DE2032389C3 - Process for the production of absorbable suture material from packs containing polyglycolic acid - Google Patents

Description

40

Virtually all absorbable sutures that are used in animal and human surgery are used nursed from mammalian intestines. These sutures are generally referred to as catgut ·· sutures. Synthetic absorbable sutures have recently become available which, as described in US Pat. No. 3 297 033 is described, can be prepared from polyglycolic acid. These sutures are made of synthetic produced high molecular weight polyglycolic acid. While there is a wide variety of procedures for Making polyglycolic acid is known, but when a high molecular weight polymer is desired the preferred method of making the same is to polymerize practical pure glycolide in the presence of a suitable catalyst such as that in the U.S. patent 2 668 162 is described.

Polyglycolic acid sutures have several advantages towards Catgut. For example, they have a more uniform composition and can be easier to manufacture. You can be charged Märker, d. that is, they have better strength and knot strength and retain their strength longer in vivo. Polyglycolic acid sutures are absorbed in living tissue within W days after implantation.

Despite these advantages of polyglycolic acid as a suture material it was found that ilc desired properties fast with regard to tensile strength and knot resistance as well as the properties in living tissue remove when the middle of the seam! Exposed to moisture. What's even more surprising is that even when dry polyglycolic acid small ones Exposure to amounts of moisture even for a very short time, after long periods of storage, serious Determine impairment of tensile and knot strength as well as the strength of the sutures in vivo as will be discussed in more detail below.

The reason for the aforementioned influence of moisture on the properties of polyglycolic acid sutures While not fully known, several mechanisms are believed to be involved are responsible for this. First, the water can attack the structure of the polymer hydrolytically and thereby degrade and weaken the polymer. It is also possible that the water with the unreacted Glycolide monomers, which may be present in the polymer in an amount up to about 8%, react can and thereby splits the glycolide ring structure into the linear dimer of glycolic acid, which is given by the following formula:

O O

OH - CH ₂ - C - O - CH ₂ - C - Ol 1

The linear dimer in turn can react with the polymer, whereby the polymer with the high molecular weight split into chains with lower molecular weight and thereby the polymer is decomposed to reduce its strength. It is also possible that glycolide or the linear dimers of glycolic acid are formed in the polymer by the thermal decomposition of the same that during processing, e.g. B. during the high temperature extrusion stage, may occur.

In practice, it often happens that a suture takes months and sometimes years after manufacture and packaging is not used. In the meantime, the suture material is under different Environmental conditions stored. Most of these storage conditions include some moisture not from. In view of the aforementioned adverse effect of water on properties Polyglycolic acid sutures must be required to be packaged in one material the ingress of water vapor from the environment surrounding the pack through the packaging through to the suture material contained in the same is prevented. On the other hand prevented a package that practically excludes the entry of water vapor, usually also the exit of water vapor. Therefore, water vapor that is in the package when it is sealed will remain in contact with the seam means. Iis has now been further found that if a dry Sutures themselves only extremely short lines, i. H. 20 minutes less oiler before packing the suture material exposure to moisture has a catastrophic effect on the seam level if this is in a watertight LMi Packaging has been packaged, especially if the pack is then at elevated temperatures is stored.

aims

The invention aims in view of these Difficulties in the stable packaging of polylycolic acid sutures a process for the production of packs for these sutures that ensure that the tensile strength and knot strength as well as the in-vivo strength of the suture itself take longer periods of time under the most adverse temperature and humidity conditions to be kept.

The invention relates to a method of manufacturing of resorbed suture material made from polyglycolic acid-containing packs, characterized in that is that

a) the polyglycolic acid suture is placed in a container made of a material which is practically impermeable to water vapor,

b) the suture and the container are sterilized,

c) practically all of the water is removed from the polyglycolic acid suture material,

d) the suture material dried according to c) before closing the packaging in a practical dry environment is brought and

e) practically the entire gas content of the container is evacuated and the container is then sealed airtight will.

Drying and packaging necessary, the sutures in the meantime in a dry room store where there is no possibility of contact with moisture.

_ In the case of known methods of sterilizing with ethylene oxide, a sterilizing gas is applied to one relatively high pressure (1.76 alü ---- 25 psig) and a relatively high temperature (50 to: 5 C = 120 to 130 F). There is usually a pre-arranged

bene relative humidity (ζ. B. 50 ¹ O) is set. by adding the amount of water necessary to achieve the required relative humidity at the sterilization temperature to the gas. Contact times of 20 hours or more are commonly used. In view of the above-mentioned harmful influence of water and particularly the influence of high temperature water on polyglycolic acid, sterilization of polyglycolic acid sutures is under such extreme conditions

of pressure, temperature and relative humidity. as it has been applied so far over long periods of time were extremely undesirable. Fs is known since. when polyglycolic acid comes into contact with water comes and this takes place in particular at higher temperatures, the decomposition of the polymer very quickly in front of him. The sterilization method of this invention enables the polyglycolic acid sterilized at significantly lower temperatures and pressures in shorter periods of time

In stage c) of the process according to the invention, however, the gas content of the container can also be used after removal be replaced by a gas that

flycolic acid does not react and can become practically moisture-free. Further, no sealed tion gas is added moisture to the Sterilisafrei and thereupon airtight container released and since the _w j _r d, components of the sterilizing gas are anhydrous.

The invention can also expediently be the amount of moisture that is built up in the sterilization its chamber is present by a preferred method, much less than with Anwenzum Sterilizing sutures and containers using known sterilization techniques with ethylene

oxide. It has been found that polyglycolic acid sutures can be sterilized according to the invention. without adverse effects on the train and Knot strength and the in vivo properties of the Adjust suture material.

characterized in that the sterilization by treatment with a gas, the active ingredient thereof Is ethylene oxide and that has the moisture content of the surroundings, for at least 4 hours at one Temperature of about 29 to 32 "C and a pressure of about 0.35 to 1.05 atü is effected.

A particularly suitable container material is aluminum foil. There were different packaging materials with regard to their suitability for storable

Packaging of sutures made from polyglycol 45 sutures; acid test !. For example, when packaging in a vinyl chloride-vinylidene chloride copolymer, the suture material decomposes after storage for only 42 days at 38 C and a relative humidity of 100 ° / ,, completely. A similar 50 Result was obtained with Scotch-Pak film. Scotch-Pak is a laminate made of polyethylene and the polymer Ethylene glycol and terephthalic acid esters.

Before sealing the suture in the container of the invention, it is essential that it be bone dry. It can be made bone dry by heating it long enough to remove water. It is emphasized, however, that once the water has been removed, the suture material must no longer come into contact with a toxic environment, even if this should only be for a very short period of time, since such a brief contact is a serious injury to the node and tensile strength as well as the in vivo lestigkeit after prolonged storage ^r> 5 of the wrapped in a water permeable container Nahtmaterialicn result would have. Fs is therefore hei cinpm temporal Verfahrensabstaiul / wipe with reference to the figures, the invention is explained, for example .

Fig. 1 shows a front view of a preferred embodiment produced according to the invention

F i g. 2 shows a section along the line 2-2 in FIG. waterproof container for the polyglycolic acid suture is shown;

F i g. 3 illustrates, in a flow diagram, a process for making the storable sutures of polyglycolic acid-containing pack according to the invention;

F i g. 4a illustrates the influence of the conditions between the drying of the sutures and packing the same on the tensile and knot strength as a function of storage at 55.5 C ^1;

F i g. 4 shows the influence of the conditions between

: m drying the sutures and packing them on the in-vivo-l estigkeil after 15 lay in Depending on storage at 55.5 C;

F i g. 5a compares the first storage wedge with the urgent one manufactured pack with the one pack with Calgut-Nahlmiitcl under storage conditions of 37.8 ° C and 100% relative humidity;

F i g. 5b compares the durability of the erindui ^ according to manufactured pack with those

Incred packs of Calgut sutures under agitation conditions of 55.5 C and H) ^l 7 “relative humidity.

In the I 'i g. 1 and 2, a preferred embodiment of the packaging used after the establishment is shown. The packaging consists of a tight cover 11 which contains a sterile, braided sewing thread 12 made of polyglycolic acid, connected to a needle, which is wrapped around a paper carrier 13. The packaging is sealed by a leil.Uersiegelung 14 at the edge. The material of the cover 11 is made of a multi-layered, water-impermeable laminate, as best of 1 'i g. 2 can be seen. The laminate has a first layer 15 made of heat-sealable polyethylene, a second layer 16 made of aluminum foil, a third layer 17 made of polyethylene and a fourth layer IH made of printable paper. The casing 11 is produced by placing two pieces of this laminate on top of one another in such a way that the heat-sealable polyethylene layers 15 touch one another. Three of the four edges are then sealed using a heated dye and forming an envelope into which the suture 12 is inserted. After evacuating the contents of the envelope or after replacing this contents with an anhydrous inert gas, the fourth edge of the envelope is sealed and a completely sealed package is produced.

The polyethylene layer 15 preferably consists of a 15 pound low density polyethylene, the one Has a thickness of about 0. U4 mm. The function of this sliding! is. a carrier for the protection of the To provide pack. Of course, another suitable heat-sealable thermoplastic can also be used Plastic can be used. Examples of such substances are vinyl chloride-vinylidene chloride copolymers, Polyolefins with medium and high densities, Tctrafluoräthylcnc and the like.

The aluminum foil 16 should have a thickness of at least about 0.009 mm in order to provide adequate water barrier properties to ensure, whereby thicknesses of about 0.009 to 0.025 mm are expedient and Thicknesses of about 0.013 mm are preferred.

The polyethylene layer 17 is preferably about 0.013 mm thick. It serves as an adhesive carrier for connecting the aluminum layer 16 and the paper layer 18. Of course, another suitable adhesive can also be used for this purpose.

The paper layer 18 preferably consists of “25 lb super-calendered bleached pouch paper” and a thickness of approximately 0.028 mm -b 20%. The function of the paper layer 18 is that it allows direct printing of labels and the like on the outer surface of the package. Therefore any printable paper is suitable.

A method of manufacturing the pack according to the invention is shown schematically in FIG. 3 shown. As In this figure, the needle 19 is firmly connected to the braided strand 20 made of polyglycolic acid, so that a thread 12 provided with a needle is obtained from polyglycolic acid. The thread 12 is then wrapped around the carrier 13. That on the carrier The suture material located is inserted into the sheath 11, which has been produced as described above.

The sheath containing the suture material 12 is inserted into a sealed container which is permeable to the sterilizing gas but not permeable to bacteria. This container is then placed in an ethylene dioxide sterilization oven. The furnace is evacuated, after which a mixture of 12 percent by volume of ethylene oxide and 88 percent by volume of dichlorodiiluormelhan is admitted into the furnace. The furnace pressure is increased to about 0.7 atii, with more of this gas mixture being introduced. The temperature of the gas mixture is kept at 21 to 32 ° C. The mixture of ethylene oxide and dichlorodifluorocylane is non-flammable, non-explosive and safe with regard to all properties that occur when mixed with air. The dichlorodifluoromelhan is practically a diluent, and other suitable diluents, such as carbon dioxide or other dichlorodifluoromelhan gas and mixtures thereof, are also well suited. The most important consideration in sterilization is that the polyglycolic acid suture can surprisingly be sterilized in a relatively dry environment at low temperatures, moderate pressure, and with very short sterilization cycles.

After the suture has been in contact with the Slenlisiergasmisehung for at least 4 hours, preferably 5 hours, the sealed container containing the suture 12 is removed from the ethylene oxide and placed in a drying oven, from then 1 hour under a vacuum of 660 mm to 82 to 87 The sterility of the suture material is maintained during the drying step by preventing the bacteria from entering the container surrounding it. The container is then stored in a dry room 21, ie in an environment that is practically moisture-free until the envelope ti is finally closed, /. For this purpose, the bacteria-proof container containing the envelope 11 and the suture material 12 is removed from the dry room 21 and brought into a sterile room 22, after which the envelope It containing the suture material 12 is removed from the bacteria-proof The gas content of the envelope 11 is removed in the sterile The space 22 is evacuated and the envelope II is sealed, thereby obtaining an airtight vacuum package containing the polyglycolic acid suture.

Alternatively, the gas content of the envelope 11 in the sterile room 22 can be replaced by an anhydrous gas. which is inert to polyglycolic acid, e.g. B. nitrogen, argon, xenon, helium, hydrogen. Carbon dioxide and the like .. after which the shell 11 is hot-sealed

will. In this way, packaging of the polyglycolic acid suture material is obtained without a vacuum. The sealed envelope 11 is then removed from the sterile room 22 and pushed into the folded plastic film 23. The film 23 is sealed around the casing 11 with a sealing seam 24 tapering to a point on one side, so that an outer peelable casing 25 is formed which encloses the inner casing 11 tightly. A variety of materials are suitable for the outer strippable cover 25, e.g. B. many

Plastics, papers and metal foils can be used for this purpose. One for the outer A particularly suitable material for sheath 25 is disclosed in U.S. Patent No. 2,949,181. The double-wrapped suture package is then placed in

introduced an ethylene oxide furnace, wherein the outer surfaces of the shell 11, the inner surface of the shell 25 and the space between these sheaths is sterilized. The ethylene oxide vapors penetrate through the

outer shell 25 therethrough. The mechanism of this Sterilization is known and is described in US Pat. No. 2,917K7K in one. After completion Sterilization gives you a shelf-stable suture package, except for the outer surface of the liner 25 is completely sterile. This Pack is particularly suitable for providing sterile sutures for surgical purposes.

The sequence and the sequence of the individual steps of the process described above after the crimping can be varied somewhat without affecting the characteristics of the finished packaged product. For example, the suture material 12 and the sheath 11 can be sterilized separately and only assembled in the sterile room 22. Alternatively, the suture material 12 in the casing II can be vacuum dried prior to sterilization, with the exception that a subsequent drying step is required at that time if moisture is absorbed by the suture material during the sterilization process. Furthermore, the suture material 12 can be dried before it is inserted into the casing 11. Of course, many sterilization techniques, additional sterilization, x- rays or y-rays and the like can be used. The preferred sterilization process, however, is carried out with the aid of ethylene oxide.

The polyglycolic acid suture itself came from have any suitable shape and e.g. B. one of several load braided strand or a single thread l-! s can further be firmly connected with needles, dyed excessive or otherwise traded in a known manner.

In the following table I are given again the values that the influence of different bearings conditions on the tensile strength and knot strength as well as the in vivo strength of polyglycol sutures acid in packs produced according to the invention.

Table I.

Influence of different storage conditions on the strength properties of sutures

Polyglycolic acid

l.agcrzcit Seam- Γ-esligkeit- received
Kcslig- 7 days in vivo properties 15 days after itation
received medium
size properties kcit Implar
train after Inipia
train Fixed wedge L.ageriingshcilingiingcn (Months) train "/ 0 strength tation
received strength "/" strength kg / cm- strength kg / cm ¹ 0 kg / cm ² - - 24.S C, 50% relative humidity 3 3-0 99 4214 1981 68 ability (r. L.) 6th 3-0 6279 95 4543 - 1344 88 3-0 6202 4543 108 1750 0 5915 - 108 - 35.5 C, humid ambient air 3 3-0 104 4214 1981 48 ability (U. L.) 6th 3-0 6279 96 3566.5 - 945 69 0 3-0 6510 4368 85 1365 3 3-0 6027 104 4214 104 1981 62 Department store 6th 3-0 6297 95 4543 1225 81 0 3-0 6552 4774 108 1603 .23 3-0 5971 98 4214 113 1981 87 SS S C 10 ° / "r L .70 3-0 6279 94 4599 1715 28 1.4 3-0 6146 88 3717 109 553 7th 0 3-0 5887 __ 2856 88 133 3 1-0 5544 99 3444 68 938 82 -14 sr SO ¹ V _n r L 6th 1-0 4991 100 3689 770 98 0 1-0 4928 3584 107 917 3 1-0 4991 98 3444 104 938 83 35 5 ⁰ C UL 6th 1-0 4991 97 3689 777 74 0 1-0 4886 3647 107 693 3 1-0 4844 98 3444 106 938 89 Department store 6th 1-0 4991 97 3647 833 93 0 1-0 4956 3731 106 875 .23 1-0 4816 101 3444 108 938 82 55 5 ° C 10%, r L .70 1-0 4991 91 3549 766.5 38 1.4 1-0 5047 87 2975 103 357 6th 1-0 4564 1715 86 60.9 4333 50

The values are reported as a percentage of the original strength that was obtained. Which Explanations relating to tensile strength and knot strength are intended to express that on On day zero of the storage time, the tensile strength and knot strength of a packaged suture were measured would. The tensile strength and knot strength increases as the body progresses Storage time measured at prescribed time intervals and with the corresponding white for this strength compared on day zero, so the "percentage of strength retained" is based on this Way is determined. When determining the in-vivo strength, a was packaged according to the invention Sutures (without storage time) on day zero de

609 627/36

Storage time implanted in a rabbit and 7 to Left in the same for 15 days, after which the rabbit was oiled and the Nablmittcl removed. The tensile strength of the food removed was then measured and this measure used as a standard measure. ! As the storage period progressed, sutures were placed at the prescribed line spacing, as above described, implanted in rabbits and measured the strength of these sutures after 7 or 15 days. The strength measured in each case was compared with the strength wedge, that with the Nonnnahl on day zero was obtained. The value determined in this way is given in "percent of the strength obtained".

The values in Table I show the influence of various storage conditions on tensile strength and knot strength as well as the in vivo strength of NaIumittcln sizes 3 to 0 and 1 to 0. The resulting wedge for both tensile and knee strength and in vivo strength is generally satisfactory under all conditions except at 55.5 ° C. and a relative humidity of 10%. The values / clearly indicate the extremely rapid destruction of the strength of the seam material which is to be expected even in packages according to the invention when the relative humidity outside the package is low but the temperature both inside and outside the package is high.

Table Influence of the Environment Before Packing

The Werie / own also that at low temperatures! and high external relative humidity a sufficient Lageningsrühigkeit can be obtained, [-.me analysis of this Werle / Eigl. that the package makes contact of the seam material inside the package with the moisture outside the package, either in a high humidity environment or in an environment; low humidity sufficiently prevented. But what if the storage temperatures are increased, but if the suture fluid resistance and in particular the m-vivo fluid resistance of the suture material deteriorate more quickly ? It is a fact that the packaging prevents the lcuchligkcils / utnll to the contents of the packaging. The values in tables / own. where such rapid disintegration of the properties of the suture material occurs when stored at a temperature of 55 5 C. Many of these values are in fig. 4a (strength with straight pull) and in Fig. 4b (Ziig-'cstigkeit after I 5lägigcm Finset / s in the living v) rgan, _{smus) is} reproduced, and from this table, the importance isi clear that Nahlmittcl to '', ^"C", "" point of Verpackcns in the packaging "After the lightening! rock / u reverberate when the near- • nittclfcst.gkct over a longer period of storage at, ^{e :;} temperatures like 55.5 C are maintained

^Nai " ^miiid "

Storage conditions

Location rzc il

(Weeks)

Condition of the near limit before packing

37.8 ⁰ C,

100%

r. L.

55.5 ' C.

10 »/»
r. L.

37.8 ° C,
100%
r. L.

10%

37.8 ° C, 100% r. L.

55.5 ° C,

10%

0 i

3
6th

3
6th

0
1
3
6th

0
1
3
6th

0 1 3 6th

0 1 3 6th

Nalii small size

'Heated under vacuum at 86.7 "C for 1 hour and then exposed to 50% RH for 24 hours

heated at 86.7'C for 1 hour under vacuum and then in an environment with 20 to 30% r. L. brought

3d heated to 86.7 ° C1 hour and then immediately placed in a dessicator until packaging

a - ^ Seams due to insufficient strength b - Nah.mi.te. decomposed and d «^ lb nicS

3—0 3—0 3—0 3—0

3—0 3—0 3—0 3—0

3—0 3—0 3—0 3—0 3—0 3—0 3—0 3-0 3-0

3—0 3—0 3—0 3—0

3—0 3—0 3—0 3—0

after ι N ;!

kg / cm ²

received

tensile strenght

50! 2
4760
4760
4438

5012
3808

5012
4851
4830
4669

5012

4200

95 95
88

76

97 96 93

84 25th

95 91 91

95 91 91

Liability

kg / cm- '

3J74

3332
2940
3269

3374
2898

3374
3318
3192
3038

3374 3094

931

3374 3402 3136 3192

3374 3192 3136 3192

• lwöchiger La _delay not umersucht;

in-vivo received I -'igcii.sc adhere Zig-
fcsligkcit "/" received
csligkeit Train-
strength kg / eni- 71 525 68 99 371 39 87 357 . 97 203 0 525 ■ - 86 0 ■ - - a - a 104 .-_ 525 107 98 546 55 95 560 » 90 287 3 525 0 92 16.45 _ 28 0 54 525 107 101 280 145 93 560 . 95 763 36 525 78 95 189 64 93 406 95 336

The values in Table II allow a study of the animal / wipe conditions to which the nalilmillel / wipe is exposed to the drying and sealing of the package according to this standard. In a bag, the dried suture was exposed to an environment at room temperature but a 50 "/" IgCII relative humidity for 24 hours. The envelope containing the nutrient was then sealed and packaged in an outer, accessible sleeve and at 55.5 ° C and a relative humidity Humidity of K) "/ ,, stored. After only one week of storage under these conditions, the food supplies practically no in vivo oil ^; ease, while at the same time his tensile strength has been greatly reduced.

In the other case, a dried suture was used Stored in a container at room temperature and in a bypass that is 20 to 30 "relative humidity hold The food was then packaged as above. Same rapid destruction of seam strength was used in an intermediate bearing 50 "/" relative humidity as in the above I all also observed.

Finally, a dried suture was made from removed from the drying oven and immediately placed in a desiccator, where it is up / around sealing in the pack remained. As can be seen from the 1 · 'i g. 4a and 4b can be seen, the supply and node

The sand wedge properties of the Nahlmiltcl have been retained for a sufficient period of time after storage at 55.5 ° C. for 6 weeks. Line storage for 1 week at 55.5 C and 10 ¹ Vn relative humidity is equivalent to storage for one year at 22 ¹ C and ambient humidity.

The above results / own clear do correctness, that Once dry, store sutures in a dry state until they are in a waterproof packaging is sealed. Even if you look at the dried sutures just a lot briefly exposes the general conditions was surprisingly in some lallen get an extremely rapid destruction of the seam means strength if these seam means packaged on it and have been lurked, especially if storage takes place at high temperatures that cause the unwanted linlluss on the polyglycolic acid suture millel accelerate.

Table III shows the values which compare the storage capacities of the packaging according to this invention with those of a typical packaging which is widely used for catgul sutures, with measurements being made under various storage conditions. The catgut packaging to which reference is made is that which is described in the USA.-Palentschrift 2 ^l > 17 H7 ".

Table III

Comparison of the shelf life wedge of the packaging after packaging with that of a typical, for

Caigut seam center! used packaging

warehouse Warehouse- Seam means Nahimitlel- I estigkcits- received in-vivo received conditions 7CU diameter l.sehaflen I estigkcil (properties strength "/ N after 15 days packing material train implantation 37.8 C, (Days I Catgut well strength 95 train 74 100 " ₀ 0 0.3022 kg / cni- 96 strength 104 r. L. 7th 0.3200 4179 89 kg / cm ² 43 Scotch-Pak 14th 0.3200 3990 84 578.9 59 21 0.3225 4011 - 427 - 37.8 ° C, 42 Polyglycol 0.3225 3703 96 602 81 100% 0 acid 0.2565 3537.8 87 248.5 117 r. L. 7th 0.3501 5509 95 342.3 53 According to the invention 14th 0.2666 5313 96 840 63 pack 21 0.2501 4774 679 - 55.5 ° C, 42 Catgut 0.2501 5229 84 980 51 50% 0 0.3022 5313 85 445.2 69 r. L. 7th 0.3225 4179 86 532 24 Scotch pak 14th 0.3225 3535 79 578.9 56 21 0.3277 3563 - 297.5 - 55.5 ° C, 42 Polyglycol 0.3277 3591 96 402.5 88 50% 0 acid 0.2565 3322.2 90 139.3 110 r. L. 7th 0.2501 5509 97 326.2 67 According to the invention 14th 0.2666 5313 96 840 58 pack 21 0.2641 5019 749 42 0.2641 5362 924 5278 560 485.8

Values from Table III are shown in FIGS. 5a and drawn. As can be seen from these figures, in both storage conditions examined. 37.8 ° C and 100% relative humidity, 5 ⁰ C at 10% relative humidity;

those of catgut sutures, and they seem to be a little better at that.

The ones shown in FIGS. 5a and 5b clearly indicate the capability of the packaging according to c Invention again, absorbable surgical! Polyglycolic acid medium stable for a long time able to hold.

For this purpose 4 sheets of drawings

Claims (3)

Patent claims: 1. Process for the production of absorbable sutures from polydycolic acid containing Packs, characterized in that a is inserted), the suture of polyglycolic acid in a container made of a material that _{| o} which is practically impermeable to water vapor, b) the suture and the container are sterilized, c) Virtually all of the water in the suture is removed from polyglycolic acid, d) the suture material dried according to c) before closing the packaging in a practical dry environment is brought and e) practically the entire gas content of the container is evacuated and the container is then airtight is locked. 2. The method according to claim 1, characterized in that in step e) the gas content of the container after removal is replaced by gas that does not react with the polyglycolic acid and practical is moisture-free, and then the container is hermetically sealed. 3. The method according to claim 1 or 2, characterized in that in step b) the sterilization of suture material and container by treatment with a gas whose active ingredient is ethylene oxide and which has the moisture content of the environment, for at least 4 hours at a temperature of about 29 to 32 ' ³ C and a pressure of about 0.35 to 1.05 atm.