TRI Pollution Prevention Report for VERANOVA L.P. and Methanol

Facility ID: 01432PHRMC25PAT

Facility Name and Address:
VERANOVA L.P.
25 PATTON RD
DEVENS, MA 01434

Parent Company: VERANOVA BIDCO L.P.

Industry: Pharmaceutical Preparation Manufacturing (325412)
Chemical: Methanol

Production Related Waste Management for Selected Chemical


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    Waste Management Comparison - 2021



Pollution Prevention Activities for Selected Chemical


Reporting Year Section 8.10: Newly Implemented Source Reduction Activity Section 8.10: Methods to Identify Activity Section 8.11: Optional Pollution Prevention Information*
2019 Source Reduction:: W71: Other cleaning and degreasing modifications
Methods to Identify SR Opportunities: T05: Employee recommendation (independent of a formal company program)
Barriers: B3-Barriers to P2 B3 - Concern that product quality may decline as a result of source reduction.
W71: When possible, methanol will be reused for cleaning processes within campaigns. This may be permitted by the client and when acceptable this can reduce the use of methanol by 1 drum per client's batch.

Source Reduction - Reusing solvents for repeat cleanings was offered by production coordinators and project managers must receive approval from client representatives before proceeding.

Barriers to P2: B3 - Concern that product quality may decline as a result of source reduction. - JM IS A CONTRACT PHARMACEUTICAL MANUFACTURING AND RESEARCH FIRM WHICH MANUFACTURES PRODUCTS ON A BATCH BASIS BY CLIENT. THE CLIENTS PROJECTS DICTATE THE CHEMICALS USED AND THE QUANTITIES. AS THESE PRODUCTS MAY BE IN FDA APPROVAL PROCESS OR ALREADY FDA APPROVED JM HAS LITTLE OPPORTUNITY TO ENCOURAGE LESS HAZARDOUS CHEMICAL SUBSTITUTIONS. WHEN POSSIBLE IN EARLY STAGES OF WORKING WITH NEW CLIENT, JM WILL OFFER TO OPTIMIZE PROCESS WHICHMAY RESULT IN LESS CHEMICALS USED OVERALL BY REDUCING NUMBER OF FILTRATIONS, WASHES, ETC.

2018 Source Reduction:: W71: Other cleaning and degreasing modifications[-0-4%]
Methods to Identify SR Opportunities: T05: Employee recommendation (independent of a formal company program)
W71: When possible, methanol will be reused for cleaning processes within campaigns. This may be permitted by the client and when acceptable this can reduce the use of methanol by 1 drum per client's batch.

Source Reduction - Reusing solvents for repeat cleanings was offered by production coordinators and project managers must receive approval fromclient representatives before proceeding.
2017 Other Barriers to Source Reduction - JM IS A CONTRACT PHARMACEUTICAL MANUFACTURING AND RESEARCH FIRM WHICH MANUFACTURES PRODUCTS ON A BATCH BASIS BY CLIENT. THE CLIENTS PROJECTS DICTATE THE CHEMICALS USED AND THE QUANTITIES. AS THESE PRODUCTS MAY BE IN FDA APPROVAL PROCESS OR ALREADY FDA APPROVED JM HAS LITTLE OPPORTUNITY TO ENCOURAGE LESS HAZARDOUS CHEMICAL SUBSTITUTIONS. WHEN POSSIBLE IN EARLY STAGES OF WORKING WITH NEW CLIENT, JM WILL OFFER TO OPTIMIZE PROCESS WHICH MAY RESULT IN LESS CHEMICALS USED OVERALL BY REDUCING NUMBER OF FILTRATIONS, WASHES, ETC.


Other Environmental Practices: Energy Recovery - JM waste disposal vendors seek energy recovery disposal options whenever possible.

2016 Barriers: B3-Barriers to P2 B3 - Concern that product quality may decline as a result of source reduction.

Barriers to P2: B3 - Concern that product quality may decline as a result of source reduction. - JM is a pharmaceutical contract manufacturing organization that manufactures Active Pharmaceutical Ingredients and intermediates based on clients' project requirements. Depending on whether an API or intermediate is in an FDA approval phase, chemical substitutions will not be permitted by the client. This factors heavily into whether a source reduction activities may be undertaken.

Barriers to P2: B3 - Concern that product quality may decline as a result of source reduction. - Active pharmaceutical ingredients and intermediates are made using the development methods and materials required by the clients. If an API is going through clinical trials or development, clients will not allow chemical substitutions due to concerns regarding any FDA submittals that have been processed or are being processed. Chemical changes may affect the FDA submittal and can result in FDA rejection of a phase 1, 2 or 3 submittal.

2015 Barriers: B3-Barriers to P2 B3 - Concern that product quality may decline as a result of source reduction.

Barriers to P2: B3 - Concern that product quality may decline as a result of source reduction. - Active pharmaceutical ingredients and intermediates are made using the development methods and materials required by the clients. If an API is going through clinical trials or development, clients will not allow chemical substitutions due to concerns regarding any FDA submittals that have been processed or are being processed.

2014 Other Barriers to Source Reduction - The batch process schedule and the clients JMPS is contracted with determine the chemicals used and the chemical amounts required. If a client's product is in the process of FDA approval or has been FDA approved, chemical substitutions cannot be made.

2013 Source Reduction:: W58: Other process modifications
Methods to Identify SR Opportunities: T11: Other
W58: The operations team reviews the processes to determine if there opportunities to reduce or reuse solvents. This is process dependent and must be approved by the clients.

Source Reduction - When possible the distillates from the project may be reused to further process materials. If this can be done it reduces the amount of virgin solvent needed. Distillates may also be used for within campaign cleaning and this negates the need for new solvent. These steps are possible if the process allows for them and if the client is agreeable to them.
2012 Other Barriers to Source Reduction - The particular chemistry performed by the site in the production of client specific compounds requires use of certain solvents. Efforts are made to substitute less hazardous chemicals when possible but this is not feasible in most circumstances.

*Classifications of Optional Pollution Prevention Information shown in brackets are provided by EPA.


TRI Pollution Prevention Glossary

The Waste Management Hierarchy

The waste management hierarchy established by the Pollution Prevention Act (PPA) guides waste generators toward the best options for managing wastes. The preferred option is to prevent pollution at its source, but for waste that is generated, the preferred management methods are recycling, followed by burning for energy recovery, treatment and, as a last resort, disposing of the waste.
  • Source Reduction includes activities that eliminate or reduce the generation of chemical waste.
  • Recycling includes the recovery of a toxic chemical in waste for reuse.
  • Energy Recovery includes the combustion of toxic chemicals in waste to generate heat or electricity.
  • Treatment includes the destruction of a toxic chemical in waste.
  • Disposal or Other Releases includes toxic chemical quantities entering the environment.
The PPA requires facilities to provide the following details about each chemical they report to TRI:
Facilities may also provide optional Pollution Prevention Information describing their source reduction, recycling, or pollution control activities.