{"operation":"document","citation":"15-0102","title":"Mallinckrodt Pharmaceuticals, formally Ikaria, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2015-12-08","effective_on":null,"summary":"15-0102 response to Mallinckrodt Pharmaceuticals, formally Ikaria, Inc. concerning 173.301, 173.302.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0102.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0102.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0102","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/150102.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMaterials Safety\nPipeline and Hazardous\nAdministration\nDEC 0 8 2015\nMr. Juan Miró\nProject Manager, Engineering Department\nMallinckrodt Pharmaceuticals, formally Ikaria, Inc.\n1060 Allendale Dr.\nPort Allen, LA 70767\nReference No. 15-0102\nDear Mr. Miró:\nThis is response to your May 22, 2015 e-mail requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to filling Department of\nTransportation (DOT) specification cylinders. In your e-mail, you ask whether it is\npermissible to overfill a cylinder by 350 psia during the filling process to compensate for\nlosing 350 psia when detaching the cylinder from the gas transfer system. The final pressure\nafter the cylinder is ejected from the filling nozzle is below the marked service pressure.\nThe filling of the cylinder must comply with the applicable requirements in Part 173 Subpart\nG of the HMR. This subpart does not address the variation in pressure during the filling\nprocess. Section 173.301a(c) states that when offered for transportation, the pressure in a\ncylinder at 21 °C (70 °F) must not exceed the service pressure for which the cylinder is\nmarked or designated, except as provided in § 173.302a(b) of the HMR. Except as otherwise\nprovided in § 173.30la(d), the pressure in a cylinder may not exceed 5/4 times the service\npressure at 55 °C (131 °F) when the cylinder is offered for transportation. Therefore, your\noperating procedures must ensure that these requirements are met when the cylinder is offered\nfor transportation.\nI hope this satisfies your request.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\ndekman\n$173.304\nCylinders\nDodd, Alice (PHMSA)\n15-0102\nFrom:\nGeller, Shelby CTR (PHMSA).\nSent:\nFriday, May 22, 2015 11:52 AM\nTo:\nHazmat Interps\nSubject:\nFW: Interpretation Solicitation - Gas Transfill Process of DOT 3AL 3000 cylinder\nDear Shante and Alice,\nAttached is a request for a formal letter of interpretation. I spoke with Mr. Miro about his request.\nThanks,\nShelby\nFrom: Juan Miro [mailto:Juan.Miro@ikaria.com]\nTo: PHMSA HM InfoCenter\nSent: Friday, May 22, 2015 11:47 AM\nSubject: RE: Interpretation Solicitation - Gas Transfill Process of DOT 3AL 3000 cylinder\nGreetings,\nTo clarify my questions:\n1. Does the DOT regulation allows overfilling of a cylinder @ 70F during the filling process to compensate for\npressure loss during detachment of the cylinder from the filling manifold?\na. Filling Setpoint 3350 psia @ 70F.\nb. Final Pressure of the cylinder after detachment from the filling manifold - 3000 psia @ 70F or below.\nc. Cylinder type DOT 3AL 3000.\nHope this clarifies my request.\nThanks\nRegards,\nJuan Miró | Project Manager | Engineering Department\nMallinckrodt Pharmaceuticals, formerly Ikaria, Inc.\n1060 Allendale Dr Port Allen, LA 70767\nT 225-376-4373 | M 225-335-0817 | F 225-376-4493\nhttp://www2.mallinckrodt.com/ikaria/\nFrom: Juan Miro\nSent: Thursday, May 21, 2015 6:32 PM\nTo: 'phmsa.hm-infocenter@dot.gov'\nSubject: RE: Interpretation Solicitation - Gas Transfill Process of DOT 3AL 3000 cylinder\nGreetings,\n1\n\n<<<PAGE 3>>>\n\nFollowing up on the request below. Can you please inform what are the next steps discuss and obtain the\ninterpretation?\nThank You\nRegards,\nJuan Miró | Project Manager | Engineering Department\nMallinckrodt Pharmaceuticals, formerly Ikaria, Inc.\n1060 Allendale Dr Port Allen, LA 70767\nT 225-376-4373 | M 225-335-0817 | F 225-376-4493\nhttp://www2.mallinckrodt.com/ikaria/\nFrom: Juan Miro\nSent: Wednesday, May 06, 2015 2:48 PM\nTo: 'phmsa.hm-infocenter@dot.gov'\nSubject: Interpretation Solicitation - Gas Transfill Process of DOT 3AL 3000 cylinder\nGreetings,\nMy name is Juan Miró and I am the lead engineer of a medical gas manufacturing facility. I am soliciting an\ninterpretation of DOT regulation regarding the process I am about to describe:\n1. Container Closure:\na. DOT 3AL 3000 cylinder with water volume of 0.074L\nb. Aluminum Schrader type spring loaded valve.\n2. Gas\na.\n1.14% (11400 ppm) Nitric Oxide balance Nitrogen\n3. Process Steps:\na. Attach the container to gas transfer system\nb.\nEvacuate the container to 30mTorr\nc. Pressurize the container to 3350 psia @ 70F (cylinder spends less than 1 minute pressurized to this\nsetpoint before losing pressure during the detachment process).\nd. Detach the container from gas transfer system (pressure loss of 350 psia)\ne. Final container pressure before 3000 psia @ 70F\nThe process described pressurizes the cylinder to 3350 psia @ 70F (3750 psia @ 70F is 5/4 of service pressure). Upon\nreaching 3350 psia the cylinder is ejected from the filling nozzle losing 350 psia in the ejection process. The final\npressure of the cylinder is at 3000 psia or below. After these cylinder are filled the contents are analyzed providing a\nfinal pressure before transport of 2750 psia.\nDoes the process as described complies with DOT regulation? I have assessed the regulation and there is mention of\nheated compression but nothing is mentioned about compensating for sudden pressure loss at the end of the filling\nprocess.\nRegards,\nJuan Miró | Project Manager | Engineering Department\nMallinckrodt Pharmaceuticals, formerly Ikaria, Inc.\n1060 Allendale Dr Port Allen, LA 70767\n2\n\n<<<PAGE 4>>>\n\nT 225-376-4373 | M 225-335-0817 | F 225-376-4493\nhttp://www2.mallinckrodt.com/ikaria/\nplease inform the sender and remove any racord of this message.\nThis information may be confidential and/or privileged. Use of this information by anyone other than the intended recipient is prohibited. if you receive this in emer,","truncated":false,"body_characters":5685}