Improving and Optimizing your Viable Environmental ...€¦ · Improving and Optimizing your Viable...

Improving and Optimizing your Viable Environmental Monitoring Program

Jason WillettMidwest ManagerVeltek Associates, Inc.

U.S. Railroad tracks are 4’ 8.5” in width. That’s a strange number… Where did that specification come from?

Because that was the specific width of the English railroad tracks and the U.S. Railroads were built by English settlers (expatriates). But, why is that so?

Because, in England, the railroads were built by the same people who made the original tramcars. They had used the same gauges as the tramcars, which had that specific spacing. But, why is that so?

Because, the people who built those tramcars used the same tools as they did for building wagons. And the wagon axles had that specific spacing. But, why is that so?

Because, the the old, ragged, roads in England had wheel ruts on the sides of the road. This specific spacing was needed to keep the wagon wheels from maneuvering out of the ruts and breaking on the rough surfaces. But, why is that so?

Because, the roads where originally built by Imperial Rome and those ruts were dug over many years by their chariots. That was the specific width of the chariot wheels. But, why is that so?

The Roman chariots were specifically spaced just wide enough to accommodate the rear ends of two horses.

Where did this Specification Come From?

May 2016 Veltek Associates, Inc. 2

So, the next time you are handed a specification and you are forced to wonder, “What horse’s ass came up with this?”, you may be right!

The response, “We’ve always done it this way”, would be correct as well.

Where did this Specification Come From?


Let’s Start From the Beginning…

Contamination Control is a proven system that prevents external contamination from entering controlled environments

Environmental Monitoring tests that the system you designed is keeping your areas under control

Cleaning and Disinfection corrects the inappropriate introduction of contamination

“System” Components


• Personnel

• Equipment

• Disinfectants and cleaners

• Water

• HVAC

• Manufacturing Processes

Areas of Control Within a Facility


It Is:

• Demonstrates Control of Aseptic Operations

• Identifies problems and trends in process and facilities

• Cleaning and Disinfection corrects the inappropriate introduction of contamination

• Data collection to support root cause analysis of excursions

Is is Not:

• A test for final product release

• An analytical test

• Highly reproducible or recoverable

• Always constant

• Always linked to the “smoking gun” (cause and effect)

• Total picture of control

What is Environmental Monitoring?


Global Regulations, Guidelines and Literature

United States• United States Pharmacopeia 39, <1116> Microbiological Control and Monitoring of Aseptic

Processing Environments• FDA Guidance for Industry, Aseptic Processing, cGMP (October 2004)

Europe• GMP, Manufacture of Sterile Medicinal Products, Annex 1 (October 2009)

World Health Organization• Technical Report 961, Annex 6: GMPs for sterile pharmaceutical products (2011)• Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities - Points to

consider for manufacturers of human vaccines (November 2012)

Japan• Japanese Pharmacopoeia 16 (October 2011) - Microbiological Evaluation of Processing Areas for

Sterile Pharmaceutical Products• PDMA - Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing

(October 2006)

PIC/S• Annex PE009-11: Guide GMP for Medicinal Products (March 2014)

PDA• Technical Report #13 (Revised) Fundamentals of an Environmental Monitoring Program (2014)

Current Documentation


Document How to Determine Locations

EU, WHO Based on formal risk analysis study and the results obtained during room classification and/or clean air devices

PIC/S • Based on a formal risk assessment.• Consider data obtained during room classification and previous monitoring data• Critical locations should be covered

FDA Guidance • Representative locations• Locations posing the most microbiological risk to the product• Locations where significant activity or product exposure occurs during production

USP • Locations considered should include those in proximity of the exposed product, containers, closures, and product contact surfaces

• Best selected with consideration of human activity during operations• Evaluate impact of personnel movement and work within the area• Entry points and areas within and around doors and airlocks• The most likely route of contamination is airborne, so the samples most critical to risk

assessment are those that relate to airborne contamination near exposed sterile materials.

Japanese Guidance

• Size of working area, scope of operations and process flow of materials and products• Potential product contamination

JapanesePharmacopoeia

Not Specified

Determination of Sample Locations


Document Frequency

EU, WHO & PIC/S

The Grade A zone should be monitored at a frequency and sample size such that all interventions, transient events and any system deterioration would be captured and alarms triggered if alert limits are exceeded.

FDA Guidance

Based upon the relationship to the operation performed… Sample sizes should be sufficient to optimize detection of environmental contaminants at levels that might be expected in a given clean area

USP

Suggested Frequency of Sampling for Aseptic Processing AreasSampling Area/Location Frequency of Sampling

Clean Room/RABSCritical zone (ISO 5 or better)

Active air sampling Each operational shiftSurface monitoring At the end of the operation

Aseptic area adjacent critical zoneAll sampling Each operating shift

Other nonadjacent aseptic areasAll sampling Once per day

IsolatorsCritical zone (ISO 5 or better)

Active air sampling Once per daySurface monitoring At the end of the operation

Non-aseptic areas surrounding the isolatorAll sampling Once per Month

Viable Monitoring Frequency


Document Frequency

Japanese Guidance

To be determined in accordance to the air cleanliness level required for individual working areas. For example:


Grade Microorganisms in air

Surfaces Particles

A & B Every working shift After completion of processing

Continuously

C & D Twice a week Twice a week Twice a week

Processing area Frequency of monitoring

Critical area (Grade A) Each Shift

Clean area adjacent to critical area (Grade B) Each Shift

Other clean areas (Grade C, D)• Potential product/container contact areas• Non-product/container contact areas

Twice a weekOnce a week

Viable Monitoring Frequency, continued



EU, WHO, PIC/S • Air: Settle plates and volumetric air• Surfaces: (Examples) swabs and contact plates

FDA Guidance • Air: Active device, optional settling plates• Surfaces: Touch plates, swabs and contact plates

USP • Air: Choose from a variety of active samplers, settle plates• Surface: contact plates or swabbing

Japanese Guidance • Air: Settle plates, impact and filtration methods• Surfaces: contact plate or swabbing


• Air: Settle plates, impact and filtration methods• Surfaces: contact plates or swabs

Viable Sampling Methods


Recommended Limits for Microbial Contamination*a

Grade Air Sample -CFU/m3

90mm Settle Plates -CFU/4 Hours *b

55mm Contact Plates - CFU/Plate

5 Fingers Glove Print -CFU/Glove

A <1 <1 <1 <1

B 10 5 5 5

C 100 50 25 -

D 200 100 50 -

a. These are average values.b. Individual settle plates may be exposed for less than 4 hours.

Viable Limits – EU, WHO, PIC/S & Japan


TABLE 1 - Air Classifications a

Clean Area Classification

(0.5 μm particles/ft3)

ISO Designation b

> 0.5 μm particles/m3

Microbiological Active Air Action Levels c

(CFU/m3 )

Microbiological Settling PlatesAction Levels c,d

(diam. 90mm; CFU/4 hours)

100 5 3,520 1 e 1 e

1,000 6 35,200 7 3

10,000 7 352,000 10 5

100,000 8 3,520,000 100 50

a. All classifications based on data measured in the vicinity of exposed materials/articles during periods of activity.

b. ISO 14644-1 designations provide uniform particle concentration values for cleanrooms in multiple industries. An ISO 5 particle concentration is equal to Class 100 and approximately equals EU Grade A.

c. Values represent recommended levels of environmental quality. You may find it appropriate to establish alternate microbiological action levels due to the nature of the operation or method of analysis.

d. The additional use of settling plates is optional. e. Samples from Class 100 (ISO 5) environments should normally yield no microbiological contaminants.

Viable Limits – FDA (2004 GMP)


Table 4: Recommended limits for environmental microorganisms*1

CFU on a surfaceInstruments/Facilities Gloves

GradeAirborne

microorganisms*2

(CFU/m3)

Minimum air sample(m3) (CFU/24-30 cm2)*3

A <1 0.5 <1 <1

B 10 0.5 5 5

C 100 0.2 25 -

D 200 0.2 50 -

*1 Maximum acceptable average numbers of microorganisms under each condition.*2 These values are by using a slit sampler or equivalent.*3 Viable microbe cell number per contact plate (5.4 - 6.2 cm in diameter). When swabbing is used in sampling, the number of microorganisms is calculated per 25 cm2. For gloves, usually, put their all fingers on the plate.

Viable Limits – Japanese Pharmacopoeia


Microbial Control Parameters (Incident Rate):

Suggested Initial Contamination Recovery Rates in Aseptic Environments*

Room Classification Active Air Sample (%)

Settle Plate (9 cm) 4 h Exposure (%)

Contact Plate or Swab (%)

Glove or Garment (%)

Isolator/Closed RABS (ISO 5 or better) <0.1 <0.1 <0.1 <0.1

ISO 5 <1 <1 <1 <1ISO 6 <3 <3 <3 <3ISO 7 <5 <5 <5 <5ISO 8 <10 <10 <10 <10

* All operators are aseptically gowned in these environments (with the exception of background environments for isolators). These recommendations do not apply to production areas for non-sterile products or other classified environments in which fully aseptic gowns are not donned.

Viable Limits - United States Pharmacopoeia



EU, WHO & PIC/S Not Specified

FDA Guidance A compressed gas should be of appropriate purity (e.g., free from oil) and its microbiological and particle quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced.

USP Microbial monitoring of manufacturing clean rooms, RABS, and isolators should include compressed gases, surfaces, room or enclosure air, and any other materials and equipment that might produce a risk of contamination.

Japanese Guidance Environmental monitoring targets should also include … compressed air or gas that comes in contact with the environment and equipment.

Japanese Pharmacopoeia Not Specified

Viable Monitoring of Compressed Gases


ISO 14644

• Covers the classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles (has nothing to do with viable)

ISO 14698• Establishes the principles and basic methodology of a formal system of

biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose.

• Annex B: This annex describes a technique for determining the collection efficiency of samplers used for counting airborne microbes. Manufacturers or third-party testing organizations will usually perform this evaluation (this has no bearing on compressed gas/air). This is the unit’s VALIDATION.

ISO 8573-7• Specifies a test method for distinguishing viable, colony-forming, microbiological

organisms from other solid particles which may be present in compressed air.• A quantitative assessment MAY be made using the method given in Annex B (Slit to

Agar)

ISO Regulations – Misinterpretation?


An analysis provided by the manufacturer of the device (according to ISO 14698)

An on-site comparative analysis (side by side) of the current device against the new device being implemented (e.g. Performance Qualification)

Trending/performance of the newly implemented device (e.g. Performance Qualification)

A study assuring that desiccation of the nutrient media does not occur during the length of the sample and subsequent incubation period.

An Installation Qualification and Operational Qualification need to be completed prior to implementation.

Qualification of Viable Air Samplers


Types of Viable Air Samplers

Sieve Impaction (many devices) Surface Air Sampler (SAS) Centrifugal Air Sampler (RCS) Slit to Agar Sampler (many devices) Sterilizable Microbial Atrium (SMA) Gelatin Filter Air Sampler (MD-80)

What makes them all different?

Portable Viable Air Samplers


http://www.google.com/url?sa=i&rct=j&q=environmental+monitoring+microbial&source=images&cd=&cad=rja&docid=TVkCjYPMzGsBcM&tbnid=w-3YGkOH5iW_VM:&ved=0CAUQjRw&url=http://www.envirotech-online.com/news/environmental-laboratory/7/merck_millipore_sa/reliable_and_convenient_active_air_monitoring_for_microbes/21110/&ei=T90wUbS8EtOp0AG5w4HgCQ&psig=AFQjCNEnI-YxKL5Vn0H4HBuaBv41Y09xRg&ust=1362242277454692

http://www.google.com/url?sa=i&rct=j&q=environmental+monitoring+microbial&source=images&cd=&cad=rja&docid=TVkCjYPMzGsBcM&tbnid=w-3YGkOH5iW_VM:&ved=0CAUQjRw&url=http://www.envirotech-online.com/news/environmental-laboratory/7/merck_millipore_sa/reliable_and_convenient_active_air_monitoring_for_microbes/21110/&ei=T90wUbS8EtOp0AG5w4HgCQ&psig=AFQjCNEnI-YxKL5Vn0H4HBuaBv41Y09xRg&ust=1362242277454692

This method is still widely used as a simple and inexpensive way to qualitatively assess the environments over prolonged exposure times. Published data indicate that settling plates, when exposed for 4 – 5 hour periods, can provide a limit of detection for a suitable evaluation of the aseptic environment. Settling plates may be particularly useful in critical areas where active sampling could be intrusive and a hazard to the aseptic operation.

One of the major drawbacks of most mechanical air samplers is the limited sample size of air being tested.

Settle (Passive) Plates


Isolator/RABS/Fixed Location Air Samplers


Similar to their portable versions, however, these are designed so that the moving/active components (pumps, vacuums, electronics, etc.) are physically located outside of the barrier or room.

It is generally NOT recommended to use a portable device inside an ISO 5 area for the following reasons: Portable devices are NOT able to be fully sterilized Portable devices generate particles Portable devices disrupt unidirectional airflow

Viable Compressed Gas Samplers

25May 2016 Veltek Associates, Inc.

Rapid Technologies for Viable Air Sampling


Examples of Installed HMI/TouchScreens


Examples of Fixed Sample Locations


Ability to Monitor/Control from Outside ISO 5


Document Microorganism Incubation Conditions

EU, WHO, PIC/S Not Described Not Described

FDA Guidance Fungi (yeast & molds) as well as bacteria

TABC: 30 - 35°C for 48 - 72 HoursTCYM: 20 - 25°C for 5 – 7 Days

USP Bacteria, yeast, and molds. Strict anaerobes not performed, but micro-aerophilic organisms may be sampled for, if warranted.

Time and incubation are set once appropriate media is determined.SCDM (TSA): 20 - 35°C for not less than 72 hours (longer for slow growers)

Japanese Guidance

Aerobic Bacteria, fungi (yeast & molds) & anaerobic bacteria

The incubation condition of the medium should be suitable for growth of the targetmicroorganisms (Huh?)

Japanese Pharmacopoeia

Aerobes, Yeast, fungi & Anaerobes (not typically targeted)

Aerobes: 30 - 35°C for more than 5 daysFungi: 20 - 25°C for more than 5 daysAnaerobes: 30 - 35°C for more than 5 daysIf SCDM is used for TVC, then 25 - 30°C for more than 5 days

Media Selection & Incubation


First incubate at 20-25°C temperature for 72 hours for fungal growth and then same plates transferred to 30-35°C for further 48 hours for bacterial growth. – Favors Yeast & Molds

First incubate at 30-35°C temperature for 48 hours for bacterial growth and then same plates transferred to 20-25°C for further 72 hours for fungal growth. – Favors Gram Positive Cocci

Let’s Apply What We Now Know…


You currently manufacture a single batch, spanning an 8 hour operating shift

Air Sampler “A” - operates at 180 L/Min and samples a cubic meter in 5.5 minutes.

Air Sampler “B” - operates at 100 L/Min and can utilize an “interval sampling” mode.

Air Sampler “C” - operates at 28.3 L/Min and can actively sample for 3 - 4 hours on a single plate.

How many plates do you need to sufficiently cover your production, how many will you bring into the APA at a time?

How many interventions have you planned for plate changes (do you stop)?

How many plates will you utilize (and subsequently have to review)?

What did you potentially miss between samples/sampling?

What We May Have Missed


Multiple air samples can lead to false positives (operator/analyst contamination), mishandled plates & more laboratory work.

Non-sampling time between plate changes (or during “passive” state of of interval sampling) can result in missed contamination events.

Establishing and Executing

Alert & Action Levels


EU, WHO & PIC/S Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action.

FDA Guidance Based on :• The relationship of the sampled location to the operation• The need to maintain adequate microbiological control throughout the entire

sterile manufacturing facility• Historical databases, media fills, cleanroom qualification and sanitization studies

USP • Alert Levels: Not Specified• Action levels: Should be based on empirical process capability

Japanese Guidance • Action level by referring to data contained in monitoring frequency table.• Alert level based on results of a PQ test


An environmental control program document is prepared for each area used for the processing of sterile pharmaceutical products. The procedures in the document include: … 5) alert and action levels, and 6) actions to be taken when specified levels are exceeded.

Establishing Alert & Action Levels


Establishing Alert & Action Levels


0

20

40

60

80

100

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Nu

mb

er

G+C G+R G-R YST Mold

Executing Alert & Action Levels


• Regulations require: Immediate follow-up Identification of microorganisms Corrective actions/preventive

actions (CAPAS) if appropriate

• Indicates potential deviation from normal operational conditions

• Document and follow-up• Additional or modified sample plan• Designed to allow appropriate

capability of reaction before reaching Action level

• No actions required

Identification of Microorganisms

Document Microorganism

EU, WHO, PIC/S, Japanese GMP & Japanese Pharmacopoeia

Not Described

FDA Guidance • Monitoring of critical and immediately surrounding clean areas as well as personnel should include routine identification of microorganisms to the species (or, where appropriate, genus) level

• Establishing an adequate program for differentiating microorganisms in the lesser-controlled environments, such as Class 100,000 (ISO 8), can often be instrumental in detecting such trends (migration of microorganisms into clean areas)

• At minimum, the program should require species (or, where appropriate, genus) identification of microorganisms in these ancillary environments at frequent intervals to establish a valid, current database of contaminants present in the facility during processing (and to demonstrate that cleaning and sanitization procedures continue to be effective)

USP • A successful environmental control program includes an appropriate level of identification of the flora obtained by sampling.

• A knowledge of the flora in controlled environments aids in determining the usual microbial flora anticipated for the facility and in evaluating the effectiveness of the cleaning and sanitization procedures, methods, agents and recovery methods.

• The information gathered by an identification program can be useful in the investigation of the source of contamination, especially when recommended detection frequencies are exceeded.





Staphylococcus luteus, 9.6%

Staphylococcus epidermidis, 8.7%

Staphylococcus hominis, 5.6%

Bacillus cereus, 4.3%

Corynebacterium tuberculostearicum

2.9%

Staphylococcus capitis, 2.8% Bacillus pumilus,

2.7%Staphylococcus warneri, 2.5%

Bacillus subtilis, 2.4%

Staphylococcus haemolyticus, 2.2%

Ralstonia pikettii, 1.7%

Paenubacillus glucanolyticus,

1.5%Bacillus megaterium, 1.5%

Proprionibacterium acnes, 1.0%

Bacillus licheniformis, 0.9%

Source: Bacteria Most Often Submitted for Identification Testing During 2010, Barry A. Friedman, posted May 17, 2011

Distribution of Microorganisms


People

Air/Soil

Water/Liquid



Biochemical (Selective Assays)

Gram Stain

Coagulase Test Oxidase Test

Catalase Test

Indole Test


Veltek Associates, Inc. 42

Phenotypic Identification (incorporates reactions to different chemicals or different biochemical markers)

BD BBL™ Enterotube™ II

BioMerieux API® Strips

BD BBL™ Crystal™ ID Panels

42



Phenotypic Identification - continued

Biolog GEN III OmniLog ID® System BioMerieux Vitek® 2 System



Genotypic Identification (based on gene sequencing, 16S rRNA gene)

DuPont RiboPrinter®

Thermo Fisher Scientific MicroSeq®



Proteotypic (MALDI-TOF): Spectral analysis based on ribosomal protein expression

BioMerieux Vitek® MS System Bruker MALDI Biotyper



Fatty Acid Analysis/GC Optical/Raman Spectroscopy

Midi Sherlock Q-FAME™

Batelle REBS™

Viable Monitoring of Surfaces

Irregular Surfaces

Residues

Particulate and Viable particulates

All may complicate monitoring and disinfection

Different Surface Types


Contact plates (RODAC) and swabs

Contact Plate and Swab recovery studies

Contact plates can offer “better recovery” than swabs and utilized more often (where surface and location permits)

Flocked swabs offer “better recovery” than spun/cotton swabs due to physical composition

Rinse samples can be performed on interior surfaces of kettles and tanks using membrane filtration and sterile water (or Ringer’s, etc).

Sampling done on equipment, work surfaces, floors, walls and product contact surfaces after production is complete

Sampling Methods


http://www.google.com/url?sa=i&source=images&cd=&cad=rja&docid=DHH_Kl4ImXo1KM&tbnid=eTDluYstsc6naM:&ved=0CAgQjRwwAA&url=http://www.impactednurse.com/?p=1195&ei=eOkwUeq5BY220AGX3ICACA&psig=AFQjCNFFvdpeHk_7WSBm0ujqkK9c6vgjSg&ust=1362246392133621

http://www.google.com/url?sa=i&source=images&cd=&cad=rja&docid=DHH_Kl4ImXo1KM&tbnid=eTDluYstsc6naM:&ved=0CAgQjRwwAA&url=http://www.impactednurse.com/?p=1195&ei=eOkwUeq5BY220AGX3ICACA&psig=AFQjCNFFvdpeHk_7WSBm0ujqkK9c6vgjSg&ust=1362246392133621

Viable Monitoring of Personnel

Personnel Monitoring: Routine during production

Gloved fingers: underside where contaminants are most likely

Critical gown sites for aseptic operations Contact plate testing of people leaving/exiting

area Routine failures on a person requires a corrective

action (re-training and/or re-qualification)

Gown Training Certification Surface sampling of gown at key garment

locations Personnel MUST participate in a media challenge

at least once annually if they will be filling aseptic product

Viable Monitoring of Personnel


Set strict limits for qualification

Remove those who fail and retrain them

Testing needs to be done by Quality. They should not qualify themselves

Determine Qualification Test locations (8) Hood, goggles, mask, zipper, sleeves, hands (both),

thighs

Re-qualify on an annual basis

Gowning Qualification


Viable Monitoring of Water Systems

Water Sampler Collection & Hold Time


Sample Collection and Testing

After validation of controlled state

Samples should be taken from holding

and distribution system to assess microbiological quality for its intended use

Collect samples consistent with manufacturing

practices

If manufacturing flushes use points

prior to use, collect samples using same

flush cycle

Sample through hoses (not directly

from the tap) if manufacturing requires use of

hoses

Sample locations

Chosen to demonstrate

microbiological quality throughout

the distribution system

Test as soon as possible after collection

If not possible, refrigerate samples

at 2 - 8°C upon receipt in the

laboratory

Time between collection and

examination ≤ 24 hours.

Microbial Monitoring/Testing of Water


Manual Filtration EMD Millipore – Milliflex®Azbil BioVigilant IMD-W™

Mettler-Toledo 7000RMSEMD Millipore –

Milliflex® Quantum BioMerieux ScanRDI™

Cleaning & Disinfection

Sanitizers

• Reduce some level of microbial contamination; least effective agents• Examples: Isopropyl alcohol (70% IPA), and Ethyl alcohol (62% EtOH)

Disinfectants

• Reduce higher levels of vegetative microorganisms than sanitizers depending on the strength and contact time

• Examples: Quaternary Ammonium compounds, Phenolics

Sporicides

• Effective against all microorganisms provided the wetted contact time is achieved

• Examples: Sodium hypochlorite, Hydrogen peroxide/Peracetic acid, Hydrogen peroxide (6% or greater)

Chemical Selection


Cleaning and Disinfection address mistakes in the Contamination Control System

If done appropriately, it cleans particulates and microbes that have been allowed to enter the controlled area

It does not have any preventive capabilities. It cleans or kills what exists but does not prevent the introduction of particulates and microbes, nor their growth.

Too many times disinfection is considered a preventive measure. It is not.

Cleaning & Disinfection Program


Proper cleaning is critical for effective disinfection Would you disinfect without brushing or

cleaning the surface?

Cleaning versus Disinfection


http://www.google.com/url?sa=i&rct=j&q=toothbrush&source=images&cd=&cad=rja&docid=-AMQOM_o2579TM&tbnid=5mvC5egWX6ySNM:&ved=0CAUQjRw&url=http://www.mylot.com/w/image/2020668.aspx&ei=p_IwUaTILo260QHF5oBg&bvm=bv.43148975,d.dmQ&psig=AFQjCNH12mkWrxNxAl_lbZfFPYYHqNavJw&ust=1362248724452481

http://www.google.com/url?sa=i&rct=j&q=toothbrush&source=images&cd=&cad=rja&docid=-AMQOM_o2579TM&tbnid=5mvC5egWX6ySNM:&ved=0CAUQjRw&url=http://www.mylot.com/w/image/2020668.aspx&ei=p_IwUaTILo260QHF5oBg&bvm=bv.43148975,d.dmQ&psig=AFQjCNH12mkWrxNxAl_lbZfFPYYHqNavJw&ust=1362248724452481

http://www.google.com/url?sa=i&rct=j&q=plus+sign+clipart&source=images&cd=&cad=rja&docid=Ed4I74TdwStdxM&tbnid=-DnNXsw-9z0PZM:&ved=0CAUQjRw&url=http://www.clker.com/clipart-3586.html&ei=KPQwUf6OAqin0AHSsICYAQ&psig=AFQjCNEEpinaBmA4pHg4-q1fECCuTHORUQ&ust=1362249122261653

http://www.google.com/url?sa=i&rct=j&q=plus+sign+clipart&source=images&cd=&cad=rja&docid=Ed4I74TdwStdxM&tbnid=-DnNXsw-9z0PZM:&ved=0CAUQjRw&url=http://www.clker.com/clipart-3586.html&ei=KPQwUf6OAqin0AHSsICYAQ&psig=AFQjCNEEpinaBmA4pHg4-q1fECCuTHORUQ&ust=1362249122261653

1.Control What

Enters the Environment

3.Validate disinfectants and

disinfection system in conjunction with cleaning

and disinfection SOP’s

4.Assure

appropriate application and

test again

2.Test the

environment and address the

contamination

The “System” is a Cycle


In Conclusion…


Understand Environmental Monitoring because it can be a very unique and daunting task

The guidelines are just that, guidelines. Establish a well-justified and validated program that works for you and meets the various global recommendations

A good EM program also controls the introduction of contamination

Cleaning and disinfection are critical aspects to contamination control

Monitoring systems should not affect final product

62

Any Questions?

May 2016 Veltek Associates, Inc.

Improving and Optimizing your Viable Environmental ...€¦ · Improving and Optimizing your Viable...

Documents

Transcript of Improving and Optimizing your Viable Environmental ...€¦ · Improving and Optimizing your Viable...