JP2000015661A - Manufacture of molding for plastic pharmaceutical or medical appliance - Google Patents

Abstract

PROBLEM TO BE SOLVED: To eliminate necessity of a removing step of an infinitesimal solid-like deposit by automating the steps from molding to packaging of the molding. SOLUTION: All the steps of molding the molding for a plastic pharmaceutical or a medical appliance to packaging the molding via the inspecting step at least to the inspecting step in a clean room are automatically conducted. Thus, the molding can be shipped without removing an infinitesimal solid-like deposit of the molding fed via the molding to the inspecting steps. The molding for the plastic pharmaceutical or the medical appliance such as a syringe, vial or the like for omitting a removing treatment by cleaning or the like of particle- like or the like solid-like deposit is obtained.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for producing a plastic molded article for pharmaceuticals and medical devices which does not require removal treatment such as washing and removing of fine solid deposits after molding.

[0002]

2. Description of the Related Art Conventionally, molded articles for pharmaceuticals and medical devices, such as vials and syringes (which mean a syringe barrel in the present invention, but are described below as syringes), have been manufactured from various plastics. ing. As in the case of other general molded bodies, these molded bodies are molded at a temperature of 100 ° C. or higher using a molding machine such as an injection molding machine in a normal air atmosphere. During the packaging process, the compact is exposed to human hands during and during the packaging process, and is exposed to the atmosphere of each process in which various suspended matters are present. Adherence is inevitable, and it is necessary to remove the adhered matter before shipping.

[0003]

The removal of fine solid deposits on plastic molded articles for pharmaceuticals and medical devices is usually carried out by
It is performed after the molding quality inspection of the molded body, and as a method of removing the attached matter, cleaning with dust-free cleaning water containing no fine solid substance is generally used. After washing, it is subjected to a disinfecting / sterilizing treatment as required, and after drying, it is packed and shipped. For pharmaceuticals
Fine solid substances adhered to vials and syringes, which are plastic molded products for medical devices, are administered to the human body together with medicines by syringes depending on the size, but when administration is performed via blood vessels, thrombus formation, etc. The number of particulate matter in an injection is strictly regulated by various official standards such as the thirteenth revised Japanese Pharmacopoeia General Rules.

[0004] However, it is not easy to remove the fine solid matter adhering to the above-mentioned molded product, and various removal methods have been studied, but a satisfactory method has not been found yet. There is also an attempt to automate the process from molding to packaging process of a plastic molded article for pharmaceuticals and medical devices to avoid human contact with the molded article. However, it is difficult to automate the process from the viewpoint of the properties of the molded product, and the process from the molding of the molded product to the packaging process has not yet been automated.

The present invention has been made in view of the above background, and an object of the present invention is to provide a method of manufacturing a molded article for a plastic drug or medical device which does not require a step of removing fine solid deposits. To provide. The present inventor is common in the manufacture of semiconductors, optical equipment, electronic precision equipment, bioproducts, pharmaceuticals, etc., but has never been implemented in the manufacture of plastic molded articles, and nobody has come to mind. The idea is that all processes from molding to packaging that were not obtained are automatically performed in a clean room with a specific air cleanliness. The present inventors have found that the removal process of elimination is unnecessary, and completed the present invention.

[0006]

According to the present invention,
In the method for producing a plastic molded article by the following steps, (1) a step of molding a molded article, (2) a step of removing a molded article from a molding machine, (3) a step of transporting the molded article, and (4) a molded article And (5) the step of packaging the molded body, wherein at least the steps (1) to (4) are automatically performed in a clean room, and the removal processing of fine solid deposits is performed. The present invention provides a method for producing a molded article for a plastic drug or medical device which can be omitted.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION Next, the present invention will be described in detail with reference to preferred embodiments of the present invention. The feature of the present invention is that all processes from the step of molding a plastic for a raw material and a medical device using an injection molding machine to the step of packaging the molded article through an inspection step are performed in a clean room. That is, at least the steps up to the inspection step are performed automatically. By doing so, it is possible to ship the molded product that has undergone the inspection process from the molding without removing the fine solid deposits on the molded product. When any of the steps described below is performed in a normal air atmosphere, it is necessary to remove fine solid deposits attached to the molded body after inspection,
It is necessary to perform all processes from molding to packaging in a clean room.

[0008] The plastic molded articles for pharmaceuticals and medical devices to which the present invention is applied are made of plastics, for example, syringes of various capacities (both with and without a luer lock). Conventionally known ones such as vials (preparation containers) and ampoules of various capacities are included, and are not limited to these examples. Further, fine solid deposits that adhere to the above-mentioned molded product during the molding process and the like include various shapes such as particles, fibers, and rods, but the shape is not particularly limited.

In the present invention, as a raw material plastic used for forming a plastic molded product for a pharmaceutical or medical device, any plastic conventionally used for producing these plastic molded products can be used. Is not particularly limited. Among them, preferred is a polymer of a cyclic olefin compound. Examples of the polymer of a cyclic olefin-based compound include a ring-opened (co) polymer and an addition (co) polymer of a cyclic olefin-based compound, and hydrogenated products thereof. The cyclic olefin-based compound includes a monocyclic olefin-based monomer and a bicyclic or higher polycyclic olefin-based monomer as exemplified below.

The monocyclic monomers used for producing the cyclic olefin (co) polymer include, for example, monocyclic olefin monomers such as cyclopentene, cyclopentadiene, cyclohexene, methylcyclohexene, cyclooctene and the like. Examples of the substituent include a lower alkyl derivative having 1 to 3 lower alkyl groups such as a methyl group and an ethyl group, and an acrylate derivative.

Examples of the polycyclic olefin monomer include dicyclopentadiene, 2,3-dihydrocyclopentadiene, bicyclo [2,2,1] -hept-2-ene and derivatives thereof, and tricyclo [4, 3,0,1 ^2,5 ]
-3-decene and its derivatives, tetracyclo [4,4,
0,1 ^2,5] -3-undecene and derivatives thereof, tetracyclo [4,4,0,1 ^2,5, 1 ^7,10] -3-dodecene and derivatives thereof, pentacyclo [6,5,1,1 ^3,6 ,
0 ^2,7, 0 ^9,13] -4-pentadecene and derivatives thereof,
Pentacyclo [7,4,0,1 ^2,5, 0,0 ^{8 and 13,} 1
^9,12] -3-pentadecene and its derivatives, hexacyclo [6,6,1,1 ^3,6, 1 ^10,13, 0 ^2,7, 0 ^9,14]
-4-heptadecene and its derivatives.

Examples of the derivatives of bicyclo [2,2,1] -hept-2-ene include, for example, 5-methyl-bicyclo [2,2,1] -hept-2-ene and 5-methoxy-bicyclo [2 , 2,1] -Hept-2-ene, 5-ethylidene-bicyclo [2,2,1] -hept-2-ene, 5
-Phenyl-bicyclo [2,2,1] -hept-2-ene, 6-methoxycarbonyl-bicyclo [2,2,1]
-Hept-2-ene and the like.

Tricyclo [4,3,0,1 ^2,5 ] -3-
Derivatives of decene, 2-methyl - tricyclo [4,3,0,1 ^2,5] -3-decene, 5-methyl - tricyclo [4,3,0,1 ^2,5] -3-decene Is mentioned.

Tetracyclo [4,4,0,1 ^2,5 ] -3
- Derivatives of undecene, 10-methyl - tetracyclo [4,4,0,1 ^2,5] -3-undecene and the like,
Derivatives of tricyclo [4,3,0,1 ^2,5 ] -3-decene include 5-methyl-tricyclo [4,3,0,1
^2,5 ] -3-decene and the like.

[0015] tetracyclo [4,4,0,1 ^2,5, 1
^7,10] -3 Derivatives of dodecene, 8-ethylidene - tetracyclo [4,4,0,1 ^2,5, 1 ^7,10] -3
-Dodecene, 8-methyl-tetracyclo [4,4,0,
1 ^2,5, 1 ^7,10] -3-dodecene, 9-methyl-8-methoxycarbonyl - tetracyclo [4,4,0,
1 ^2,5, 1 ^7,10] -3-dodecene, 5,10-dimethyl - tetracyclo [4,4,0,1 ^2,5, 1 ^7,10] -3-
Dodecene and the like.

[0016] hexacyclo [6,6,1,1 ^3,6, 1
^{10 and 13,} 0 ^2,7, Derivatives of 0 ^9,14] -4-heptadecene, 12-methyl - hexacyclo [6,6,1,
1 ^3,6, 1 ^10,13, 0 ^2,7, 0 ^9,14] -4-heptadecene, 1,6-dimethyl - hexacyclo [6,6,1,1
^3,6, 1 ^10,13, 0 ^2,7, and 0 ^9,14] -4-heptadecene, and the like.

At least one of cyclic olefinic compounds or at least one of cyclic olefinic compounds and at least one of olefinic monomers (for example, ethylene, propylene, 4-methylpentene-1, cyclopentene,
Addition (co) polymers of cyclooctene, butadiene, isoprene, styrene, etc.) can be used to convert these monomers into, for example, a known catalyst comprising a vanadium compound or the like and an organic aluminum compound or the like soluble in a hydrocarbon solvent as a catalyst. It can be obtained by polymerization using a catalyst (see JP-A-6-157672 and JP-A-5-43663).

The ring-opening (co) polymer of the above monomers may be used as a catalyst, for example, (1) halides of platinum group metals such as ruthenium, rhodium, palladium, osmium and platinum;
A catalyst comprising a nitrate or the like and a reducing agent; (2) a periodic table I to IV of a transition metal compound such as titanium, molybdenum or tungsten and an organoaluminum compound or an organotin compound;
Catalysts comprising organometallic compounds of group metals (JP-A-6-15
No. 7672, JP-A-5-43663, etc.) and (co) polymerization of the monomer using a known catalyst.

When the (co) polymer obtained above has an unsaturated bond, it is hydrogenated using a known hydrogenation catalyst. Examples of the hydrogenation catalyst include (1) a Ziegler-type homogeneous catalyst comprising an organic acid salt such as titanium, cobalt, and nickel and an organic metal such as lithium and aluminum; and (2) a platinum group metal such as palladium and ruthenium. , A supported catalyst supported on a carrier such as alumina,
(3) Complex catalysts of the above platinum group metals (JP-A-6-157)
672 and the like).

In the present invention, the above hydrogenated (co) polymer is a ring-opened polycyclic saturated hydrocarbon compound having two or more rings or a compound having a substituent having a polymerizable double bond. Also included are (co) polymers and addition (co) polymers. Examples of commercially available polymers of cyclic olefinic compounds include ZEONEX manufactured by Zeon Corporation and Apel COC manufactured by Mitsui Petrochemical Company.

The steps for producing a molded article for a plastic drug or medical device will be described below. Each process is linked and managed online. The following description shows an example of each step, and each step is not limited to these examples. In the present invention, the type of a molding machine used for producing a molded product for a plastic drug or medical device is not particularly limited, but the production of the molded product is performed by an injection molding machine or an injection stretch blow molding machine. In general, molding by an injection molding machine will be described below.

(1) Molding process by injection molding machine In accordance with the type of the molded article to be produced based on the production plan, only the mounting of the mold on the injection molding machine is performed manually.
Operating conditions of the injection molding machine, such as mold closing pressure, mold temperature,
Operating conditions such as melting temperature, nozzle temperature, injection pressure, and cycle time are input from an online terminal to a computer that controls automatic operation of the injection molding machine. When the preparation for the operation of the injection molding machine is completed, a predetermined amount of plastic as a raw material is automatically supplied to the injection molding machine from the raw material tank, and the production of a molded body is started. A container for storing the manufactured molded body is automatically supplied to the injection molding machine by an automatic guided vehicle or the like.

(2) Step of taking out a molded article (product) An injection molding machine is operated in accordance with operating conditions input to a computer to mold a target molded article (a syringe, a vial, etc.) and provided in the injection molding machine. The runner portion is discharged from the mold to the runner discharge conveyor by the runner take-out mechanism, and the molded product is stored in a container by the robot.

(3) Conveying step of the molded article When a predetermined number of molded articles are stored in the container, the empty container is automatically sent to the injection molding machine in accordance with the container recovery request from the injection molding machine and the supply request of the empty container. And the container containing the compact is automatically conveyed to the product inspection process. As a means for transporting the container to the injection molding machine and the inspection process, it is preferable to use a transporting means which does not generate fine particles such as frictional metal scraps due to rotation. For example, a non-contact power feeding transporting system utilizing magnetic force is preferred. As means.

(4) Inspection Step of Molded Body The container storing the molded body transported to the inspection step by an unmanned transport vehicle or the like is temporarily stored in an automatic rack in an inspection room as occasion demands, and based on the inspection schedule, The moldings are automatically supplied one by one from the container to the inspection machine by the robot and are automatically inspected. The shape of a molded product for pharmaceuticals and medical devices is usually cylindrical, and the molded product is generally scratched, stained, and contaminated with foreign matter. Silver (silver generated by air or moisture along the flow direction of the resin on the molded product surface) Streak), chipping,
The presence or absence of cracks is examined, and if any of these is confirmed, the molded body is removed as a defective product.

A preferred inspection method in the present invention is, for example, an inspection for contamination of the molded body, contamination, chipping, and cracking of the molded body, for example, by light transmitted by light emitting diode (LED) illumination, and for inspection of silver and flaws. In the inspection, the quality of the molded body is automatically determined based on the captured images, for example, by reflected light of halogen light irradiation, in accordance with a criterion programmed in a computer.
The present invention is also characterized in that the inspection of the molded body is performed using an image based on the transmitted light of the molded body and an image based on the reflected light on the surface, and the inspection is performed by such a method to automate the inspection process without human intervention. It became possible.

An inspection method will be specifically described by taking a syringe (syringe) as an example of a molded body. The compacts are taken out of the container one by one by a robot and supplied to an inspection device. First, the cylindrical portion excluding the flange portion at the rear end of the syringe barrel and the top surface at the tip (the surface having the syringe needle mounting portion at the tip of the syringe barrel) is inspected. The cylindrical part inspection device is disposed in close proximity to a light emitting diode (LED) illuminating device and a halogen lamp illuminating device for irradiating light to the entire syringe barrel, and a syringe barrel for photographing transmitted light and reflected light of the syringe barrel. And a camera. At the time of photographing, the transmitted light from the entire length of the syringe barrel cannot be photographed by one camera due to the restriction of the wide angle of the lens, so the entire length of the syringe barrel is divided into a plurality of parts, and each divided part is divided. A plurality of cameras corresponding to the number of divisions are used so that a photograph can be taken by duplicating a boundary portion between each other.

When photographing the transmitted light from the light source through the syringe barrel, the LED illuminator is used as the light source, and the light from the light source is divided into approximately half the width in the length direction of each divided part of the syringe barrel. At an equivalent width, approximately 1/3 to 1/2 of the outer diameter of the cylinder in the circumferential direction
Irradiate through a slit so as to have a width of that time,
First, the transmitted light from the part including the part of the boundary between the right (or left) half and the left (or right) half of each divided part is photographed (first inspection). Next, the injection cylinder is moved and the left (or right) half of each divided part is photographed in the same manner as described above (second inspection). The above photographing is performed while the cylinder is rotated once to cover the entire circumference of the cylinder. The rotation is performed at a speed not exceeding the photographing speed of each time. For each inspection, the captured video over the entire circumference of each division is displayed on the monitor,
If there is a foreign substance in the cylinder, the surface is dirty, or there are chips, cracks, etc., these appear as black parts in the image on the monitor, and the computer judges the quality according to the programmed criteria. Is performed, and the injection cylinder determined to be defective is removed by the robot. still,
The rotation of the syringe barrel is performed by rotating the arm of the robot holding the flange, and the inspection is completed with one rotation. The positional relationship between the syringe, the light source and the camera in the above inspection may be such that the light transmitted through the syringe directly enters the camera.For example, the light source is arranged below the syringe and the camera is arranged above. An example of the arrangement is given.

When the inspection using the transmitted light is completed, the light source is changed to a halogen lamp illuminating device, and the presence or absence of silver streaks or scratches on the surface of the injection cylinder is inspected based on an image obtained by photographing the reflected light. The arrangement of the illuminating device is changed so that an image can be taken by reflected light, and the irradiation range of each divided portion is set to be approximately one third or less of the circumferential width of transmitted light.
The operation is the same as that of the above-mentioned transmitted light except that it is reduced to 1/2. If there is a silver streak or scratch on the syringe barrel surface, the irradiated light is scattered at that part, the reflected light is weaker than the reflected light at other parts, it appears as a black part on the image on the monitor, and as above The computer determines pass / fail, and the syringe that is determined to be defective is removed by the robot.

The syringes determined to be non-defective in the above inspection are:
In order to inspect the top surface and the flange portion of the syringe, it is supplied to the next inspection device by a robot. The inspection of the top surface portion and the flange portion is determined based on an image obtained by photographing the reflected light of the surface. A halogen lamp illuminating device is used as a light source to inspect for scratches, inclusion of foreign matter, and the like. The specific inspection method is as follows. Two cameras are used to respectively capture the reflected light from the predetermined irradiation range on the top surface and the flange of the syringe barrel. By alternately photographing the reflected light from the top surface and the flange, inspection of both portions is performed simultaneously. In this case as well, the syringe is rotated once at a speed corresponding to the imaging speed in the same manner as the above-described inspection,
The inspection is completed in one rotation.

(5) Forming Process of Molded Product As a result of the above inspection, the molded product determined to be non-defective (passed product) is stored in a packaging container by a robot, and when a predetermined number is reached, a conveyor or the like is performed in the packaging process. Sent and packaged. A predetermined number of compacts are packed in a dust-free packaging bag by a robot and sealed. The sealed bags are manually stored in the required number of cardboard boxes, sealed and shipped.

The above is a description of each example of the steps, but each of these steps must be performed in a clean room. Usually, the steps from the molding step to the start of the transfer of the molded body are performed in the same clean room, and the inspection step and the packaging step are performed in another clean room. In addition, even during the transfer of the molded body, the path is maintained at the same cleanliness as the clean room. The cleanliness of the room where each process is performed depends on the capacity of the room,
Although there is a difference depending on the number of installed devices and the like, a class of 10,000 is required to omit the step of removing particles attached to the molded body.
0 (the number of particles having a diameter of 0.5 μm or less in 1 m ^{3 of} air is 1
A cleanliness of no more than 000) is preferred.

The Japanese Pharmacopoeia of the thirteenth revision states that the number of insoluble fine particles in an injection conforming to the insoluble particle test method for an injection prescribed by the Pharmacopeia (using an automatic light-shielding type fine particle measuring device). The maximum number of large-volume injections of 100 milliliters (ml) or more is 25 or less for 10 μm or more, 3 or less for 25 μm or more, and small for less than 100 ml, in terms of the number in 1 ml of injection. The volume of injection is 1
6000 or less, 10 μm or more per container, 25
The number of those having a size of μm or more is 600 or less.

The plastic molded article for pharmaceuticals and medical devices manufactured by the above method conforms to the above-mentioned limit of the number of insoluble fine particles of the Japanese Pharmacopoeia. -The process of removing the attached fine particles after the sterilization process can be omitted. In the case of pharmaceutical containers such as vials, it is possible to omit the treatment for removing fine solid deposits at the delivery destination and fill the medicine only with the destruction / sterilization treatment.

[0035]

Next, the present invention will be described specifically with reference to examples and comparative examples.

Example 1 and Comparative Example 1 All the steps were carried out in a clean room of class 10,000 cleanliness. A predetermined amount of a polymer of a cyclic olefin compound (ZEONEX manufactured by Zeon Corporation) is automatically supplied to an injection molding machine in which operation conditions are input, and the outer diameter is 35.0 to 35.0 at a set mold temperature and injection nozzle temperature. 50 ml of 35.5 mm, 150 mm long, 100 ml syringes
0 were produced. The molded products taken out on the conveyor are packed by robots into five containers of 100 each in the order of molding, and one of the containers is moved on the track to the inspection room on the second floor of the same stand by the non-contact power supply transport system. It was transported by an automated guided vehicle.

In the examination room, first, the syringe is supplied by a robot to an image inspection apparatus for photographing transmitted light and reflected light of the light applied to the syringe to check the quality of the syringe. In the image inspection apparatus, a light source for transmitted light and a camera, a light source (red LED illumination) below the syringe tube with the syringe tube interposed therebetween, and a camera at a position symmetrical to the light source.
The light source for reflected light (halogen lamp illumination) is disposed diagonally above the syringe barrel at a position where the reflected light from the surface of the syringe barrel is incident on the camera at the above-mentioned position. Four cameras are installed so that the total length of the syringe barrel can be divided into four parts for photographing. The entire syringe barrel is irradiated with light from the red LED illuminator, and first, the right half of each divided portion is photographed with transmitted light, and then the syringe barrel is moved to photograph the left half. The case of imaging with reflected light is the same as the case of imaging with transmitted light, except that the light source is replaced with a halogen lamp illumination device. In the case of transmitted light, in the case of transmitted light, the width in the length direction is slightly larger than の of the division width on the horizontal contact surface at the lower part of the syringe barrel, and the portion with the vertical width of 14.5 mm is reflected light. In this case, the width in the longitudinal direction of the upper surface of the injection cylinder is the same as that described above, and the slit is transmitted so that a portion having a vertical width of 6 mm is irradiated.

For inspection, the flange of the syringe is gripped by the arm of the robot, the syringe is inserted horizontally into the above position, and the arm is moved at a shooting speed in order to perform imaging over the entire periphery of the syringe. Shoot while rotating one turn at a speed commensurate with. First, the image obtained by shooting the transmitted light is divided into the right part and the left part of each divided part and displayed on the monitor,
The computer determines pass / fail according to the programmed pass / fail criteria, and the syringe barrel determined to be defective is removed by the robot and transferred to a defective container. Next, similarly, the inspection using reflected light is performed, and the injection cylinder determined to be defective is removed by a robot and transferred to a defective product container. The robot was made to randomly extract 10 injections or the like from the container and inspected with the above-mentioned inspection apparatus, and all were good.

When the inspection of the cylindrical portion is completed, the syringe is supplied to the next inspection device. Here, the top surface and the flange are inspected. The inspection was performed according to the above-mentioned method, and all were good.

Of the remaining four containers not transferred to the inspection room, two were left in the molding room for 3 hours, the other was left for one day, The kimono was transferred to an examination room to measure the number of kimonos, and immediately, 10 syringes were randomly extracted from each container and measured. For comparison, the remaining two containers were transferred to a normal room outside the clean room immediately after molding, one was left for 3 hours, the other was left for one day, and then transferred to the inspection room. Similarly, the number of fine solid deposits was measured. The measurement of the attached matter was performed by the following method.

Test method (1) (for barrel inner surface) The barrel tip was held down with parafilm washed with dust-free water.
After about 100 ml of dust-free water is introduced from the flange, the flange is suppressed with the parafilm. Next, the barrel is turned sideways (horizontally), and is shaken right and left at a speed of reciprocating two times per second over a width of about 10 cm, and reciprocated 20 times. After the shaking, the parafilm at the barrel tip is peeled off, and the content liquid is transferred to a 100 ml beaker washed with dust-free water, and this is used as a test liquid. The above operation was performed on 10 barrels, and an automatic particle counter in liquid (Kion K.R.
L-01), the number of fine particles is measured. Each test solution is measured three times, and the average value is determined.

Test Method (2) (Whole Barrel) Put one barrel in a clean bag (dust-free bag: 300 × 450 mm), add 300 ml of dust-free water, and lightly weigh up and down.
After shaking, the inner solution was linearly cleaned with dust-free water.
Transfer to a vial for l, use this as a test solution, measure each test solution in the same manner as in test method (1), and determine the average value. For clean bags, use 300
of the test solution shaken in the same manner as above. Table 1 shows the above measurement results.

[0043]

[Table 1] (Note) The values in parentheses in the table represent the results for the comparative examples. Immediately after molding, it is about the injection cylinder inspected by the inspection device.

From the results shown in Table 1, it can be seen that by performing the method of the present invention, it is possible to manufacture a syringe which can omit the removal treatment of particulate adhering substances by washing with dust-free water or the like.

[0045]

According to the present invention described above, there are provided plastic molded articles for pharmaceuticals and medical devices such as syringes and vials in which the removal of fine solid deposits such as particulates by washing or the like can be omitted. .

Claims (10)

[Claims] 1. A method for producing a plastic molded article by the following steps: (1) a step of molding a molded article;
(2) a step of taking out the molded body from the molding machine, (3) a step of transporting the molded body, (4) a step of inspecting the molded body, and (5) a step of packaging the molded body, all in a clean room at least. (1) A method for producing a molded article for a plastic drug or medical device, in which the steps of (1) to (4) are automatically carried out, wherein a treatment for removing fine solid deposits can be omitted. 2. The method according to claim 1, wherein the molded body is conveyed by a non-contact power supply conveying means. 3. The step (4), wherein the quality of the molded body is determined based on each image taken by the transmitted light and the reflected light of the surface while rotating the molded body around its central axis. 2. The method for producing a molded article for a plastic drug or medical device according to 1. 4. The molded product is cylindrical, and the quality of the molded product is determined based on an image of each divided portion obtained by photographing the cylinder divided into a plurality of portions in the length direction. The method for producing a molded article for a plastic drug or medical device according to the above. 5. The transmitted light source is an LED lighting device,
4. The light source for reflected light is a halogen lamp lighting device.
Or the method for producing a molded article for a plastic drug or medical device according to 4. 6. The method according to claim 1, wherein the plastic is a polymer of a cyclic olefin compound. 7. The method according to claim 1, wherein the molded body is a syringe barrel (syringe barrel). 8. The method according to claim 1, wherein the molded body is a vial.
7. For a plastic drug according to any one of to
A method for producing a molded article for a medical device. 9. The clean room has a cleanliness of 10,000.
The method for producing a molded article for a plastic drug or medical device according to any one of claims 1 to 8, which is a class or lower. 10. The production of a molded article for a plastic drug or medical device according to any one of claims 1 to 9, wherein the fine solid deposit is in the form of particles, fibers, rods, or a mixture thereof. Method.