D-115

Environmental Monitoring of Air and Surfaces

Section D — Laboratory Operations and Specifications Revision 11 26 pages

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1.0 Purpose
The purpose of this procedure is to set guidelines for the microbiological Environmental
Monitoring Program (EMP) of Ion Labs two buildings (Operations/Administration and
Warehouse). This program is used to verify the effectiveness of the facility’s cleaning,
maintenance and GMP programs at lon Labs Inc. The EMP will focus on environmental air and
non-praduct contact surfaces within the plant processing areas during normal production periods.
Scope

This procedure applies to all production areas and used to determine the effectiveness of the plant
sanitation program, ‘This SOP outlines the sampling planto execute microbiological testing of air

and non-product contact surfaces for an entire year, Samplepoints are defined by site location

and testing type, with corresponding aleri/action limits established. All defined locations are
tested at least once each quarter and test results are documented on the forms provided. A

summary report is generated each quarter to summarize observed trends, excursions events and
corrective action(s) taken during that period.

Responsibility

ttaoNt i itis the responsibility of QC Laboratory Analysts to follow this procedure,

J itis the responsibility of QC Laboratory Mana gement to nnplement this procedure and to

ensure that the procedure is being followed,

3.3 Itis the responsibility of OC Laboratory Management to keep this procedure aligned with

current practices and to oversee validations and recovery studies.

[SOP

Standard Operating Procedure 1_ SOP No
.E nvironmental Monitwoeri ng of Ai; r and S—urf aces | Dn--L1I1S5 | u1 Pa°ge2 of 26

4.0 Definitions

4] Fone 1: Praduct Contact Surface (PCS) — surfaces that come into direct contact with

ingredients and/or product

42 Wen-product Contact Surface (Nen-PCS} — surfaces that do not come inte direct
contact with the product and/or components

45 fone 2 ~ non-PCS adjacent to or within close proximity to the PCS; areas that, if
contaminated, could reasonably lead to PCS contamination; examples include (hut are

not limited to):

4.3.1 Exterior of equipment that is im contact with the product

ehw dat aS Conveyor belts, legs/framework in the filling process, and any areas of the filling
equipment that is near floor drains

xa aeL oo[ Platforms and handrails in Blending

4.3.4 Equipment housing (panel buttons, operator control buttons)

+ daL iaC Floor drains below conveyors

Work surfaces adjacent to unsealed product (i... tables}» ,eka og yO

4.3.7 Ventilation and air handling equipment

“hat fone 3 ~ the arca that immediately that surrcunds Zone 2; areas that, if contaminated,

could lead to PCS contamination with human intervention (.ec., employee using
compressed air to clean floors or a piece of equipment): examples include (bat are not

limited to}:

4.4.1 Permanently mounted air and water hoses

4.4.2 Floors and floer drains

[SOP

Standard Operating Procedure SOP No | Rev Pave 3 of 6
Envir ronmental M” o* nit° oriv ng of Ais r andM4 S“u~ rfiag ces D-oo. US4 La, “a.e a REAP

4.4.2 Damaged floors, Le., cracks, crevices, missing plece of concrete
+
tan
444 Corridors

44.5 Walls

Zone 4 — the area immediately surrounding Zone 3, generally considered a remote area;

area which, if contaminated with a pathogen, could lead ta contamination of Zone 3 via
the actions of humans or machinery; examples include (but are not limited to):

4.5.1 Employee locker rooms

45.2 Warehouse

4.3.4 Hallways

4.6 EMP —~Environmental Monitoring Program

4.7 EM - Environmental Monitoring

48 TSA —Tryptic Soy Agar

49 SBA ~ Sabouraud Dextrose Agar

4,10 SMPTE —~No More Than

4.41 CRU ~ Colony Forming Units

442 QC - Quality Control

4re .J34 A. ler. t. Loie mi*t ~ i“ ndtie catasi on that. mic. robiwaol COUNT_ I# S cn reas« e i«n area

[SOP

Standard Operating Procedure — SOP Ne Rey
D-115 ii Page4 of 26
Environmental Monitoring of Air and Surfaces
ons

4.14 Avtion Limit — signals an apparent deviation from normal process conditions. Requires
immediate action

Confirmed Positive — positive result determined using identification noa iw

416 10 — Installation Qualification

4.17 OO — Operation Qualification

4.18 PQ -~ Performance Qualification

419 CAPA — Corrective and Preventative Action

4.20 (GMP -~ Good Manulacturing Practices

SG References

5.1 C-201, SOP, Deviation and Investigation Procedure

3.2 D-{01, SOP, Laboratory Housekeeping

yaC a C403, SOP, Change Control Procedure

Ai sp“ 4-106, Documentation Guidelines for cGMP Records

5,5 C-3501, SOP, Document Control

5.7 QS-108, SOP, Corrective and Preventative Action (CAPA)

5.8 C-105, SOP, Protocol and Report Documentation Requirements

39 PRTCL-21-0037, Protocol, Environmental Monitoring of Air and Surfaces

5.10 The FDA's 202] draft guidance is a key resource for understanding how to control

microbiological quality in non-sterile drag manufacturing.

[SOP

Standa M rd o O n pe rating ‘ Procedure S D O 1 P 1 N 8 o | R i ev | Page o So n f 2 e 6

Environmental Monitoring of Air and Surfaces
acr ra
reteet
ema
11 US. Pharmacopoeia, USP42-NP37 2S (2020). < 1116> Microbiological Evaluation of ae
;
Clean Rooms and Other Controlled Environments
5.12 Parenteral Drug Association Technical Report No. 13. (2014). Fundamentals of an
Environmental Monitoring Program (Revised Edition)

130 D-115-F2, Form, Alert/Action and Positive Result Resarnple Log yt

O-115-F 1, Form, Air and Surface Sampling Log yS sp

D-115-F3, Form, Preliminary Pathogen Screening Log. sS yaL

6.0 Required Supplies, Media, and Equipment

6.1 Sterile Swabs and/or Sponges

6.3 Sabouraud Dextrese Agar (SDA) plates and contact plates

6.4 20"C to 25°C and 30°C to 40°C Incubators (adjustable)

6.5 Biological Safety Cabinet

7.0 Procedure

7.1 Sample Labeling and Preparation

71 Obtain media and confirm it is net expired as of date of use.

712 Label swabs, contact plates and air plates with corresponding site location,

(See Attachment | and 2)

3~ aN Sampling Environmental Surfaces - Swab Sampling for TAPC and Yeast & Mold on

[SOP

| SOP No | Rev
Standard Operating Procedure Page 6 of 26
Environmental Monitoring of Aur and Surlaces D-TES : Bl “ |

7.2.1 Allow swab to acclimate to ambient temperature (21-25 °C) before use. Use

thamb to break snap-valve by bending bulb, releasing liquid into tube and

7.2.2 Drain swabbing should consisi of those surfaces that can harbor bactena and

then be cortact transferred to other areas of the business.

Surface Drains eeS NM de

7.2.3.1 Before sampling, ensure that no probiotics are being actively handled an
the site location. Do not sample processing roams running probiotics.

Surface drain monitoring testing will be conducted afier a major

cleaning procedure is completed.

3.2 Pull swab out of nube and swab an area (44 inches) for flat surface and J SB
7
a representative area size for uregular surfaces.

7.2.3.3 Replace swab in tube and deliver to lab for inoculation.

724 Trench Drains (Gummy Lines)

7.24.1 Trench drains typically are comprised of multiple sections and individual

COVers,

¢24.2 Pull swab out of tube and swab an area (4x4 inches) for flat surface and

a representative area size for irregular surfaces.

]~~ "«3| Roaaqnptfiuczvee th“eO Yi ntem6raxyi or ofg hth e bi5 ologi7 cal sries afeeatt y cabi4 net as per Sa O5 P D1-10]

Laboratory Housekeeping before plating.

T7I2S6 SShhaalkees ddeevwiccee 110 sCeOcLEaTnTEd sS to meiyxe an7 d poIuErP cPooynwtrkeenwtt i7 n 9+ 9ml bufofee red: peptone

water Tor 17100 dilution. Vortex and place S00 uL in two Petri dishes.

la i dw Pao ur “TPrerntyicep tic SGoayw AgAgaare aannadl SGaalb ora;n d Dext, rose Agar onto one of each plate and
swirl gently to mix.

[SOP

Standard Ooeratine Procedure SOP Ne | Rev _
Standard Operating Proc nus | ou Page 7 of 26
}
Environmental Monitorme of Air and Surfaces ! i
i
a
728 Incubate TSA plates at 33°C + 2°C for 48-72 hours. Incubate SDA plates at
23°C & 2°C for 5-7 days.

7.2.9 All data collected for swabbing testing of the drains will be documented on
Farm D-1145-Fi Air and Surface Sampling Log.

7.3 Sampling Environmental Surfaces - Contact Plates Sampling for TAPC and Yeast &
Mold

7.3.1 Allow contact plates (TSA and SDA) to acclunate to ambient temperature (21-25
pate,
°C) before use,

7.3.2 Before sampling, ensure that no probiotics are being actively handled on the site

location, Da mot sample processing rooms running probiotics. Surface
monitonng testing will be conducted after a major cleaning procedure is

compisted,

Remove cover, place contact plate directly on surface, and press sli.ghtly. Remove 23£ dei

from surface and cover.

Incubate TSA plates at 33°C + 2°C for 48-72 hours. Incubate SDA plates at ~ oot ei

23°C & 2°C for 5-7 days.

das doL A All data collected for contact plate testing will be documented on Form D-115-
Pl Air and Surface Sampling Log.

74 Environmental Air ~ Settling Plate Sampling for TAPC and Yeast & Mald

co7rd4.0 Allow plates (TSA and SDA) to acclimate to ambient temperature 21-25 °C)

742 Delore sampling, ensure that no probiotics are being actively handled on the site

location, Do not sample processing roorms running probiotics. Air monitoring
testing will be conducted after a major cleaning procedure is completed,

CONFUDENTLAL: For ABI Ton Labs use only
a,

[SOP

S S t t a a n n d d a a r r d d O O p p e e r r a a t t i i n ng g Pro Pr c oc e dure S D O - P 11 N 5 o | : R e 7 v Pag§ eof 3 2 G 6
Environmental Monitoring of Air and Surfaces

74.3 Place one prepared SDA Plate and one TSA plate in the sample site location
with covers rernoved.

7.4.4 Leave the plate exposedfor a minimum of 1S minutes un cach location.

7AS Incubate TSA plates at 33°Ca: 2°C for 48-72 hours.

7.4.6 Incubate SDA plates at 23°<C 2°C for 5-7 days.

3w AW data collected for air testing will be documented on Porm D-113-F1 Ag and aE

Surface Sampling Log,

7.5 Reporting Results

7.5.1 Count coloniesand recorasd CFU/plate.

ea 43C 2 Ifne colonies appear on the plate, the result should be reported as “ND”,

73.3 if TNTC results are ohtamed on sites where probiotics were processed, thes
results should be invalided and a new sample must be collected. The location site

should be sanitized prior to re-sarnpling.

7.5.4 If growth is observed on TSA or SDA, further isolate colonies with distinctive

morphologies, if applicable. Non-selective media such as TSA or Blood Agar

should be used for bacteria, and SDA for yeast isolation. Mold screening is not
ane
required and isolation from TNTC plates is not performed.

~~ kat tP bach isolated growih will be labeled a8 sample location (See Atiaclanent 1 ~
Saniple Site Rey) + colony isolated (A, B. C...3.

7.5.5.1 For instance, B5-9A plate will refer to Blending Room 5 ~ Table, and the
letter A is assigned to the firstisolated colony from BS-9 environmental

plate. If multiple colonies are isolated from same plate, next isolation

plate willbe B5-9B, B5-9C.,

[SOP

ynn nnnenn
eroy1
,
Standard Operating Procedure SOP No | Rev
Environmental Monitoring of Air and Surfaces
i eeb pis 11 Page 9 of 26

fw nc
Incubate TSA or Blood Agar at 33°C + 2°C for 24-48 hours.
Incubate SBA plates at 23°C sb 2°C for 5-7 days.
Inveulate the isolated growth onto pathogen specific media to determine the
presence of pathogens. Refer SOP D-715.0 Microbial Limit Testing using Agar
Plates. Commercially prepared chromogenic media may be used as supporting
media for presumptive identification. Follow vendor instructions for incubation
time and temperatures.
7.5.8.1 Alternatively, identification can be performed directly from growth

isolated on TSA, Blood Agar or SDA, to confirm presence or absence of

specific pathogens. Reference SOP D-1016 Microbial Identification via
Biolog Microstation for identification instructions.

Tf typical growth is observed on the pathogen specific media, then this growth
requires a contirmatery identification. Reference SOP D-LO016 Microbial

identification via Biolog Microstation for identification mstractions.

if ne growth or atypical growth 1s observed report as “ND for specific pathogen

screening and no more testing is required. Document results on Form D-115-F3

Preliminary Pathogen Screening Log.

&.0 Specifications

5.1 Environmental Monitoring of Air and Surfaces for Alert/Action Limits specifications:

Air 8&8
| QNI
ab
laW
so
daC surlace (Contact) BL
x
Surface (Drains) 2022 - . 2869
domae aoh+ Positive results are obtained with the conlinned identification of one of the following
organisnis:

[SOP

Standare Operating Procedure SOP Ne | Rev | —
_ - D-115 11 | Page 10 ef 26
Environmental Monitoring of Airand Surfaces 6 4"" a

L. monocytogenes Negative

8.3 Any presumptive positive or typical growth observed, should be identified to the species

level to continm absence or presence of the organisms listed above. Reference SOP 1-
1016 Microbial Identification via Biolog Microstation for identification instructions.

*.0 Corrective Action

9.4 Exceeded Alert Limit

9.1.1 When results exceed the specified alert limit, a member of operational management

must be notified, and the affected area resampled.The location site should be
sanitized prior io resampling. Document on form D-115-F2 Alert/Action and

Positive Result Resample Log.

9.2 Fesceeded Action Limit or Confirmed Pasitive

9.2.) Corrective actions must be taken when results exceed Action limits, or a confirmed

positivies foundin any zone. Verified presence of a pathogen listed in this SOP is
an action linvit fatlare.

So to 9.2.2 Operational and Quality management must be immediately notified and the even

9.2.3 QC personnel initiate a deviation after confirmation of the initial action limit failure
result is obtained. Corrective actions will he documented on forms C-201-F 1. Refer

to SOP C-201 Deviation and Investigalion Procedure. Deviations for an event

exceeding action limits may inchide risk assessment and/or CAPA, Alternatively,
initiation of a CAPA following SOP QS-108 Corrective and Preventative Action

[SOP

Standard Operating Procedure SO G P E N N o | Re+ v || Page” 11 of 26
Environmental Monitoring of Air and Surfaces : D-HS i i - }
|
(CAPA) may be performed. DEV or CAPA number assigned Gf applicable), will be

documented on Form D-115-F2 Alert/Action and Positive Result Resample Log,

Any product produced in the impacted area should be identified and documented on ep o,b nitkaa‘
sP
Deviation or CAPA initiated, along with the disposition decision based on the
associated risk assessment.

O.2.5 Frequency of sampling of the impacted area and the areas directly surrounding the

impacted area will be increased from once per quarter to once per business day until

at least three consecutive results are below the action limits. Areas should be
sanitized prior re-sampling gets started. Ail resamples taken will be documented on

Porm D-L{5-F2 Alert/Action and Positive Result Resampie Log.

9.2.6 Increased sampling rates described above do not need to occur on days where there

is no activity other than corrective actions intended to rescive the observed result(s).
Whether the area is used for actual production activity depends on assaciated risk

assessment.

2.7 After achieving three consecutive results below the action limits, resume the regular

sampling frequency.

92.8 Tf re-sampling and/ or the areas directly surrounding the impacted area still show
concerning or pasitive results then alternative corrective action(s) should be

explored to correct any GMP deficiencies based on the findings. These may include:

22.81 Review of microbiological sampling methods and techniques

9.2.8.2 Reinforce or retrain hygienic practices with appropriate employees

9.2.8.3 Revision of the sanitization program, inclading selection of

antimicrobial agents, application methods, and frequencies

9.2.8.4 Eliminate water if present

[SOP

Standard Operating Procedure S p O i P s No | > R i ev | Page i — ofl
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Environmental Monitoring of Air and Surfaces

92.8.5 Repair damaged floors/walls and other structural damage

9.2.8.6 Re-examine traffic patterns. Where necessary and feasible, limit traffic

flows (employee and equipment) through the area, restrict forklift truck
movement, redirect high-risk traffic patterns from adjacent areas, etc.

92.8.7 To verify the effectiveness of corrective actions taken, sampling

frequency of these sites will be increased as previously described in
sections 9.2.5to 9.2.7. Document on Form 2-115-P2 Alert/Action and

Positive Result Resample Log. Then resume the regular sampling
frequency.

92.8.8 Tf any of the re-samples do not micet specification, follow procedure
again from the beginning of this section.

o3 Consecutive Alert/ Action Level or Pasitive Results

9 Consecutive Alert/Action Level or positive results may indicate the primary source aL

is a harborage site (where the organism may have been established and multiplying).

9.3.2 Map the contamination sites on a layout of the facility to aid in locating the source oB

of contamination.

9.3.3 Reinforce GMP training and hygienic practices and provide additional attention to
sanitation practices.

43.4 Visnally inspect areas for potential niches. Intensify cleaning activities around these
areas,

9.3.5 Observe handling practices (production, sanitation, maintenance, material handling)
and correct non-hygienic employee practices.

2.3.06 Review equipment cleaning and preventative maintenance protocols and revise if

[SOP

iG.G Issui

iQ]

[Q.2

10.3 eeB seo emM AC

Construction or New Equipment
O4.1 Construction or new equipment installation in the processing areas may affect the
PCS. Assess plant traffic controls, sanitation activities, etc. during construction
activities. Assess envirommental monitoring requirements within protocols initiated
at time of consirtuction or new equipment installation G.e. 1Q/OO/PQ for those
processes},
ng, Reporting, and Piling
Attachment 1 through 2 will be utilized for each sampling plan to execute the
Environmental Monitoring of Air and Surfaces for an entire year.
Document all mutine samples taken and results obtamed on forms D-LES5-F1 Au and
Surface Sampling Log.
All resamples taken, CAPAs, or DEV numbers assigned Gf applicable), and results
obtamed will be documented on form 0-115-F2 Alert/Action and Pasitive Result
Resample Log.
A summary report will be generated of each quarter with testing and trending to
Document Control wrth an issued Report number. Refer to SOP C-105 Protocol and
Report Documentation Requirements. This quarterly review should be documented
within sixty calendar days of the end of each subject quarter.
Quarterly reports will summarize the monitoring data for the quarter and will contain
trend reports for a rolling year. The reports will include:
10.5.1 Summation of the data collected
10.3.2 Evaluation of the adequacy of the current sampling plans
10.5.5 Evaluation of the adequacy of established alert and action limits
10.3.4 All seports will be approved by a minimum of four (4) si gnatures to melude:

[SOP

SOPNo | Rev
Standard Operating Procedure
Page 14 of 26
Environmental Monitoring of Air and Surfaces

10.5.4.) Author

10.5.4.2 QC Laboratory Management

10.5.4.3 Head of Quality or Quality designee outside the QC Laboratory

10.5.4.4 Head of Operations or designee

11.0 Revisions

11.4 Review specifications for alert/action limits annually or as needed.

li.i.) A risk-based unpact assessment should be conducted to understand each process

and identity where microbial contamimation could occur. The level of contral
should be on product-specific characteristics (e.g., dosage form, water activity,

antimicrobial properties} and manufacturing process elements that are more likely
to introduce bioburden or objectionable microorganisms.

Li..2 The level ef potential contamination should be adiusted, with consideration to the
J ~ >
processing conditions withim cach area. These conditions include, but are not limited to,
product's exposure, personne! traffic, material flow, and the effectiveness of cleaning and
sanitization procedures. Example shown below,

Areu Risk Factor | Processing Conditions

Blending Room | High Open product, high personnel traffic

Packaging Line | Medium Product enclosed, moderate traffic

Warehouse Low | No prodact exposure

[SOP

Standard Operating Procedure SOP No Rceove eye| oe
D115 it | Page 1S of 26
Environmental Monitoring of Air and Surfaces
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11.1.3 Once each area has been assessed, alert and action limits will be calculated based
on trend analysis of data collected over the previous calendar year. The microbial

baseline level will be defined using updated historical data to ensure continued
representation of the processes sormal operating range and to reflect any

iL.i.4 The caleulation is performed using the average and the standard deviation of the

analyzed data as follows:

Action Limit = Average + 3 Standard Deviations

{1.2 Adpust sampling plans throughout the year as necessary to accommodate added locations
and new equipment installations,

11.3 Follow SOP C-403 Change Control Procedure to process all revisions made io sampling
plans,

12.0 Documentation Requirements

f2.1 ATP documentation will be distributed and maintained as outlined in SOP €-401

Document Control and SOP C-502 Record Storage, Retention, and Destruction.

]2.2 All decumemation will be completed as outlined in SOP A-106 Documentation
Cruidelines for cGMP Recards.

i3.0 Revision History
Revision Date Description of Chanzes CCR H By
0 O3/04/19 | New procedure. NVA L. McWade

| Added plans for each ream including drains. Added flow
OMOZ/21 | chart for gram stain and additional testing to identify positive CO-2 4-023 G. Shaw
Lipdated numbering of keys. Adjusted eummy room to
quarterly testing scheme,
CCl~2)-0420 G. Show
03/21/22 Added shck pack rooms to schedule, Clarified testing and
CO-22-0086 G. Shaw
aiaps. Slt R&D,

[SOP

“SOP No
Standard Operating Procedure Rev
Page 16 of 26
Environmental Monitering of Air and Surfaces
D-115
O4/28/22 i Annnal recalculation of alert and action Himits, t, Shaw

Kept drains on for temporary alert and action limits. Added
s O9/30/22 | layout and sites for the new warehouse building, meluding CU~22-03 90 r. Shaw
sampling booths.
| Added new testing for gummy lines and assaciated liquid
6. 04a/2n0i/m2 3 | aGInNd paBcAkCKaQsEiInNgG roTOOmTS. s. DeLAlSteetiiec d uUnNnTeEcCeEsSSsAaTrYy contenCONEETE. t. NewINGW CC+- 2A3S- G14Al5as Go.g Syhaw
form D-P15-P3 Guowy Line Air and Surface Sarnpling Log
Added mop sinks and log for all sinks. Adjusted plan to be
7 OTI4 just one that is followed quarterly. Added reference to drain CC-23-63.40 G. Shaw
sampling log. Added documentation requirements. Updated.
format.
| Revised to clarify current practices. Removed pathogen
testing for gummy reoms. Clarified corrective actions. J. Sassman
Added alert and action limits for drains. Added Drain Map.
Revised to reflect current practices. Undated sample plan
testing. Removed reference fo obsolete forms. Added new CC-24-0158
forms D-11S-Fl and D-1 15-23,
Revised to reflect current practices. Updated sample plan
testing. Clarified preliminary procedure for selective
10 09/09/24 pathogen screening. Minor changes on forms D-]1S-F i and
-Lt3-F2, Added new form D-115-F3 Preliminary Pathogen
Screening Log,
deN da 9/2 /2:
t t
Revised io reflect current practices. Updated sample plan
testing, Annual recaloulation of alert and action Hmits.
14.0 Attachments

Idi Attachment | ~ Sample Site Key |

14.2 Attachment 2“”y ~ Quarterly Sampling Plan

.o Attachment 3 ~~ Site Map

4 Attachment 4 —~ Layout for Kitting and Sanipling Booths

Attachment 5 ~ Drain Maps

CONTIDENTIAL: For HBI Ion Labs use only

[SOP

Standard Operating Procedure SOP Ale Rev |
D-115 i | Page Wot
Environmental Monitoring of Air and Surfaces

ATTACHMENT 1 ~ SAMPLE SITE KEY

Week Number
1-12

Repms
B = Blending (Aone 2}

SB = Sampling Booth (Zone 4)

Air Samnle Sites

= Far end of room )esra
L, = Liquids (Zone 2) WC = Walk-in Cooler (Zone 4)
CT = Coating (Zone 2} CR = Cold Room Hone 2
P= Packaging (Zone 2} ER = Locker Room (“one 4)
FP = Final Pack (Zone 3} Ko Kitting Zone 4)
SA = Sanitation (Zone 3) R&D = Research and Development Lab (Zone 4)
R- Right
Surface Sample Sites
6 = Misc or Mix 3 Kettle (Zone 2)
7 = Main Equipment or Mogul Dispenser (Zone 2) 10 = Drain (Zone 2 or Zone 3}
8 = Conveyor or Cooling Tunnel (Zone 2)
Ccumimy Lines
GL2 = Gummy Line 2 GLDRI = Gurumy Line Drying Room |

GL3 = Gumovy Line 3 GLDR2 = Gammy Line Drying Room 2
GL4 = Guomy Line 4/Gummy Line Packaging GLDE3 = Gummy Line Drying Room 3

GLSA = Gummy Line Sanitation

[SOP

Standard Operating Procedure
SOP No
17 | «Page I ofl6 |
Environmental Monitoring of Air and Surfaces D-115

Wi
Wi

LIP S-1/6,7,9(a}
LIF B-1/6,97a,)

w2 GLDRI-1
~GLDR2-1
(a) Liguid Rooms back only get air samphne

P3-1,2,3/6,7,8

SAI-7
BI-1/6.7.9
SAI-8

We B5-1/6,7,9

[SOP

y: Standard Operating Procedure SGP No | Rev
p.115 {1 Page 19 of 26
'‘tt( Environmental Monitoring of Air and Surfaces

ATTACHMENT 2 - QUARTERLY SAMPLING PLAS (CONTINUED)

Ws C1-1/6,7,9 | SAL-10
WS 8 16,7,9- B3

Ws C3-1/6,7,9 oT3

Wé6 : P8-12,5/6,7,8 | CTd

WEG 3 CR-1/6 LSF.B
WE GLDR3 -1 :

W7 GL4 ~ 1,2,3/8 SA2-2

W7 TS-1/6,7,9

WS iE P/6.7,9

“Ws - [34 — 1/6.7,9

[SOP

SOPNo | Rev —
Standard Operating Procedure
pis 6 i Page 20 of 26
':ii
{
Environmental Monitoring of Air and Surfaces
ATTACHMENT 2 —- QUARTERLY SAMPLING PLAN (CONTINUED)

Wo CS- 1/6. 7,9

C6-1/6,7,9
wo
CF-1/6,7,9
CS-1/6,7,9
WY

LR-1/6
SAL-LG
WHO
— SA2-1/6
W10
WO

Wl K1-1/6 (b) |

Wi
Wii K4-1/6 (b)
SB-R-1 (b)
Whi
WIL
WC- 16 (b)
(b}) Sarnpling done at Belcher

SA Mop Sink
2 ~ 1/6,7,9 L. Mop Sink
B3 ~ 1/6,7,9
B4 ~ 1/6,7,9

B6 — 1/6,7

[SOP

Standard Operating Procedure
Page 21 of 26
Environmental Monitering of Air and Surfaces
H
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[SOP

SOP Ne
il Page 22 af 26
D-LIS
Environmental Monitoring of Air and Surfaces
retuen
ealumeie
eeL
ATTACHMENT 4- LAYOUT FOR KITTING AND SAMPLING BOOTHS
Hallway
Sampling Booth - Pot

Kitting #2

Kitting #3

Hallway

Mop Sink

[SOP

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