PSCIPHARMACEUT ICAL SUPPLY CHAIN INIT IAT IVE

The Pharmaceutical Supply Chain Initiative

6 HSE Lessons Learned

Presented by Shelly Shope

Elanco Animal Health Division

Eli Lilly and Company

Compiled by:

PSCI Capability Committee

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCIElanco / Lilly Experience

• Longstanding members of PSCI

• Formal Supply Chain HSE program –published in Lilly.com

• Risk Ranking Process for who to visit – API and Highly Potent Sites

are top of the list

• Impact of Elanco Animal Health growth through acquisitions – many

new supply chains to assess

• Staff - Internal HSE Professionals who do assessments and oversee

gap closure. Our goal – improve building HSE into the RFP and

technical transfer process.

– Elanco typically conducts high risk assessments with 2 people for 1-2 days; local

consultant may be second assessor

– Elanco current assessment scope is HSE

– Elanco performs about 50 HSE external visits/year

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCI

Lesson #1 – Clear PSCI Expectations!

• PSCI Companies typically will place language in their supplier

contracts related to the following:

– Suppliers will comply with local regulations

– Suppliers will follow the PSCI principles

– Suppliers will allow on-site assessments to verify adherences to PSCI

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCI

Lesson #1 – Clear PSCI Expectations!

• Where do we see issues

Suppliers will comply with local regulations

PERMITTING & Waste Handling Compliance; Understaffed HSE functions who don’t know regulations

Suppliers will follow the PSCI principles

Who sees the contract and is agreeing to these Principles? Too often the assessment is the first time the company reads the PSCI principles.

Suppliers will allow on-site assessments to verify adherences to PSCI

During assessment supplier learns that ACTUAL PRACTICES are more important to PSCI companies than HSE Documentation. We trust but need to verify.

We MUST tour.

Original contract terms were set by a previous company – HSE may not have been involved.

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCIClarity on Compliance / Permits

• The Right to Operate is not taken for granted. It is unacceptable to operate without required

permits. The permit application and environmental assessments must be submitted in a timely

fashion.

• It is unacceptable to knowingly exceed permits or knowingly work without required permits, even

if local regulator verbally approves and says it is OK.

• Waste must be disposed of following regulations – no unlawful burial on site or sending to

unapproved treatment sites. On site waste treatment facilities/processes cannot be bypassed.

• Sites must operate in the boundaries of their capacities for permits and waste – mass balance

checks are necessary to understand conformance during site visits.

• RECOMMENDATION: Do your own self-assessment on these points. Walk the entire site

and watch for “practice matching procedure”. Require clear understanding of permitting

and site capacities. Don’t wait for a PSCI assessment to understand your state of

compliance. Challenges in permitting need to be openly discussed with your PSCI

partner.

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCILesson #2 –Do we agree on Hazards of API?

and Controls Needed?

• API Supplier – Generic

• API Supplier –

Proprietary Chemistry

as Contract

Manufacturer

• Drug Product Pharma

Company

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Differing Data Sets & Handling

Expectations

Most common differences are Industrial Hygiene,

Combustible Dust, Process Safety, and

Environmental Fate

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCIAPIs are not Nuisance Dust

INDUSTRIAL HYGIENE / WORKER EXPOSURE

• RED FLAG – SDS do not agree on Exposure Limit

• We know APIs do not have regulatory exposure limits – PSCI companies

DO NOT treat APIs as NUSIANCE DUST. Agree on the required

exposure limit and control banding. If none exists – establish one.

• API Chemical companies for Pharma MUST have internal processes for

setting final API and intermediate control banding and implementing

those practices.

• Industrial hygiene workplace monitoring needs to CONFIRM your

strategy is working, especially when exposure limits are low and PPE in

use is very minimal. No data is a RED FLAG.

• IH Capability in some parts of the world is a challenge. We typically

encourage our partners to hire consultants.

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCIBanding Exercise – What Mass can your eye no

longer see?

Band

Range

Mass Inhaled

over 8hr day

10,000 g/m3 4% sugar pack

1,000 g/m3 0.4% sugar pack

100 g/m3 0.04% sugar pack

10 g/m3 0.004% sugar pack

1 g/m3 0.0004% sugar pack

0.1 g/m3 0.00004% sugar pack

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Average worker breathes about 17

M3 in a workday

Photo from web reference “IP Powertools –

Understanding the OSHA Silica PEL”

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCINot all respirators are the same!!

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Source - Wikipedia

Am I a

respirator?

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCICase Study….potent steroid

• API manufacturer of Generic material did not set their own limits but found a limit

on the web from another company and used it. No process for routine review or

looking at new data.

• Elanco limit was 500X times lower. Data exchange revealed similar thought

process on setting limits but different toxicology data was being used. Elanco

process allows for updating when new data available. End Result – companies

aligned within 5X on OEL accounting for different safety margin practices.

• Company had no workplace monitoring data to verify they were meeting their

previous limit or the new limit. API company asked to immediately upgrade from

dust masks and install better controls. API manufacturer collected IH data to verify

their final PPE/engineering was protective. Engineering controls were implemented

in a very focused way reducing costs. Company applying approach to all their

chemical manufacturing.

• DATA IS YOUR FRIEND. IN absence – default to more protective PPE.

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCILot’s of Banding and Control information

available in the literature and on PSCI website

• Risk banding relating to explosive events, radiation, lasers, and biological agents (1970’s/80’s)

• Pharmaceutical industry initiated exposure control characterization (1980’s/90’s)

• Chemical Industries Association (CIA) guidelines for safe handling of colorants (1993)

• Association of the British Pharma Industry (ABPI) first established formal occupational exposure bands (mid 1990’s)

• CIA guidelines for Chemical Hazardous Information and Packaging (CHIP) utilized risk phrases and control levels (1997)

• UK COSHH: Control of Substances Hazardous to Health (1998)– Probably the most developed model for control banding

• International Control Banding Workshops (2002/04/05)• ILO-OSHA toolkit (2006)• Nanotechnology Control Banding initiatives (2008/09)

• PSCI website – type in “IH, Banding, or Containment” on the resource link

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCILesson #3: What does Pharmaceuticals in the

Environment (PIE) mean?

• API levels must be controlled in waste streams that enter the public water systems.

• Pharma companies do not make the assumption that waste pretreatment at the site

plant or in the city system can remove the API.

– PNEC values are agreed on levels that are safe for acute and chronic toxicity

protection to marine life & drinking water safety.

– Mass Balance and/or effluent testing data is needed to support strategy used

• For this key technical topic – Webinar learning seminars are available on the PSCI

web site.

• BOTTOM LINE – align expectations for the API under contract and demonstrate to

the PSCI member companies your own approach to protecting when PNEC values

don’t exist.

• New PSCI Learning – focus equally on what bypasses the waste treatment path

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCIPIE: Stormwater and Groundwater ProtectionElanco/Lilly current focus

Look beyond the Wastewater Pre-Treatment Plant. Zero Discharge claim may be

misleading…

• Red Flags:

– Mass Balance exceeds reported waste levels

– Sheen/strong smell on storm water outfall

– Facility/equipment cleaning water going out the building to ground

– Wastewater equipment overflowing to ground

– Concrete containment pits with open holes, no pump out process

– Large quantities of chemicals stored on bare ground – visible signs of historical leak or

pressurization of drums that could leak

– Waste storage “boneyard” on the site – process for ensuring ONLY empty/clean

containers get there

– Waste sampling streams that allow for bypass of waste treatment system during flooding

– Discharge pipes not connected

– Open storage of hazardous waste sludge or ash in areas subject to rainfall

– No containment prevention system for firewater or spills before releasing to the storm

water

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCI

Occasionally it doesn’t take much to see the gaps

• Scrubber treatment in a 55 gallon drum venting to the room toxic gases

where tour group walks

• API solvent wet cake handling in room with no local exhaust, grounding,

bonding or electrical safety features – minimal to no PPE in use.

• Extremely heavy dust build-up around equipment

• Blank look when you ask about scrubber capacities

• Local exhaust systems which don’t work or not present

• Unwillingness to show the process while running or ‘unloading/cleaning’

• Equipment in room with evidence of past fires – discussion of investigation

and root cause /remediation are troublesome

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Companies with strong PSM programs are generally pleased to show their

programs and successes!

Lessons Learned #4: Define what

you mean by Process Safety?

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCISO …what do we mean by PSM?PSCI Member Example:Eli Lilly Company - Process Safety Management Program

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCI

+

Process Safety Management

Start at Initial Safe Conditions

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Look at the PHA/HazOp Scope and Detail – did it include the chemistry? Is

the equipment analysis actually on the equipment set in use? NO Generic

PHAs.

Look at the What If/Failure Losses – did they really understand impact of failure

and safe operating limits for the process? Do they believe they can fail?

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCISO …what do we mean by PSM?

PSCI Member Example:Eli Lilly Company - Process Safety Management Program

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCILessons Learned #5: Is my

dust Combustible?

Combustible Dust

• MOST COMMON REPLY during assessments – we have no combustible dusts

• Milling, drying, LEV systems, dust collectors, feed blending are common unit operations

where we have these discussions. Often larger gaps at Drug Product vs API but not

always. Scenario – walkthrough shows milling with no inerting or grounding/bonding. PSCI

question – what data do you have that this is safe?

• Definitions for combustible dust are confusing, handling guides often don’t exist

• Minimum Ignition Energy Testing data, particle size, along with KST data for explosion

potential are essential data for planning design and pressure relief.

• Grain / Feed Mills are often where we get very surprised to see lack of knowledge.

• RECOMMEND combustible dust assessment for facility and products – agree on where in

your process to test and test methods.

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCILesson #6 – Safety/Compliance Culture lacks

accountability

• Capable company without strong accountability processes:

– Case Example: Company does central written programs for all their sites – they are technically

very good. They are verified to be the need and/or practice locally.

– BUT - SOPs and instructions posted in work area do NOT match what PPE is available or how

chemicals are being stored.

– Case example – air supplied respirator for trucker unloading. Site took 1 day to find respirator to

demonstrate and then no hose on site reached the truck unloading station. Even using “new”

SOP operators failed to follow each step.

– It is critical to understand that the company knows their risks and how the work is being done

when no-one is looking. Some companies may need a stronger self-auditing portion of their HSE

programs.

– If something as easy as right PPE for job isn’t right, how can more technical PSM, IH, and

environmental programs be in control.

– ACTION: Ensure instructions are right for the job and workers equipped with the

safeguards you believe necessary to protect them.

• Company who doesn’t realize their lack of capability. Solution: Build

capability using experts…don’t try and go it alone..P S C I A u d i t o r T r a i n i n g | M a y 2 0 1 5 20

PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCICLEAR EXPECTATION on API + PSCI Tools =

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PHARMACEUTICAL

SUPPLY CHAIN

INITIATIVE

PSCI

Questions? Resources?

• Thank you

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