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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: Dichloromethane Reports: View TRI Facility profile report for this facility View TRI Form R submissions by this facility |
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Production Related Waste Management for Selected Chemical
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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* |
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2019 |
Source Reduction:: W71: Other cleaning and degreasing modifications
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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, DCM will be reused for cleaning processes within campaigns. This may be permitted by the client and when acceptable this can reduce the use of DCM 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. 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 BASISBY CLIENT. THE CLIENTS PROJECTS DICTATE THE CHEMICALS USED AND THE QUANTITIES. AS THESE PRODUCTS MAY BE IN FDAAPPROVAL PROCESS OR ALREADY FDA APPROVED JM HAS LITTLE OPPORTUNITY TO ENCOURAGE LESS HAZARDOUS CHEMICALSUBSTITUTIONS. 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%]
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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, DCM 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. 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 BASISBY CLIENT. THE CLIENTS PROJECTS DICTATE THE CHEMICALS USED AND THE QUANTITIES. AS THESE PRODUCTS MAY BE IN FDAAPPROVAL PROCESS OR ALREADY FDA APPROVED JM HAS LITTLE OPPORTUNITY TO ENCOURAGE LESS HAZARDOUS CHEMICALSUBSTITUTIONS. 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. |
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. |
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2016 |
Barriers: B3-Barriers to P2 B3 - Concern that product quality may decline as a result of source reduction.
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Barriers to P2 - Due to nature of solvent recycling business, dichloromethane recycling has not been pursued. The cost of new solvents has decreased interest in recycled solvents. Additionally, due to economies of scale JM has not identified a suitable source for recycling methylene chloride. Recyclers prefer to receive tanker quantities vs. drum quantities.
Barriers to P2: B3 - Concern that product quality may decline as a result of source reduction. - JM is a pharmaceutical contract manufacturing firm and chemicals used are determined by client required processes. 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. |
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2015 |
Barriers: B3-Other Environmental Practices B3 - Concern that product quality may decline as a result of source reduction.
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Other Environmental Practices - When the process allows, the used dichloromethane is used for within campaign cleaning. If the used dichloromethane is produced in the chromatography suite, the first pass dichloromethane distillate may be used to unpack the chromatography column instead of using virgin solvent.
Other Environmental Practices: 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. When the process allows, the used dichloromethane is used for within campaign cleaning. If the used dichloromethane is produced in the chromatography suite, the first pass dichloromethane distillate may be used to unpack the chromatography column instead of using virgin solvent. |
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2014 |
Other Barriers to Source Reduction - Batch processes run at JMPS are dictated by the clients needs and the project requirements. If a clients product is in the FDA approval process or has been approved by the FDA chemical substitutions are not permitted. |
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2013 |
Source Reduction:: W58: Other process modifications
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Methods to Identify SR Opportunities: T11: Other
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Source Reduction - The operations team reviews the proceses to determine where there are opportunities to reduce solvent use or reuse solvents. This is process dependent and also involves the clients' approval. Source Reduction - When possible distillates are reused in the process thus saving the need for new solvent. This is only possible during certain processes and if the client allows. Distillates may be used during within campaign cleanings as well saving the need for using new solvents. |
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. |