Atropine_MPID 2_2025-05-13_FINAL.pdf

MPID NO. 2 (6505-31-017-0350)

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PGC 42850

NUMBER DATE

MEDICAL PROCUREMENT ITEM DESCRIPTION 2 13 May 2025

NATIONAL STOCK NO. ITEM IDENTIFICATION

6505-31-017-0350 ATROPINE INJECTION, Automatic, 2 mg Atropine Sulfate per 0.7 mL

1. SCOPE. This Medical Procurement Item Description covers Rafa’s Atropine Injection,2mg (NDA No. 212319), in a pressure-activated automatic injector (auto- injector) suitable for rapid intramuscular administration.

2. SALIENT CHARACTERISTICS

The product will be provided in accordance with the current specifications as included in NDA No. 212319 at time of delivery.

2.1 Medication. Atropine Injection, 2 mg, shall meet the individual NDA requirements. Each individual ingredient in the formula shall be adjusted depending on the total volume to be delivered. The volume range shall be

0.66 mL to 0.8 mL. The volume shall be the total amount delivered during the injection process and shall be measured by gravimetric means

2.1.1 Assay. The amount of Atropine in Rafa’s 2mg autoinjector shall be 95.0-105.0% at release and 93.0-107.0% during shelf life in accordance with approved NDA No. 212319. The amount of phenol which is a preservative in the formulation shall be 90.0-105.0 at release and 70.0-105.0% during shelf life.

All ingredients used in the formulation shall comply with compendial standards (USP/NF) in accordance with the approved NDA no. 212319.

2.1.2 pH. The pH of the injection (solution) shall be from 4.1 to 4.5 when tested at 25o C, in accordance with the approved NDA No. 212319.

2.1.3 Clarity and color. At time of release, the solution color should not be darker than a color standard at 420 nm. Upon release, the product should be clear. The solution shall meet the current USP particulate matter limits for injectables and shall be virtually free from undissolved or visible particulate matter when examined.

2.2 Auto-injector.

2.2.1 Shall be a pressure-activated auto-injector suitable for use in rapid intramuscular administration of the contained medication. Shall be designed to operate in an ambient temperature range of 39.2oF (4oC) to 104oF (40oC), when tested as specified in the approved NDA No. 212319.

2.2.2 Shall be a cylindrically shaped, smoothly formed, spring operated, automatic injection device, weighing a maximum of 20 grams, with an overall length not exceeding 100 mm and a maximum diameter of the unit itself of 14 mm, with the maximum diameter of the finger grip on the yellow safety of 13.0 mm and a minimum of 12.0 mm.

2.2.3 Shall be suitable for use in rapid intramuscular self-

administration of the contained medication by untrained personnel. The

Page 2 of 7 Pages dispensing time shall not be more than average half a (0.5).seconds. The device shall have the needle end permanently identified by a green-colored, smoothly-finished cap having a centered "DARK GREY EYE". The arming end shall have a safety pin protected by a yellow-colored covering cap having the following nominal dimensions:

Length 18.1 ± 0.3 mm Diameter of closed end 12 mm.

2.2.4 The covering cap shall form a tight fit with the head of the safety pin in such a manner that it shall not revolve and cannot be removed without removing the safety pin. Each end of the device shall be so formed as to be ascertained visually or by tactility under all combat conditions.

2.2.5 Shall contain a safety mechanism, which shall prevent accidental arming or discharging of the device through dropping, snagging, bumping, buffeting or the unintentional actions by the potential user. The device shall be activated easily and readily by manual operations.

2.3 Needle. The effective length (point to front of stopper) of the needle shall be not less than 19.1 mm nor more than 22.2 mm when tested as specified in 4.3.3. The needle length shall be measured from the tip of the exposed needle to the tip of the auto-injector. The gauge of the needle shall be 22 gauge AISI 304 stainless steel.

2.4 Sterility. The injection (solution) and all components and surfaces in contact with the injection (solution) shall be sterile. When the injector is activated and the solution is ejected, the liquid shall be sterile when tested in accordance with the current edition of the USP.

2.4.1 Certification of sterility. A certificate of sterility, listing all lot (control) numbers, shall state that samples from each sterility lot have been tested in accordance with the USP method and found to be sterile.

2.5 Bacterial endotoxin. The solution shall meet the requirements when tested in accordance with the current specifications as included in NDA No. 212319.

2.6 Chemical/physical interactions. The drug container with the solution shall be compatible such that the auto-injector shall meet functional, chemical, microbiological specifications throughout the shelf life as detailed in the approved NDA.

2.7 Activation force. Shall be of sufficient dimensional stability that the item shall fire in a range of 0.90 — 3.60kg (2.0 to 8.0 pounds) of directly applied triggering force. The firing forces shall be determined by removing the safety cap and placing the auto-injector on a stand. A spring scale shall be used to apply a force to the injector at the safe end. The magnitude of this force shall be observed at the instant of firing of the injector. The activation action shall consist of rapidly extending the needle from the end of the device and simultaneously ejecting 0.70 mL (+0.10 mL / -0.04 mL) of the contained solution through the needle. The device shall deliver 1.67 mg atropine base (equivalent to 2 mg atropine sulfate). The activation action shall consist of rapidly extending the needle from the end of the device and simultaneously ejecting a sufficient amount of solution (in a range of 0.66 mL to 0.80 mL) to deliver 1.67 mg atropine base (equivalent to 2 mg atropine

Page 3 of 7 Pages sulfate), through the needle. The front end of the auto-injector shall not become dislodged during activation.

2.8 Volume of medication and dispensing time. The auto-injector shall dispense 0.66 to 0.80 mL to deliver 1.67 mg atropine base (equivalent to 2 mg atropine sulfate), through the needle during a test period of not more than 0.5 seconds from the time of activation, when tested as detailed in the approved NDA.

2.9 Accelerated aging. The auto-injector shall meet the requirements on activation force, ejected volume, ejection time, and exposed needle length, as detailed in the approved NDA (see 4.3.1 and 4.3.2).

2.10 Rough handling. The auto-injector shall meet the requirements on activation force, ejected volume, ejection time and exposed needle length, as detailed in the approved NDA and in accordance with ASTM D4169-16 (see 4.3.3).

2.11 Safety mechanism. The auto-injector shall not activate with the safety mechanism in place when a force of 9 kg (20 pounds) is axially applied after shaking and dropping as detailed in the approved NDA (see 4.3.7).

2.12 Reliability. The auto-injector shall be 99.5% reliable as demonstrated by performance qualification testing by the manufacturer.

2.13 Ability to withstand high altitude (low pressure). The auto-injector shall retain the contained solution when subjected to a simulated altitude of 33,000 feet, as demonstrated by performance qualification testing by the manufacturer (see 4.3.3).

2.14 Retain samples for stability testing. Retain samples as per current CGMP requirements.

2.15 Expiration dating period. Rafa’s current NDA includes a shelf life of 36 months.

2.15.1 Delivery. Not less than 24 months of the expiration dating period shall remain at time of delivery to the Government.

2.17 Permanency of marking. Each auto-injector shall be permanently and legibly marked or labeled, as specified herein. Labels shall be durable and waterproof. Marking shall remain entirely legible; labels shall be unaffected and shall remain firmly affixed to the auto-injector, as demonstrated by tests detailed in the approved NDA.

2.17.1 Label information. The label on each auto-injector shall be FDA approved (NDA No. 212319). See below a picture of the approved label which may be updated from time to time as per discussions with the FDA.

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2.18 Individual atropine auto-injector package. Each atropine auto-injector shall be packaged in a sealed bag fabricated from polyethylene, having a thickness of 0.08mm ± 0.01 mm (0.003 inch + 12% is acceptable).

The bag may be either transparent or subdued olive drab, or a combination of both, minimally reflective or non-reflective. The auto-injector shall not be so loose fitting in the packaging as to allow the safety cap of the auto-injector to come off the device while in the packaging. The bag shall have either a snap-apart (scored) feature (without any perforations) close to one end of the bag for quick snap-apart opening, or shall have notches in the side seams to allow easy tear-opening of the bag. The auto-injector shall be packaged with the yellow safety pin cap at the scored (snap apart) or notched end of the package.

2.19 Workmanship. Product will be manufactured in Rafa’s certified facility and in accordance with the approved NDA.

3. REGULATORY REQUIREMENTS

3.1 Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulation’s promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/ suppliers, with the requirements of all other applicable Federal, State and local statutes, ordinances, and regulations.

3.2 Recovered materials

The offeror/contractor is encouraged to use recovered material in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical.

4. QUALITY ASSURANCE PROVISIONS

4.1 Responsibility for inspection. Unless otherwise specified in the contract, the contractor is responsible for the performance of all inspection requirements, as specified herein. Except as otherwise

Page 5 of 7 Pages specified in the contract, the contractor may use his own or any other facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specifications, where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.

4.1.1 Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government, upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.

4.1.2 All sites involved in production and testing of Rafa’s product are listed in Rafa’s approved NDA No. 212319.

4.1.3

4.2 Quality conformance inspection.

4.2.1 Lot.

4.2.1.1. Lot for inspection. For purposes of this specification, a lot, batch or control is that single, uniform, and homogenous quantity of the medication produced from one formulation, subjected to the same compounding and manufacturing operation, and filled into final containers.

4.2.1.2. Pharmaceutical lot for finished auto-injectors. A lot shall consist of the auto-injectors produced from one lot of the medication at the sites approved under NDA No. 212319, under essentially the same manufacturing conditions. Sterility sub lots may be defined, sampled, and tested in accordance with USP definitions.

4.2.1.3. Lot for Water for Injection, USP. Water for Injection shall meet the requirements of the USP.

4.2.2 Sampling. Where possible, the sample shall be used for 2 or more tests. All samplings are performed according to relevant ISO/GMP guidelines.

4.3 Tests.

All tests listed in the approved NDA shall be performed in accordance with the approved NDA No. 212319.

4.3.1 Accelerated Aging Test 1. The individually packaged auto-injectors shall be subjected to a high temperature of 65oC (149oF) +/- 2o for 14 days.

4.3.2 Accelerated Aging Test 2. The individually packaged auto-injectors shall be subjected to alternating temperatures of 55oC (131oF) +/- 2o for

72 hours then shall be subjected to a low temperature of 0oC (32oF) +/- 2o for 72 hours and then be subjected to high temperature of 55oC (131oF) +/- 2o for 72 hours.

4.3.3 Additional tests (initial qualification). Rough handling tests, Handling, Stacked vibration (Truck profile) test, Stacked vibration (Air profile) test, Low pressure test, Vehicle vibration (Truck profile) test, Vehicle vibration (Air profile) test, Concentrated Impact test, Handling (Second sequence) tests were performed as part of initial qualification and are detailed in the approved NDA.

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5 PACKAGING.

5.1 Preservation. Preservation shall be military, as specified. More information can be located from the preservation methods of MIL–STD–2073–1, Standard Practice for Military Packaging.

5.2 Unit. Each (EA). One Atropine auto-injector, as specified, constitutes one unit. Each auto-injector shall be packaged as specified in 2.18.

5.2.1. Intermediate package. Forty individually packaged Atropine auto-injectors shall be packaged in a box of appropriate size. Packing.

Packing shall be level A, as specified.

5.2.2. Exterior (shipping) container. Twelve intermediate packages (480 units) shall be packed in an exterior container.

5.2.3. Packing variation permitted. If the required number of units to be shipped is less than the number of units specified to be overpacked in an exterior (shipping) container, such units shall be packed in an exterior (shipping) container of suitable size and design, conforming to requirements specified in 5.2.1.

5.3. Marking.

5.3.1. Unit. Each Atropine auto-injector shall be marked as specified in 2.17.1.

5.3.2. Unit container (tamper-evident bag). Markings identifying the contents on each auto-injector shall be FDA approved (NDA No.

212319). A picture of the approved label which may be updated from time to time as per discussions with the FDA is presented in section 2.17.1.

5.3.3. Intermediate package. Each intermediate package shall be The label on each auto-injector shall be FDA approved (NDA No. 212319). See below a picture of the approved label which may be updated from time to time as per discussions with the FDA.

5.3.4. Exterior (shipping) container and unitized load. Each exterior (shipping) container and unitized load shall be FDA approved (NDA No.

212319). See below a picture of the approved label which may be updated

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6 NOTES.

Source of documents.

Approved NDA No. 212319