## ASEPTIC PROCESSING & PACKAGING REPORT

**(FDA FORM 3511-3)**

**This inspection report (Form 3511-3) is available for downloading from
the following forms sites:**

<http://www.fda.gov/opacom/morechoices/fdaforms/ora.html>. **The form is
an MS Word document that can be expanded or contracted like any Word
document. Under "Container Sterilizing, Filling & Closing Operations",
delete sections pertaining to container sterilizing, filling/closing
systems not covered during the inspection. This instruction paragraph
can also be deleted from the finished report. Copy and paste this report
intoTurbo EIR under the heading "Aseptic Processing & Packaging
Report".**

**References: Guide to Inspection of Aseptic Processing and Packaging
For the Food Industry, Feb, 2001;**

**21CFR Parts 113.40(g) and 108.35**

[ESTABLISHMENT REGISTRATION - 108.35(c)(1)]{.underline}

-   HAS THE FIRM REGISTERED THEIR PROCESSING ESTABLISHMENT WITH FDA? YES
    \[ \] NO \[ \]

> IF FIRM HAS REGISTERED, THE FCE NO. IS
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_.

######## [PROCESS ESTABLISHMENT & FILING -- 108.35(c)(2), 113.83]{.underline}

-   HAVE SCHEDULED PROCESSES BEEN FILED WITH FDA LISTING ALL CRITICAL
    FACTORS NECESSARY TO ACHIEVE COMMERCIAL STERILITY FOR THE PRODUCT,
    THE PRODUCT STERILIZATION SYSTEM, THE PACKAGING STERILIZATION SYSTEM
    AND THE PACKAGING MATERIAL? YES \[ \] NO \[ \]

-   HAVE SCHEDULED PROCESSES USED BY THE FIRM BEEN RECOMMENDED BY A
    PROCESS AUTHORITY (LETTER, BULLETIN, SOP MANUAL, ETC.)? YES \[ \] NO
    \[ \]

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-   DOES THE FIRM HAVE A PROCESS LETTER OR OTHER DOCUMENTATION LISTING
    CRITICAL FACTORS NECESSARY TO CONTROL IN THE ATTAINMENT OF
    COMMERCIAL STERILITY? YES \[ \] NO \[ \]

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-   ARE FILED PROCESSES AT LEAST EQUAL TO RECOMMENDED PROCESSES PROVIDED
    BY THE PROCESS AUTHORITY? YES \[ \] NO \[ \]

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-   DOES THE FIRM HAVE ON FILE SUPPLEMENTAL INFORMATION LISTING
    PROCEDURES FOR PRE-STERILIZATION AND STERILITY MAINTENANCE OF
    PROCESSING AND PACKAGING EQUIPMENT AND STERILIZATION OF PACKAGING
    MATERIAL? YES \[ \] NO \[ \]

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-   HAVE FILED, SCHEDULED PROCESSES BEEN CHANGED IN SUCH A WAY THAT
    COULD AFFECT THE ATTAINMENT OF COMMERCIAL STERILITY? YES \[ \] NO \[
    \]

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-   IF PROCESS CHANGES HAVE BEEN MADE THAT COULD AFFECT THE ATTAINMENT
    OF COMMERCIAL STERILITY, HAVE THE CHANGES BEEN REVIEWED AND
    SUBSTANTIATED BY A QUALIFIED SCIENTIFIC AUTHORITY AND FILED WITH
    FDA? YES \[ \] NO \[ \]

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-   LIST THE FIRM'S PROCESS AUTHORITIES:

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-   ARE PROCESS AUTHORITIES THE SAME AS THOSE FILED WITH FDA? YES \[ \]
    NO \[ \]

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-   LIST ALL PRODUCTS COVERED DURING THIS INSPECTION:

> [PRODUCT]{.underline} [STYLE OF PACK]{.underline} [CONTAINER
> TYPE/SIZE]{.underline}

-   LIST ALL FACTORS CRITICAL TO THE ATTAINMENT AND MAINTENANCE OF
    COMMERCIAL STERILITY PER PROCESS AUTHORITY LETTER AND FDA FILING
    FORMS FOR PRODUCTS COVERED DURING THIS INSPECTION (INCLUDE
    PRESTERILIZATION AND MAINTENANCE OF STERILITY IN THE ASEPTIC
    PROCESSING AND PACKAGING SYSTEMS AND SURGE TANKS AS WELL AS THE
    PROCESSING, PACKAGING AND HOLDING OF PRODUCTS IN THESE SYSTEMS) --

[RAW MATERIALS]{.underline}

-   DOES THE FIRM TAKE ADEQUATE MEASURES TO PREVENT THE BUILD-UP OF
    MICROORGANISMS IN UNPROCESSED PRODUCT BEFORE THERMAL PROCESSING? YES
    \[ \] NO \[ \]

-   WHAT IS THE SOURCE OF WATER USED FOR PROCESSING AND CLEAN UP IN THE
    PLANT?

-   IS PLANT WATER ADEQUATELY TREATED WITH CHLORINE OR OTHER APPROVED
    CHEMICALS TO RENDER IT POTABLE? YES \[ \] NO \[ \]

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-   ARE ALL FOOD AND COLOR ADDITIVES FDA APPROVED? YES \[ \] NO \[ \]

[PRODUCT PREPARATION - 113.81]{.underline}

-   ARE PRODUCTS PREPARED ACCORDING TO THE METHOD AND/OR FORMULATION
    SPECIFIED IN THE RECOMMENDED SCHEDULED PROCESS? YES \[ \] NO \[ \]

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-   ARE INGREDIENTS WEIGHED PROPERLY USING ACCURATE SCALES: YES \[ \] NO
    \[ \]

### [PRODUCT STERILIZATION EQUIPMENT AND CONTROLS]{.underline}

### 

###  TEMPERATURE INDICATING DEVICE -- 113.40(g)(1)(i)(a): 

-   IS THE PRODUCT STERILIZER EQUIPPED WITH AT LEAST 1 MERCURY-IN-GLASS
    THERMOMETER OR EQUIVALENT TEMPERATURE-INDICATING DEVICE (TID) THAT
    COMPLIES WITH PART 113.40(g)(1)(i)(a)? YES \[ \] NO \[ \]

-   IS THE TID CHECKED FOR ACCURACY AT LEAST ONCE PER YEAR & DOCUMENTED
    PER PART 113.40(g)(1)(i)(a)? YES \[ \] NO \[ \]

### TEMPERATURE RECORDING DEVICE -- 113.40(g)(1)(i)(b):

-   IS THE PRODUCT STERILIZER EQUIPPED WITH A TEMPERATURE RECORDING
    DEVICE INSTALLED IN THE PRODUCT FLOW AT THE HOLDING-TUBE OUTLET
    BETWEEN THE HOLDING TUBE AND THE INLET TO THE COOLER? YES \[ \] NO
    \[ \]

-   IS THE TEMPERATURE RECORDING DEVICE ADJUSTED TO AGREE AS NEARLY AS
    POSSIBLE WITH BUT NEVER HIGHER THAN A KNOWN ACCURATE
    MERCURY-IN-GLASS THERMOMETER? YES \[ \] NO \[ \]

-   DOES THE TEMPERATURE RECORDING DEVICE COMPLY WITH ALL REQUIREMENTS
    OF 113.40(g) (1)(i)(b)? YES \[ \] NO \[ \]

### TEMPERATURE RECORDER CONTROLLER (TRC) - 113.40(g)(1)(i)(c))

-   IS THE TRC INSTALLED IN THE PRODUCT STERILIZER AT THE FINAL HEATER
    OUTLET? YES \[ \] NO \[ \]

-   DOES THE TRC MEET THE REQUIREMENTS OF 113.40(g)(1)(i)(c)? YES \[ \]
    NO \[ \]

-   DESCRIBE HOW THE TEMPERATURE RECORDER DEVICE IS CHECKED FOR ACCURACY
    --

METERING (TIMING) PUMP - 113.40 (g) (1) (i) (f):

-   DESCRIBE THE TYPE OF METERING PUMP --

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-   IS THE PUMP LOCATED UPSTREAM FROM THE HOLD TUBE? YES \[ \] NO \[ \]

-   THE PUMP IS A FIXED RATE \[ \], OR VARIABLE SPEED \[ \]

-   IS THERE A MEANS OF PREVENTING UNAUTHORIZED SPEED CHANGES?

YES \[ \] NO \[ \]

-   IF YES, WHAT ARE THE MEANS FOR PREVENTING UNAUTHORIZED SPEED
    CHANGES?

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-   IF THE PUMP IS OTHER THAN A POSITIVE DISPLACEMENT TYPE, WHAT
    EVIDENCE DOES THE FIRM HAVE THAT IT IS CAPABLE OF MAINTAINING THE
    REQUIRED RATE OF PRODUCT FLOW?

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-   DOES THE FIRM USE A FLOW METER TO RECORD OR REGULATE PRODUCT FLOW?

YES \[ \] NO \[ \]

-   IF A FLOW METER IS USED, LIST THE FLOW METER MAKE AND MODEL NO. AND
    EXPLAIN HOW IT IS USED.

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-   WHAT PROCEDURES ARE USED TO VALIDATE THE FLOW RATE? (PUMP STROKES,
    CONTAINERS OR GAL/TIME PERIOD, TACHOMETER, ETC) -

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-   HAS THE PROCESSOR DOCUMENTED THAT THE FLOW RATE AND FLOW

> CHARACTERISTICS OF THE PRODUCT ARE THE SAME AS THOSE ESTABLISHED BY
> THE

PROCESS AUTHORITY? YES \[ \] NO \[ \]

-   IS THE PRODUCT FLOW RATE MONITORED AND DOCUMENTED BY THE PROCESSOR
    AS A ROUTINE PART OF THE SYSTEM OPERATION? YES \[ \] NO \[ \]

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-   HOW IS THE FLOW METER SYSTEM MAINTAINED[?]{.underline}

# PRODUCT HEATER:

> IS THE PRODUCT HEATING SYSTEM: STEAM INJECTION \[ \]; STEAM INFUSION
> \[ \]; PLATE HEAT \[ \]; TUBULAR \[ \], OR SCRAPPED SURFACE \[ \] HEAT
> EXCHANGER; OHMIC \[ \]; OTHER \[ \] EXPLAIN --

# PRODUCT TO PRODUCT REGENERATOR (113.40(g)(1)(i)(d)):

-   IF A PRODUCT TO PRODUCT REGENERATOR IS USED, IS IT EQUIPPED WITH A
    PRESSURE DIFFERENTIAL RECORDER CONTROLLER TO ASSURE THAT THE
    PRESSURE OF THE STERILIZED PRODUCT IN THE REGENTERATOR IS GREATER
    THAN THE PRESSURE OF ANY UNSTERILIZED PRODUCT IN THE REGENERATOR?
    YES \[ \] NO \[ \] REGENERATOR NOT USED \[ \]

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-   IF YES, DOES THE DIFFERENTIAL PRESSURE RECORDER CONTROLLER COMPLY
    WITH Part 113.40(g)(1)(i)(e)? YES \[ \] NO \[ \]

YES \[ \] NO \[ \]

-   HAS THE PRESSURE DIFFERENTIAL RECORDER BEEN TESTED FOR ACCURACY?
    113.40(g)(1)(I)(e)

YES \[ \] NO \[ \] N/A \[ \]

-   IF SO, LIST THE TEST DATE --

# STERILIZER (PRODUCT HOLDING TUBE) (113.40(g)(1)(i)(g):

-   IS IT SLOPED UPWARD AT LEAST 0.25 IN./FT? YES \[ \] NO \[ \]

-   IF DISASSEMBLED FOR CLEANING, HOW DOES THE FIRM ASSURE AFTER
    REASSEMBLY THAT IT CONFORMS TO THE SCHEDULED PROCESS PARAMETERS?

-   DOES THE DIAMETER AND LENGTH CONFORM TO THAT LISTED IN THE FILED
    SCHEDULED PROCESS? YES \[ \] NO \[ \]

-   IS IT DESIGNED SO THAT NO PORTION OF TUBE CAN BE HEATED BETWEEN
    PRODUCT INLET & OUTLET?

YES \[ \] NO \[ \]

######## [EQUIPMENT DOWNSTREAM FROM THE HOLDING TUBE]{.underline}

# FLOW DIVERSION SYSTEM (113.40(g)(1)(i)(h):

-   IS THE ASEPTIC PROCESSING SYSTEM EQUIPPED WITH A FLOW DIVERSION
    VALVE?

YES \[ \] NO \[ \]

-   IF PRESENT, IS IT INSTALLED IN THE PRODUCT PIPING LOCATED BETWEEN
    THE PRODUCT COOLER AND THE PRODUCT FILLER OR ASEPTIC SURGE TANK?

YES \[ \] NO \[ \]

-   IS IT DESIGNED TO AUTOMATICALLY DIVERT FLOW AWAY FROM THE FILLER OR
    ASEPTIC SURGE TANK? YES \[ \] NO \[ \]

-   IS IT DESIGNED/INSTALLED WITH NECESSARY SENSORS & ACTUATORS TO
    OPERATE WHENEVER THE STERILIZING TEMPERATURE IN THE HOLD TUBE OR
    PRESSURE DIFFERENTIAL IN THE PRODUCT REGENERATOR DROPS BELOW
    SPECIFIED LIMITS? YES \[ \] NO \[ \]

-   IS IT DESIGNED/OPERATED IN ACCORDANCE WITH RECOMMENDATIONS OF AN
    ASEPTIC PROCESSING & PACKAGING AUTHORITY? YES \[ \] NO \[ \]

-   DESCRIBE THE FIRM'S METHOD FOR DIVERTING NON-STERILE PRODUCT AWAY
    FROM THE FILLER OR ASEPTIC SURGE TANK INCLUDING ANY DOCUMENTATION
    FROM A PROCESSING AUTHORITY THAT MAY LIST SPECIFIC RECOMMENDATIONS
    FOR THE DESIGN AND OPERATION OF THE SYSTEM --

# DESCRIBE HOW FLOW DIVERSION INCIDENTS ARE DOCUMENTED INCLUDING CORRECTIVE ACTION AND DISPOSITION OF DIVERTED PRODUCT --

# STEAM SEALS (113.40(g)(1)(i)(*i):*

-   ARE ROTATING OR RECIPROCATING SHAFTS AND VALVE STEMS EQUIPPED WITH
    STEAM SEALS OR OTHER EFFECTIVE BARRIERS AT POTENTIAL ACCESS POINTS?
    YES \[ \] NO \[ \]

-   DOES THE FIRM MAINTAIN A RECORD SHOWING OBSERVATION OF THE STEAM
    SEALS FOR PROPER OPERATION? YES \[ \] NO \[ \]

# ASEPTIC SURGE TANKS 108.35(c)(2); 113.40(g)(1)(ii):

-   DOES THE FIRM HAVE DOCUMENTATION FROM THEIR PROCESS AUTHORITY
    SPECIFYING THE STERILIZATION PROCEDURE? YES \[ \] NO \[ \]

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-   ARE THEY ADEQUATELY VENTED OR PURGED OF AIR PRIOR TO STERILIZATION?

YES \[ \] NO \[ \]

-   ARE THEY STERILIZED WITH STEAM \[ \] OR HOT WATER \[ \] ?

-   HAVE VENT/PURGE AND STERILIZATION PROCEDURES & SCHEDULES BEEN
    ESTABLISHED BY A PROCESS AUTHORITY? YES \[ \] NO \[ \]

-   IS STERILE AIR OVER-PRESSURE MAINTAINED ON ASEPTIC SURGE TANKS?

YES \[ \] NO \[ \]

-   IS STERILE AIR PRODUCED BY: INCINERATION \[ \], FILTRATION \[ \],
    OTHER \[ \] -- EXPLAIN

-   HOW DOES THE FIRM MONITOR STERILE AIR OR GAS OVER-PRESSURE AND THEIR
    METHOD OF ACHIEVING STERILITY?

-   WHAT TYPE OF FILTER SYSTEM IS USED TO STERILIZE THE AIR - HEPPA
    (BOX) \[ \], CARTRIDGE \[ \], STERILIZING (CAPABLE OF BEING
    STERILIZED) \[ \] OR NON-STERILIZING \[ \] (***for example, the box
    filter is generally sterilized with a chemical or dry heat -- steam
    or hot water potentially will affect its integrity and should be
    avoided; cartridge filters are desigened to be used either for
    liquids or air and can be sterilized many different ways but moist
    heat and steam are perferred)***

-   IF A STERILE FILTER IS USED, WHAT ARE THE FILTER SPECIFICATIONS?

-   DOES THE FIRM HAVE EVIDENCE THAT WATER WILL OR WILL NOT EFFECT THE
    AIR FILTERATION PERFORMANCE OF THE FILTER? YES \[ \] NO \[ \]

-   HOW OFTEN ARE FILTERS CHANGED?

-   IS THIS FREQUENCY CONSISTENT WITH THE MANUFACTURER OR PROCESS
    AUTHORITY RECOMMENDATIONS? YES \[ \] NO \[ \]

-   ARE ASEPTIC FILTER CHANGES DOCUMENTED ON PROCESSING RECORDS?

YES \[ \] NO \[ \]

-   HAS THE PROCESS AUTHORITY, THE FILTER MANUFACTURER OR THE FIRM TOOK
    INTO ACCOUNT THE AFFECT OF INCINERATED AIR OR STEAM ON THE INTEGRITY
    OF FILTERS? YES \[ \] NO \[ \]

-   DOES THE FIRM HAVE A PROCEDURE FOR DETERMINING THE INTEGRITY OF
    FILTERS?

YES \[ \] NO \[ \]

-   IF YES, WHAT IS THE PROCEDURE AND IS IT CONSISTENT WITH THE
    PROCEDURES RECOMMENDED BY THE FILTER SUPPLIER AND/OR PROCESS
    AUTHORITY?

-   WHAT IS THE FIRM'S PROCEDURE FOR ENSURING THE STERILITY OF
    OVER-PRESSURE GASES AND ANY FILTERS USED TO FILTER THE STERILE
    GASSES ?

-   DO RECORDS INDICATE LOSS OF STERILITY IN THE SURGE TANK
    113.40 (g) (1) (ii) (d) YES \[ \] NO \[ \]

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-   IF YES, WAS THE INCIDENT RECORDED AN HANDLED AS A PROCESS DEVIATION
    113.40 (g) (1) (ii) (d) YES \[ \] NO \[ \]

# [PROCESS CONTROL SYSTEMS]{.underline}

-   ARE PRODUCT HEATING AND STERILIZATION SYSTEMS CONTROLLED MANUALLY \[
    \] OR BY COMPUTER \[ \] ?

-   WERE COMPUTERIZED CONTROL SYSTEMS VALIDATED UPON INSTALLATION TO
    INSURE THAT THEY OPERATE AS DESIGNED? YES \[ \] NO \[ \]

-   ARE AUTOMATED SYSTEMS ROUTINELY CHALLENGED/CALIBRATED TO VERIFY THAT
    PRODUCTS RECEIVE THE SCHEDULED PROCESS? YES \[ \] NO \[ \] IF YES,
    WHEN WAS THE LAST CALIBRATION PERFORMED ?
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> OBTAIN AS AN EXHIBIT A COPY OF THE MOST RECENT CHALLENGE/CALIBRATION
> RECORD FOR THE AUTOMATIC CONTROLS (INCLUDED SHOULD BE THE METHODOLOGY
> EMPLOYED, THE TESTING FREQUENCY, INDIVIDUALS WHO CONDUCTED THE TEST
> AND THE TEST RESULTS).

-   DOES THE FIRM HAVE DOCUMENTATION SHOWING THE VALIDATION OF
    STERILIZATION PROCEDURES YES \[ \] NO \[ \]

#  [ASEPTIC PROCESSING RECORDS 113.40 (g) (1) (ii) (e)]{.underline}

ARE RECORDS MAINTAINED AT THE FOLLOWING POINTS AT STARTUP AND WITH
SUFFICIENT FREQUENCY TO INSURE THAT THE PROCESS MEETS THE PARAMETERS OF
THE SCHEDULED PROCESS?

-   TEMPERATURE INDICATING DEVICE IN THE HOLDING TUBE OUTLET YES \[ \]
    NO \[ \]

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-   TEMPERATURE RECORDER IN THE HOLDING TUBE OUTLET YES \[ \] NO \[ \[

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-   TEMPERATURE RECORDER-CONTROLLER IN THE FINAL PRODUCT HEATER OUTLET
    YES \[ \] NO \[ \]

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-   DIFFERENTIAL PRESSURE RECORDER IF A PRODUCT REGENERATOR IS USED YES
    \[ \] NO \[ \]

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-   PRODUCT FLOW RATE AS DETERMINED BY THE METERING PUMP OR AS
    DETERMINED BY FILLING AND CLOSING RATES. YES \[ \] NO \[ \]

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-   ASEPTIC SURGE TANK STERILE AIR OVERPRESSURE OR OTHER PROTECTIVE
    MEANS

YES \[ \] NO \[ \]

-   PROPER PERFORMANCE OF STEAM SEALS OR OTHER SIMILAR DEVICES YES \[ \]
    NO \[ \]

-   THE STERILIZATION OF PROCESSING EQUIPMENT OR "PRESTERILIZATION
    CYCLE" YES \[ \] NO \[ \]

######### PRODUCT STERILIZER OPERATION

# START-UP-113.40(g)(1)(ii)(a):

-   BEFORE THE START OF ASEPTIC PROCESSING OPERATIONS, IS THE PRODUCT
    STERILIZER AND ALL PRODUCT CONTACT SURFACES DOWNSTREAM BROUGHT TO A
    CONDITION OF COMMERCIAL STERILITY? 113.40(G)(1)(II) YES \[ \] NO \[
    \]

# PRODUCT TO PRODUCT REGENERATOR -- 113.40(g)(1)(ii)(c):

-   DO RECORDS INDICATE PRESSURE ON THE STERILE SIDE OF THE REGENERATOR
    LESS THAN 1 LB. PER SQ. INCH GREATER THAN PRESSURE ON THE
    NON-STERILE SIDE OF THE GENERATOR?

YES \[ \] NO \[ \]

-   IF YES, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? YES
    \[ \] NO \[ \]

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-   IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS".

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-   A PRODUCT TO PRODUCT REGENERATOR IS NOT USED \[ \]

PROPER SPEED OF METERING PUMP -- 113.40(g)(1)(i)(f) --

-   WAS THE METERING PUMP OPERATING PROPERLY TO ASSURE NO MORE THAN THE
    MAXIMUM PRODUCT FLOW RATE (PROPER RESIDENCE TIME) IN THE HOLDING
    TUBE? YES \[ \] NO \[ \]

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-   IF NO, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? YES
    \[ \] NO \[ \]

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-   IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS".

TEMPERATURE DROP IN PRODUCT STERILIZING HOLD TUBE -- 113.40(g)1)(ii) -

-   WERE THERE ANY INCIDENCES OF TEMPERATURE DROPS IN THE HOLD TUBE
    BELOW THAT SPECIFIED IN THE SCHEDULED PROCESS? YES \[ \] NO \[ \]

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-   IF YES, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? YES
    \[ \] NO \[ \]

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-   IF NO, REPORT DETAILS UNDER THE CAPTION "PROCESS DEVIATIONS".

# BACK-PRESSURE VALVES/ORIFICES

-   WHERE ARE BACKPRESSURE VALVES/ORIFICES LOCATED IN THE ASEPTIC
    PROCESSING SYSTEM?

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-   HOW DOES FIRM MONITOR THE PROPER FUNCTIONING OF BACKPRESSURE VALVES?

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-   WERE BACKPRESSURE VALVES OPERATING PROPERLY DURING THE INSPECTION?
    YES \[ \] NO \[ \]

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-   IF NO, REPORT ANY INCIDENCES OF PROCESS DEVIATIONS UNDER "PROCESS
    DEVIATIONS".

LOSS OF STERILE AIR PRESSURE OR OTHER PROTECTIVE LEVELS IN ASEPTIC SURGE
TANKS -- 113.40(g)(1)(ii)(c) --

-   WERE THERE ANY INCIDENCES OF LOSS OF COMMERICAL STERILITY IN ASEPTIC
    SURGE TANKS BECAUSE OF LOSS OF STERILE AIR OVERPRESSURE OR OTHER
    PROTECTIVE LEVELS? YES \[ \] NO \[ \]

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-   IF YES, WAS THE PRODUCT PROPERLY HANDLED AS A PROCESS DEVIATION? YES
    \[ \] NO \[ \]

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-   IF NO, REPORT DETAILS UNDER "PROCESS DEVIAIONS"

# RECORDING DEVICE - 113.40(2)(i)(a):

-   IS THE CONTAINER AND PACKAGING CLOSURE STERILIZATION SYSTEM AND
    PRODUCT FILLING AND CLOSING SYSTEM INSTRUMENTED TO DEMONSTRATE THAT
    THE REQUIRED STERILIZATION IS BEING ACCOMPLISHED CONTINUOUSLY? YES
    \[ \] NO \[ \]

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-   IS THERE ANY DOCUMENTATION SHOWING THAT COMMERCIALLY STERILE
    CONDITIONS ARE ACHIEVED AND MAINTAINED? YES \[ \] NO \[ \]

-   IS THERE ANY DOCUMENTATION SHOWING THE VALIDATION OF STERILIZING
    CONDTIONS?

YES \[ \] \[NO}

# [CONTAINER STERILIZING, FILLING AND CLOSING OPERATIONS - 113.40(g)(2)]{.underline}

EQUPMENT --

-   DO THE FIRM'S PROCEDURES ENSURE THAT THE CONTAINER AND CLOSURE
    STERILIZATION SYSTEMS AND THE PRODUCT FILLING AND CLOSING SYSTEMS
    ARE BROUGHT TO A CONDITION OF COMMERCIAL STERILITY BEFORE PACKAGING
    OPERATIONS BEGIN? 113.40(g)(2)(ii(a)

YES \[ \] NO \[ \]

-   ARE THE CONTAINER AND CLOSURE STERILIZATION SYSTEMS AND PRODUCT
    FILLING AND CLOSING SYSTEMS INSTRUMENTED TO DEMONSTRATE THAT THE
    REQUIRED STERILIZATION IS BEING ACCOMPLISHED CONTINUOUSLY?
    113(g)(2)(i)(a) YES \[ \] NO \[ \]

# ARE AUTOMATIC RECORDING DEVICES USED TO RECORD THE STERILIZATION MEDIA FLOW RATES, TEMPERATURE CONCENTRATION OR OTHER FACTORS? 113.40(g)(2)(i)(a) YES \[ \] NO \[ \] N/A \[ \] 

#  

# LOSS OF STERILITY - 113.40(2)(ii)(b):

-   IS THERE A SYSTEM THAT STOPS PACKAGING OPERATIONS OR ALTERNATIVELY
    SEGREGATES ANY PRODUCT PACKAGED WHEN PACKAGING CONDITONS FALL BELOW
    SCHEDULED PROCESSES?

YES \[ \] NO \[ \]

-   IN THE EVENT THAT STERILITY IS LOST IN THE PACKAGING SYSTEM, IS THE
    SYSTEM RETURNED TO A CONDITION OF COMMERCIAL STERILITY PRIOR TO
    RESUMING PACKAGING?.

YES \[ \] NO \[ \]

RECORDS - 113.40(g)(2)(ii)(c)

# ARE OBSERVATIONS AND MEASUREMENTS OF OPERATING CONDITIONS MADE AND RECORDED AT INTERVALS OF SUFFICIENT FREQUENCY TO ENSURE THAT COMMERCIAL STERILITY OF THE FOOD PRODUCT IS BEING ACHIEVED INCLUDING RECORDS OF:

# STERILIZATION MEDIA FLOW RATES YES \[ \] NO \[ \] N/A \[ \]

# TEMPERATURES YES \[ \] NO \[ \] N/A \[ \]

-   CONTAINER AND CLOSURE FLOW RATES YES \[ \] NO \[ \] N/A \[ \]

-   STERILIZATION CONDITIONS FOR BATCH SYSTEMS YES \[ \] NO \[ \] N/A \[
    \]

#### METAL CONTAINERS AND LIDS:

-   WHAT TYPE OF FILLING/PACKAGING SYSTEM IS BEING USED BY THE FIRM?
    (FOR EXAMPLE, METAL CONTAINERS AND CLOSURES STERILIZED WITH
    SUPERHEATED STEAM, FILLED & SEALED IN AN ASEPTIC CHAMBER)

-   DOES THE FIRM FOLLOW THEIR FILED SCHEDULED PROCESS FOR BRINGING THE
    CONTAINER & LID STERILIZATION EQUIPMENT TO A CONDITION OF COMMERCIAL
    STERILITY? YES \[ \] NO \[ \]

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-   DETERMINE & DOCUMENT THE NUMBER AND TYPE OF TEMPERATURE MONITORING
    SENSORS USED TO DEMONSTRATE THAT THE REQUIRED STERILIZATION IS
    ACCOMPLISHED --

-   ARE THESE THERMOCOUPLE SENSORS LOCATED IN THE MOST DIFFICULT TO
    STERILIZE AREA? YES \[ \] NO \[ \]

-   IS THE POSITION OF THE TEMPERATURE SENSORS AND EQUIPMENT THE SAME AS
    FILED WITH FDA? YES \[ \] NO \[ \]

-   LIST THE CRITICAL FACTORS BEING MONITORED DURING THE STERILIZATION
    OF CONTAINERS, LIDS, FILLING AND CLOSING EQUIPMENT (E.G.
    TEMPERATURE, STERILIZATION MEDIA FLOW RATE, ETC) --

-   IS THE MONITORING DATA FOR THESE CRITICAL FACTORS CONTINUOUSLY &
    ACCURATELY RECORDED? YES \[ \] NO \[ \]

-   DO INDICATING THERMOMETERS AGREE WITH RECORDING THERMOMETERS?

YES \[ \] NO \[ \]

-   ARE TEMPERATURE INDICATING AND RECORDING DEVICES (TIDS) PROPERLY
    CALIBRATED?

YES \[ \] NO \[ \]

-   IF YES, WHAT IS THE CALIBRATION METHOD AND FREQUENCY?

-   

-   IS TID CALIBRATION ACCOMPLISHED AT PROCESSING TEMPERATURE? YES \[ \]
    NO \[ \]

-   IF COLD STERILE WATER IS DIRECTED AGAINST THE BOTTOM OF CONTAINERS
    AFTER FILLING (OR ONTO THE LIDS PRIOR TO CLOSING), WHAT ARE THE
    FIRM'S CONTROLS TO ENSURE STERILITY OF THE WATER ON A CONTINUAL
    BASIS? --

-   DESCRIBE THE FIRM'S CONTROLS FOR ENSURING THE PROPER RESIDENCE TIME
    OF THE CONTAINERS AND LIDS IN THE STERILIZING MEDIUM (EXAMPLE --
    CONTAINERS/CLOSURE FLOW RATE CHECKED WITH A CALIBRATED STOP WATCH)
    --

-   WHAT IS THE METHOD AND FREQUENCY FOR TIMING DEVICE CALIBRATION? --

-   WHAT IS THE METHOD OF PREVENTING UNAUTHORIZED CHANGES IN
    CONTAINER/LID FLOW RATE DURING STERILIZATION? --

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-   IF AN AUTOMATIC DEVICE IS USED TO MONITOR CONTAINER/CLOSURE FLOW
    RATES, HOW DOES THE FIRM ASSURE THE ACCURACY OF THESE DEVICES?

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-   HOW DOES THE FIRM ASSURE THAT CONTAINERS AND COVERS ARE CLEAN AND
    DRY PRIOR TO ENTERING THE STEAM CHAMBERS

####### 

#### GLASS, PLASTIC AND PAPERBOARD CONTAINERS:

-   WHAT TYPE OF FILLING/PACKAGING SYSTEM IS BEING USED BY THE FIRM?
    (FOR EXAMPLE, TETRAPAK PAPERBOARD FORM/FILL/SEAL USING HYDROGEN
    PEROXIDE AND HEAT AS STERILANTS; PRE-FORMED MULTI-LAYERED PLASTIC
    CUPS STERILIZED, FILLED & SEALED IN AN ASEPTIC CHAMBER USING
    HYDROGEN PEROXIDE AND HEAT AS STERILANTS. ; GLASS BOTTLES FILLED &
    SEALED IN AN ASEPTIC CHAMBER USING STEAM AS A STERILANT; PLASTIC
    CUPS BLOW MOLDED/FILLED, SEALED AND STERILIZED IN THE MOLD. INCLUDE
    THE MANUFACTURER AND MODEL NO. OF THE ASEPTIC FILLING MACHINE.

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-   HOW IS HEAT APPLIED FOR CONTAINER STERILIZATION?

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-   DESCRIBE THE FIRM'S PROCEDURE FOR MONITORING ALL CRITICAL FACTORS
    FOR THE SCHEDULED PROCESS --

-   ARE SENSORS FOR MONITORING THE ABOVE CRITICAL FACTORS PROPERLY
    LOCATED TO PROVIDE ASSURANCE THAT THE FACTORS ARE MONITORED AT THEIR
    COLDEST OR WEAKEST POINT? YES \[ \] NO \[ \]

-   IF CHEMICAL STERILANTS ARE SPRAYED IN ASEPTIC CHAMBERS, ARE SPRAY
    VOLUMES CONTROLLED BY NOZZLES \[ \], PERISTALTIC PUMPS \[ \], OTHER
    \[ \] \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

-   WHAT IS THE FIRM'S PROCEDURE FOR ASSURING THE USE OF PACKAGING
    MATERIALS OF HIGH MICROBIOLOGICAL QUALITY?

-   IS THE FILLING/ PACKAGING MACHINES DESIGNED TO AUTOMATICALLY SHUT
    DOWN IN THE EVENT OF A FAILURE TO MEET SPECIFIED CRITICAL FACTORS ?
    YES \[ \] NO \[ \]

-   WHO CHECKS THE AUTOMATIC CONTROLS AND HOW FREQUENTLY?

-   HOW DOES THE FIRM CHALLENGE THE AUTOMATIC CONTROL SYSTEM?

-   UNDER WHAT CIRCUMSTANCES WOULD AN AUTOMATIC MACHINE BE OPERATED IN A
    MANUAL MODE TO PACK PRODUCT AND WHO WOULD HAVE THE AUTHORITY TO
    APPROVE THIS?

-   ARE THERE ANY MANUAL CONTROLS THAT ARE CRITICAL TO THE SCHEDULED
    PROCESS? YES \[ \] NO \[ \] IF SO, HOW WOULD A PROCESS DEVIATION BE
    DETECTED AND HANDLED BY THE FIRM?

-   DESCRIBE THE FIRM'S PROCEDURE FOR TESTING HYDROGEN PEROXIDE RESIDUAL
    ON PACKAGING MATERIAL --

-   IS THE HYDROGEN PEROXIDE RESIDUAL LEVEL (FROM RECORD REVIEW) IN
    COMPLIANCE WITH PART 178.1005(D)? YES \[ \] NO \[ \]

##### THERMOFORM-FILLED-SEALED PLASTIC CONTAINERS PRE-STERILIZED BY HEAT OR CO-EXTRUSION:

-   WHAT TYPE OF FILLING/PACKAGING SYSTEM IS BEING USED BY THE FIRM?
    (FOR EXAMPLE, MULTI-LAYERED PLASTIC WEB IS DIPPED IN HYDROGEN
    PEROXIDE BATH AND THEN HEATED AND FORMED INTO CUPS/FILLED/SEALED
    WITH FLEXIBLE LIDSTOCK IN AN ASEPTIC CHAMBER -- BOTH BODY AND LID
    STERILIZED BY HYDROGEN PEROXIDE AND HEAT BEFORE FILLING). INCLUDE
    MANUFACTURER AND MODEL NO. OF ASEPTIC FILLING MACHINE.

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-   DESCRIBE THE FIRM'S PROCEDURES FOR MONITORING ALL FACTORS CRITICAL
    TO THE SCHEDULED PROCESS.

-   FOR STERILE AIR THAT PROVIDES OVERRIDING AIR PRESSURE DURING
    PROCESSING OPERATIONS, HOW OFTEN ARE THE AIR FILTERS CHANGED AND
    DOES THIS FREQUENCY COMPLY WITH THE FREQUENCY DELINEATED IN THE
    SCHEDULED PROCESS? YES \[ \] NO \[ \]

-   IS THE CHANGE OF AIR FILTERS DOCUMENTED? YES \[ \] NO \[ \]

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-   FOR MULTI-LAYERED CONTAINER BODIES AND LID STOCK DURING F/F/S
    OPERATIONS WHERE THE OUTER LAYER IS STRIPPED AWAY TO EXPOSE AN INNER
    STERILE LAYER, HOW DOES THE FIRM ENSURE PROTECTION OF THE STERILE
    INNER LAYER AS THE PACKAGING MATERIAL IS RECEIVED AND USED?

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-   DESCRIBE THE FIRM'S PROCEDURE FOR ENSURING THAT EQUIPMENT IS BROUGHT
    TO A CONDITION OF COMMERCIAL STERILITY AND THAT EXPOSURE OF THE
    STERILE INNER LAYER TO THE STERILE ZONE AT THE BEGINNING OF THE
    PRE-STERILIZATION CYCLE IS PERFORMED IN SUCH A MANNER AS TO MAINTAIN
    THE STERILITY OF BOTH THE PACKAGING MATERIAL AND THE STERILE
    AREA.BAG IN BOX PACKAGING SYSTEMS

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-   DESCRIBE THE PACKAGING SYSTEM INCLUDING MANUFACTURER, MODEL NO.,
    OPERATION OF THE FITMENT, THE MEDIA USED TO STERILIZE THE FITMENT
    AND HOW THE STERILIZATION PROCESS AND ALL CRITICAL FACTORS SPECIFIED
    IN THE SCHEDULED PROCESS ARE CONTROLLED AND MONITORED.

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-   HOW IS THE MULTI-LAYERED PLASTIC CONTAINER STERILIZED? (FOR EXAMPLE,
    THE BAG IS PRE-STERILIZED FOR THE SUPPLIER BY AN OUTSIDE CONTRACTOR
    USING GAMMA RADIATION.

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-   HOW DOES THE FIRM ASSURE THAT STERILE PACKAGING MATERIALS ARE
    RECEIVED AND MAINTAINED STERILE?

-   IF CHEMICALS ARE USED TO STERILIZE THE FITMENT, HOW IS THE CHEMICAL
    CONCENTRATION MONITORED?

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-   DESCRIBE THE FIRM'S PROCEDURE FOR ENSURING THAT EQUIPMENT IS BROUGHT
    TO A CONDITION

-   OF COMMERCIAL STERILITY PRIOR TO THE START OF FILLING

# [INCUBATION - 113.40 (3)]{.underline} 

EXPLAIN THE INCUBATION PROCEDURES USED BY THE FIRM, INCLUDING THE NUMBER
OF SAMPLES, INCUBATION TIME AND TEMPERATURES, AND THE FOLLOW UP
PROCEDURES FOR ANY POSITIVE RESULTS.

# [PROCESS DEVIATIONS -- PART 113.89]{.underline}

-   ARE PROCESS DEVIATIONS MAINTAINED IN A SEPARATE FILE OR LOG?

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-   REVIEW RECORDS DOCUMENTING PROCESS DEVIATIONS (INCLUDING PROCESS
    DEVIATION FILE).

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-   WHAT IS THE FIRM'S PROCEDURES FOR HANDLING PROCESS DEVIATIONS -- FOR
    EXAMPLE, A DROP IN PRODUCT TEMPERATURE IN THE HOLDING TUBE OR OF
    DIFFERENTIAL PREESSURE IN THE PRODUCT TO PRODUCT REGENERATOR BELOW
    SPECIFIED LIMITS?

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-   WERE ALL PROCESS DEVIATIONS HANDLED IN ACCORDANCE WITH THE FIRM'S
    PROCEDURES AND PART 113.89? YES \[ \] NO \[ \]

# [CONTAINER CLOSURE EVALUATION -- Part 113.60(a)(1) & (3)]{.underline}

-   DO THE FIRM'S CONTAINER INTEGRITY EVALUATION PROCEDURES COMPLY WITH
    THE VISUAL AND TEARDOWN REQUIREMENTS OF PART 113.60(A)(1),92) & (3)?

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-   DESCRIBE THE FIRM'S CONTAINERS AND THEIR PROCEDURES FOR ENSURING
    CONTAINER INTEGRITY (INCLUDE THE FIRM'S SAMPLING, HANDLING & TESTING
    OF INCOMING CONTAINERS AND PACKAGING MATERIALS, THEIR VISUAL AND
    TEARDOWN TEST PROCEDURES FOR FINISHED PRODUCT CONTAINERS TO ASSURE
    CONTAINER INTEGRITY.

# [POST-PROCESS CONTAINER HANDLING]{.underline}

-   ARE CONTAINERS PROPERLY HANDLED DURING THEIR CONVEYANCE FROM FILLING
    AND PROCESSING AREAS OF THE PLANT TO WAREHOUSE LABELING AND STORAGE
    AREAS TO ASSURE MAINTENANCE OF PACKAGE AND SEAL INTEGRITY? Y ES\[ \]
    NO \[ \]

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-   DESCRIBE THE FIRM'S POST-PROCESS HANDLING PROCEDURES -

# [TRAINING -- Part 113.10]{.underline}

-   HAS THE FIRM MET THE REQUIREMENTS OF PART 113.10 FOR ATTENDANCE AT
    BETTER PROCESS CONTROL SCHOOL? YES \[\] NO \[ \]

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-   DESCRIBE THE FIRM'S TRAINING PROGRAM FOR OPERATORS OF PRODUCT AND
    PACKAGE STERILIZATION SYSTEMS -