MISSION HILLS, S.A. DE C.V.

Microbiological Environmental Air Monitoring Protocol

INNOPHOS - DICAL FACTORY
INAA-VQMIC0065-001-000



Prepared by
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Laboratory Supervisor
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Plant Microbiologist
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Microbiology Manager
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MISSION HILLS, S.A. DE C.V.
Microbiological Compressed Air Monitoring Protocol
INNOPHOS DICAL FACTORY
INAA-VQMIC0065-001-000
December, 2013

1. SCOPE

This protocol describes the activities of the microbiological environmental monitoring for the Innophos
DICAL Factory to determinate micro limits and sampling frequency.

2. PRINCIPLE

The plant environment may directly or indirectly affect the microbiological quality of the finished
products and raw materials. Evaluation of the environment through analysis of samples (both air and
surface) allows the microbiologist to evaluate both the magnitude and the kind of contamination. A viable
environmental monitoring program should provide enough information to determine that the manufacturing
environment is operating in an adequate level of microbiological control.

Microbiological environment monitoring and verification programs may be designed and executed to
meet one or more of these objectives; 1) verification of the effectiveness of the cleaning area schedule 2)
determination of the frequency required for the cleaning of areas, 3) evaluation of environmental sources of
microorganisms 4) evaluation and verification of the environmental air status to execute corrective and
preventive actions if needed.


3. PROCEDURE

A. The routine environmental monitoring program should be established and include the following
elements:

i. Sample Site Rationale
a. Sample site selection should be based on an analysis of the risks associated with raw
material, bulk or finish product contamination.
Sampling sites should be selected in high traffic areas or sensitive manufacturing areas
where exists potential of contamination by being on direct or indirect contact with
contaminated surfaces.
Samples should be taken during normal activity.
At the onset of a program, more samples need to be taken in order to establish a
statistical baseline. On an ongoing basis, the number of samples/sites may be
reduced.

ii. Site Maps will make analysis and trending of the data more meaningful.
a. Area maps should be developed.
b. All sample sites should be detailed on the area maps.

iii. Sampling procedure
a) According to QMIC0014 the sampling procedure is primary method with SAS Super 180 Air
Sampler, which is evaluated by sampling environmental air.
b. Initial
The monitoring frequency should be once per week for twelve weeks at each sample
site.
The data should be charted to be able to identify trends.



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MISSION HILLS, S.A. DE C.V.
Microbiological Compressed Air Monitoring Protocol
INNOPHOS DICAL FACTORY
INAA-VQMIC0065-001-000
Establish alert and action levels for each site. This limits established must be below the
specifications according to regulation and must not affect the release of the finish
product.
Assign sample points according to the different areas in the plant
Calculate the mean and standard deviation (SD) of the different sample sites.
The alert level can be established at two sigma from the mean.
The action level can be established at three sigma from the mean.

According to the data sampling the frequency will be established following the criteria
stated in QMIC0065
d. Data analysis
Identification of the isolates may be necessary during an investigation in order to
correct and exceeded action level, this will be performed according to QMIC0020,
Gram Stain Procedure.
Identification may be of biochemical (API system)

iv. Investigative response to exceeded alert/action levels shifts from the established data
patterns may indicate changes in the environment or work practices that impact quality.
a. Single Site Exceeded Alert Level single isolated occurrence
Review historical data for site.
Notify supervisor personnel via email.
b. Single Site Exceeded Alert Level multiple consecutive occurrences (two or more)
Equal to an Action Level occurrence, proceed to c
c. Single Site Exceeded Action Level single occurrence
Notify appropriate supervisor personnel.
Retest sample site.
Review historical data for site.
Notify supervisor personnel via email.
If retest does not confirm original test results, no further action is required.
If retest confirms original result (exceeded alert level), execute a non-conformance
report and initiate an investigation to include (as applicable):
Review of historical data.
Review of air-handling system maintenance.
Review of product logs/records.
Review of activity during events.
Observation of sampler technique and retraining as indicated.
Review of sampler training records
Review of cleaning and sanitization procedures and records.
Assessment of the potential effect on product quality.
Review of laboratory records through a laboratory investigation report.
Identification of representative organisms recovered from the site.
Based on the investigation, initiate necessary change control and corrective actions
which may include:
Retesting of the affected areas will be performed depending on the extent of the
problem.
Immediately cleaning and Moping of the area(s) involved in out of limits. Must
include ceiling, floor and equipment (externally) to minimize bioburden.
If it is necessary depending on the sampling point where the out of limit events
Additional finished product testing to ensure its quality.



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MISSION HILLS, S.A. DE C.V.
Microbiological Compressed Air Monitoring Protocol
INNOPHOS DICAL FACTORY
INAA-VQMIC0065-001-000
Retraining/reinforcement of cleaning and sanitization procedures.
Modifications of practices or processes.
Increased testing, i.e. daily or weekly

Upon completion of corrective actions and change control, resample areas and
document results.

B. Investigational monitoring may also be necessary and should follow the same basic approach as 3A.

C. Personnel involved with environmental sampling were properly trained in QMIC0014.

i. Date and signature of investigator
ii. Results of investigative response (if applicable) as in 3 Av.
iii. Corrective actions

4. REFERENCES

QMIC 0014 Microbial monitoring of environmental and compressed air
QMIC 0065 Microbiological environmental program for the laboratory and plant

5. RESULTS

5.1Summary Data

Table.1 Average, Standard Deviation and Alert and Action Limits for each area.



5.2 Attachments

a. Environmental check list sampling site
b. Sampling points by area
c. Sampling results table by area
d. Sampling results charts by area


6. CONCLUSION

The preventive monitoring of environmental volumetric air will be follow and taken into consideration the
action levels that result from this study (see the summary data).

Regarding that the areas in Oral Care Focus Factory are not totally controlled, to obtain a result that exceed a
total aerobic count in its action level values it will be emitted a recommendation by the Microbiology
Laboratory to the Responsible of the Area in the Focus Factory to conduct a corrective action by performing
a cleaning of the area and if required so, the maintenance of the HVAC related to that area in order to
reduce the environmental bioburden and restart with this process once this action are implemented
AVERAGE STD DEVIATION ALERT LEVEL ACTION LEVEL
UFC/m3 UFC/m3 UFC/m3 UFC/m3
Innophos - DICAL 63 61.54 186 248
AREA



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MISSION HILLS, S.A. DE C.V.
Microbiological Compressed Air Monitoring Protocol
INNOPHOS DICAL FACTORY
INAA-VQMIC0065-001-000
Attachment A . Environmental Check-list Questionnaire for Sampling Site
(Risk Assessment)
Table2. QMIC0065 Questionnaire Evaluation
.


Question
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D
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C
A
L
Is the room adjacent to a busy area?
Does the area hace a high level of personnel
transit?
Is the area exposed to outside air, high humidity,
and/or warm temperature?
Y
Are there any open or exposed areas where
water can come in?
Is there any history of flooding or water
stagnation?
Does the area have any sinks or active drain
trough(s)?
Y
Is the area in an open processing section?
Is there periodic exposure to direct human
contact?
Y
Is there any product / WIP filling, making,
storage?
Is there any aseptic sampling, handling and
related hygienic processes conducted in the
area?
Y
Does the area receive in-coming materials? Y
Is there any raw material and component
preparation?
Is the area a designated route of material
transfer?
Y
Is there any history of high microbial counts or
association with OOS?
Does the area have filtered recirculated air?
Is the area supplied whith HEPA filtered air and
positive pressure?
Is the area classified as a GMP room? Y
Is there any microbiological testing being
performed in the room?
Y
Is there a requirement to wear GMP compliant
uniforms (mask, gloves, hair net) in the area
Y
Does the area or equipment use compressed
air?
Y
Is the room a designated buffer zone (air lock),
staging zone or storage area?
Is there any material dumping station in the
room?
Y
Is there a blower or drains located near
equipment?
Y



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MISSION HILLS, S.A. DE C.V.
Microbiological Compressed Air Monitoring Protocol
INNOPHOS DICAL FACTORY
INAA-VQMIC0065-001-000
Attachment B. Sampling points by are

Diagram 1. Sampling Points: Innophos - DICAL






Attachment C. Sampling results table by area

Table3. Historical Data collected



WEEK / AREA
Innophos -
DICAL
1
66
2
22
3
188
4
56
5
52
6
14
7
51
8
26
9
13
10
149
11
94
12
32
AVERAGE 64
Sampling point



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MISSION HILLS, S.A. DE C.V.
Microbiological Compressed Air Monitoring Protocol
INNOPHOS DICAL FACTORY
INAA-VQMIC0065-001-000
Attachment D. Sampling results charts by area

Chart 11. Innophos-DICAL 12 week trend