5 x 12 = 60pcs
TOTAL 15 PCS 8 PCS 44 PCS 75 PCS 8 PCS
 # FLOW RESPONSIBILITY / REMINDERS NOTES
1 Sanitation of Compounding Area Observe GMP GMP
Swabbing for Compounding of Non Alcoholic ProduPrepare 3 Sterilized Swab Sticks + 3 Media Tubes + 1 Sterilized Bottle (DI Water Sample) Validation of Compounding Sanitation
2
Critical Sampling Points (CP #1-3) Usually performed the day before the actual Bottling/Production (EST: 0900H-1100H)
Analysis must not exceed 8 hours after sampling or samples should be stored in the Cooler/Refrigerator Sampling Procedure
First Day

3 Store Samples (CP#1-3, 16)
4 Sanitation of Production Line/Area
5 Submission/Testing of Final Filtration Sample
Swabbing for Production Area / Filling Machine Must be performed on the day of production.
6
Critical Sampling Points (CP #4-12)
Second Day
Remind Compounding Personnel of the DI Water Sample, Submitted usually after 2 hours from Swabbing of the first 3 Critical points
Accomplish Sampling Slip
Observe GMP Proper Gowning must tbe observed (Sterile Suit/ Rubber Boots)
Accomplish DLCI-QA-13rev.01 Sterilization of Bottling Equipment Checklist
Indication that production of non alcoholic product will proceed.
Coordinate with Chemist
Prepare 9 Sterilized Swab Sticks + 9 Media Tubes Validation of Production Sanitation
Critical Points vary between Production Lines (i.e. 'Uncontrolled Production Lines" samples from Filling Nozzles only)

Rinsing of the sampling points must be immediately performed after swabbing.

7 Start of Bottling Observe GMP
Collection of Rinsed Bottle, Treated Caps, FP Collection can be done on 0900H, 1300H, 1500H; dependent on the duration of bottling
8
Critical Sampling Points (CP #13-15) Ensure that FP is capped and with printed batch code
Must be performed on the same day of production (AFBI Laboratory) GLP
9 Analysis and Inoculation of Critical Points Materials that must be prepared beforehand (Plates and Pipettes)
Take note Start of Incubation (Clearance of final product will be dependent on this detail)
Determine if needed to proceed to Confirmatory Testing
10 Initial Reading of Incubated Samples
Relay results to QA Manager
Third Day

Proceed to accomplishment of DLCI-QA-12 Clearance for Release of Products 2 day clearance made possible with utilization of 3M Petrifilm
Final Reading of Final Product (CP# 15)
11 and DLCI-QA-26rev.02 Monitoring Sheet of Clearance for Bottling of Compounded Products (Standard incubation for Yeast & Molds is 5-7 days)
& HPC Plates + LB Culture Tubes
Target Objective for Clearance of Non Alcoholic Product is NMT Two (2) Days
12 Decontamination and Washing of HPC & Culture T Prepare for Next Sterilization GLP

Accomplish QA-DLCI-43 Microbiological Analysis Report - Two Copies (1) QA & (1) Lab/R&D/Compounding
Seventh Day

Prepare separate copies of non conformed results if needed

13 Final Reading of Yeast and Molds Plates Accomplsh AFBI-QA-08 Microbiological Analysis Report (DI Water) - Three Copies (1)QA, (1)AFBI, & 1(Lab/R&D/Compounding)
(CONFIDENTIAL)
Relay results to QA Manager
14 Decontamination and Washing of Y&M Plates Prepare for Next Testing
 # FLOW
1 Preparation of Glasswares, Materials, Media etc.
Day Before Production
Swabbing for Compounding of Non Alcoholic ProducPrepare 3 Sterilized Swab Sticks + 3 Media Tubes + 1 Sterilized Bottle (DI Water Sample)
2
Critical Sampling Points (CP #1-3)
3 Store Samples (CP#1-3, 16)
4 Sanitation of Production Line/Area
5 Submission/Testing of Final Filtration Sample
Swabbing for Production Area / Filling Machine Must be performed on the day of production.
6
Critical Sampling Points (CP #4-12)
Production Day
7 Start of Bottling
Collection of Rinsed Bottle, Treated Caps, FP
8
Critical Sampling Points (CP #13-15)
9 Analysis and Inoculation of Critical Points
Day After Production
Seventh Day (Initial Reading)
10 Initial Reading of Incubated Samples
Final Reading of Final Product (CP# 15)
11
& HPC Plates + LB Culture Tubes
12 Decontamination and Washing of HPC & Culture Tubes
13 Final Reading of Yeast and Molds Plates
14 Decontamination and Washing of Y&M Plates
RESPONSIBILITY / REMINDERS NOTES
Estimate Number of Final Product Samples (AVE: 10 BATCHES = 10 SAMPLES) + WATER CCP SAMPLES (10 SAMPLES)
Sampling Bottles 10 mL Pipettes 5 mL Pipettes Media Plates Culture Tubes Sampling Beakers
5 pcs FP (10pcs) + WCCP( 10pcs) 10 PCS 12 X 5 = 60PCS 2 GMP
Validation of Compounding Sanitation
Usually performed the day before the actual Bottling/Production (EST: 0900H-1100H)
Analysis must not exceed 8 hours after sampling or samples should be stored in the Cooler/Refrigerator Sampling Procedure
Remind Compounding Personnel of the DI Water Sample, Submitted usually after 2 hours from Swabbing of the first 3 Critical points
Accomplish Sampling Slip
Observe GMP Proper Gowning must tbe observed (Sterile Suit/ Rubber Boots)
Accomplish DLCI-QA-13rev.01 Sterilization of Bottling Equipment Checklist
Indication that production of non alcoholic product will proceed.
Coordinate with Chemist
Prepare 9 Sterilized Swab Sticks + 9 Media Tubes Validation of Production Sanitation
Critical Points vary between Production Lines (i.e. 'Uncontrolled Production Lines" samples from Filling Nozzles only)
Rinsing of the sampling points must be immediately performed after swabbing.
Observe GMP
Collection can be done on 0900H, 1300H, 1500H; dependent on the duration of bottling
Ensure that FP is capped and with printed batch code
Must be performed on the same day of production (AFBI Laboratory) GLP
Materials that must be prepared beforehand (Plates and Pipettes)
Take note Start of Incubation (Clearance of final product will be dependent on this detail)
Determine if needed to proceed to Confirmatory Testing
Relay results to QA Manager
2 day clearance made possible with utilization of 3M Petrifilm
(Standard incubation for Yeast & Molds is 5-7 days)
GLP
Prepare separate copies of non conformed results if needed
(CONFIDENTIAL)
 SYNCHROBLOC PRODUCTION LINE - 375 mL, 500 mL, 1L
Media/Glasswares Required
Pipettes
Critical Points Sample Description Materials Required HPC COLIFORM ALGAE** Final Reports
10 mL 2 / 5 mL (PETRI DISH) (CULTURE TUBES) (PETRI DISH)
SP # 1 Source Water Sterilized Sampling Bottle 1 2 5 2
SP # 2 After Carbon Filtration Sterilized Sampling Bottle 1 2
SP # 3 After UV Sterilizer # 1 Sterilized Sampling Bottle 1 2 2
SP # 4 After 0.2 Micron Filter Sterilized Sampling Bottle 1 2 2
SP # 5 After UV Sterilizer # 2 Sterilized Sampling Bottle 1 2
SP # 6 Contact Tank Sterilized Sampling Bottle 1 2 5
SP # 7 Unwashed Bottles (6pcs) Clean Plastic Bag / Peptone Water 1 6
SP # 8 Washed Bottles (6pcs) Clean Plastic Bag / Peptone Water 1 6
SP # 9 Rinsed Bottles (6pcs) Clean Plastic Bag / Peptone Water 1 6
SP # 10 Filling Nozzles (6pcs) Pepton Water / Swab Sticks 1 6
SP # 11 Untreated Caps Sterilized Sampling Beaker 1 2
SP # 12 Treated Caps Sterilized Sampling Beaker 1 2
N/A Contact Tank Rinser* Sterilized Sampling Bottle 1 2 5
N/A Reverse Osmosis Sample* Sterilized Sampling Bottle 1 2
N/A Storage Tank Sample* Sterilized Sampling Bottle 1 2
FP # 1 Final Product (Capped 5 Gallon Bottle) 1 2 5 2
FP # 2 - N Final Product (Capped 5 Gallon Bottle) n= # of samples, ave= 5 2 X 5 = 10PCS 5 x 4 = 60pcs
TOTAL 15 PCS 12 PCS 58 PCS 80 PCS 8 PCS

48
 # FLOW RESPONSIBILITY / REMINDERS NOTES
Complete Sanitation and Fumigation Preparation of Virucidal Solution 1g in 1000mL Distilled/Deionized Water

Sterilization of Filling Nozzles, Gasket c/o Line Tech; Attach autoclave tapes
Estimate Number of Final Product Samples (AVE: 5 BATCHES = 5 SAMPLES) + WATER CCP SAMPLES (16 SAMPLES)
Sampling Bottles 10 mL Pipettes 5 mL Pipettes Media Plates Culture Tubes Sampling Beakers
9 pcs FP (5pcs) + WCCP(4pcs) 12 PCS 16 X 5 = 80PCS 2 GMP
1 Preparation of Glasswares, Materials, Media etc.
Prepare 6 Sterilized Swab Sticks + 6 Swab Tubes (6 NOZZLES) + 18 Peptone Tubes (6 UNWASHED + 6 WASHED + 6 RINSED BOTTLES)
Day Before Production

Collection of Unwashed and Washed Bots
2
(SP # 7-8)
3 Testing of Washed and Unwashed
4 Sanitation of Production Line/Area
Swabbing for Production Area / Filling Machine;
Seventh Day (Initial Reading) Morning Production Day
Prepare for Plate Exposure: 1PCA & 1SDA for: Synchrobloc Filling Area, Caps Room, Air Intake, Filter House
Random Sampling Unwashed Bottles and Washed Bottles (PCA ONLY + 12 PLATES) Validation of Compounding Sanitation
Usually performed the day before the actual Bottling/Production (EST: 0900H-1100H)
Analysis must not exceed 8 hours after sampling or samples should be stored in the Cooler/Refrigerator Sampling Procedure
Prepare 250ml-300ml PCA for 12 Plates (6 Unwashed + 6 Washed Bottles)
Incubate for HPC Analysis
Observe Line Techinician and Production Worker during Sanitation Proper Gowning must tbe observed (Sterile Suit/ Rubber Boots)
Provide Sanitation Checklists (c/o Production Department)
Prepare 6 Sterilized Swab Sticks + 6 Media Tubes Validation of Production Sanitation

6 Collection of RInsed Bottles and Treated Caps Must be performed on the day of production. (EST: 0700H-0800H)
Critical Sampling Points (SP #9, 10, 12) Rinsing of the sampling points must be immediately performed after swabbing.

7 Colection of Untreated Caps, Reverse Osmosis Sa Observe GMP

Collection of Rinsed Bottle, Treated Caps, FP
8
Critical Sampling Points (CP #13-15)
9 Analysis and Inoculation of Critical Points
Day After Production
Collection can be done on 0900H, 1300H, 1500H; dependent on the duration of bottling
Ensure that FP is capped and with printed batch code
Must be performed on the same day of production (AFBI Laboratory) GLP
Materials that must be prepared beforehand (Plates and Pipettes)
Take note Start of Incubation (Clearance of final product will be dependent on this detail)

Determine if needed to proceed to Confirmatory Testing

10 Initial Reading of Incubated Samples
Relay results to QA Manager
2 day clearance made possible with utilization of 3M Petrifilm
Final Reading of Final Product (CP# 15)
11 (Standard incubation for Yeast & Molds is 5-7 days)
& HPC Plates + LB Culture Tubes

12 Decontamination and Washing of HPC & Culture Tubes GLP

Prepare separate copies of non conformed results if needed

13 Final Reading of Yeast and Molds Plates (CONFIDENTIAL)

14 Decontamination and Washing of Y&M Plates

PROCEDURES MANUAL
1 PM-DLCI-02-28Compounding and Filtration of Liquors, Alcoholic Beverages, and Juices
2 PM-DLCI-02-11Bottling of Final Product
3 PM-DLCI-03-07