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Facility ID: 01845PHRMC70FLA
Facility Name and Address: VERANOVA L.P. 70 FLAGSHIP DR NORTH ANDOVER, MA 01845 Parent Company: AHP-VERANOVA LP Industry: Pharmaceutical Preparation Manufacturing (325412) Chemical: Methyl isobutyl ketone 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 |
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: 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. CHEMICALS USED AND THEIR VOLUMES ARE DICTATED BY CLIENTS' PROJECTS AND THEIR SPECIFICATIONS. |
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2017 |
Barriers: B7-Barriers to P2 B7 - No known substitutes or alternative technologies.
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Other Environmental Practices: Energy Recovery - CURRENT JM APPROVED DISPOSAL FACILITIES ATTEMPT TO SEND THIS WASTE FOR ENERGY RECOVERY WHENEVER POSSIBLE. Source Reduction: Source Reduction - IF A CLIENT'S PROCESS ALLOWS, JM WILL SEEK ALTERNATIVE LESS HAZARDOUS CHEMICALS WHEN POSSIBLE. DUE TO FDA CONSTRAINTS AND CLIENT'S APPROVED PROCESSES, SUBSTITUTIONS ARE OFTEN NOT PERMITTED. THE CLIENT HAS DEVELOPED THEIR PRODUCTION PROCESS TO GAIN THE HIGHEST YIELD AND HIGHEST QUALITY. Barriers to P2: B7 - No known substitutes or alternative technologies. - MIBK WAS REQUIRED BY A SPECIFIC PURIFICATION PROCESS CONDUCTED FOR A CLIENT DURING 2017. THIS CLIENT'S PROCESS CONTINUES TO BE CONDUCTED AT JM AND MIBK USE WILL DEPEND ON THE NUMBER OF BATCHES CONTRACTED BY CLIENT. SHOULD CLIENT'S OTHER MANUFACTURERS NOT MEET DEMAND JM WILL BE CONTRACTED FOR ADDITIONAL MANUFACTURING AND HIGHER MIBK USE WILL BE DOCUMENTED. |
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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: 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. |
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2015 |
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: B3 - Concern that product quality may decline as a result of source reduction. - The facility used additional MIBK in 2015 for column chromatography related to purification process for a client specific project. The chromatography process relies on specific solvents which are used based on the client's requirements and the solvent properties which will help purify the materials. |
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2014 |
Other Barriers to Source Reduction - The batch process production methods utilized by JMPS is determined by the clients needs and whether a clients product is approved by FDA. If in the FDA approval process, chemical substitutions are not permitted. This eliminates the ability to substitute less hazardous materials. |
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2013 |
Source Reduction:: W56: Reduced or eliminated use of an organic solvent
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Methods to Identify SR Opportunities: T11: Other
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Source Reduction - The operations team will review the processes and determine which steps may allow for distillate reuse vs. new solvent. Source Reduction - When possible the distillate solvents from a batch process may be reused if they meet the quality specifications. They may be run through the process again. This reduces the amount of virgin solvent needed. Reusing chemicals is not always permitted either due to the established batch record which has been approved by the client and possibly by FDA guidelines. |