"JSC Poltava Medical Glass Factory"

Ampoules

JSC "Poltava Medical Glass Factory" manufactures primary packaging for medicinal products: ampoules of type IP (syringe filling), type VO (vacuum filling) in accordance with TU U 00480945-005-96.

Ampoules are made with a capacity of 1 ml, 2 ml, 3 ml, 5 ml, 10 ml and 20 ml. IP-type ampoules with and without a coloured break ring, with one-point-cut (OPC) according to international standards ISO 9187-1 and ISO 9187-2. At the request of the consumer, it is possible to mark the ampoules with coding rings.

The break ring or one-point-cut (OPC) are applied to the ampoule to open the ampoule with the drug without the use of auxiliary equipment. Ampoules can be made without a ring or break point, depending on the customer's order. In this case, the packaging of the ampoules with the drug should be equipped with auxiliary devices for incision of glass.

The break ring or incision provides the breaking force of the ampoule in a given range. Compliance of the breaking force of the ampoules of JSC “Poltava Medical Glass Factory” with the specified values is controlled by a modern tester of the German company "PHARMA TEST".

Ampoules are produced on the modern technological equipment of the company "Moderne Mecanique", France. The MM30-LA502 ampoule production lines provide a closed ampoule production cycle

- the "ROBOGLASS" systems for automatic loading of glass tubes into the MM30 semi-automatic machine of the LA502 line eliminate the human factor from the process reducing the risk of their contamination and breakage;

- the production of ampoules on a semi-automatic machine MM30 is carried out using the technology of fire forming from a glass tube with the help of burners that work on a gas-air-oxygen mixture;

- automatic calibration of the ampoules according to the main geometric dimensions is carried out in 100% volume to ensure compliance of the ampoules with the requirements of the drawing and regulatory documentation;

- annealing of ampoules is carried out on a line LA502 in an electric furnace, which has two annealing zones to remove residual stress in the glass and obtain high indicators of ampoule heat resistance;

- to ensure the cleanliness of the surface of the ampoules, packaging is carried out in modern containers made of cardboard or polypropylene in rooms separated from those where the ampoules are produced;

- the boxes with ampoules are formed on flat wooden pallets into transport bags with subsequent packaging of the bags into shrink film on modern European equipment of the company "Messersi", Italy.

Ampoules can be transported by any type of vehicle in accordance with the transportation rules applicable to each type of transport.

dimensions	execution
	0	1
d1	10,75 ± 0,15
d2	6.5 ± 0,5
d3	8.5 ± 0,5
d4	6.2 ± 0,3	6.0 ± 0,35
d5	7,0 ± 1	8,0 ± 1
d6	9,0 ± 0,8
d7	10,0 ±1
h1	60 ± 1
h2	60 ± 1	67 ± 1
h3	70 ± 1
h4	28,5 ± 0,5	25,5 ± 0,5
h5	47 ± 2
h6 min	23	21
h7 max	34,5	32,5
h8 max	4,5
h9 max	36,5	34,5
e	1 ± 0,5
R	1 ± 0,5
S1	0,5 ± 0,03
S2	0,37 ± 0,05
S3 min	0,3
S4	0,7 ± 0,1
S5	from 0,1 to 0,25
f	0.6

dimensions	execution
	0	1
d1	10,75 ± 0,15
d2	6.5 ± 0,5
d3	8.5 ± 0,5
d4	6.2 ± 0,3	6.0 ± 0,35
d5	7,0 ± 1	8,0 ± 1
d6	9,0 ± 0,8
d7	10,0 ±1
h1	72 ± 1
h2	72 ± 1	79 ± 1
h3	83 ± 1
h4	37,5 ± 0,5
h5	57 ± 2
h6 min	33
h7 max	44,5
h8 max	4,5
h9 max	46,5
e	1 ± 0,5
R	1 ± 0,5
S1	0,5 ± 0,03
S2	0,37 ± 0,05
S3 min	0,3
S4	0,7 ± 0,1
S5	from 0,1 to 0,25
f	0.6

dimensions	execution
	0	1
d1	12,75 ± 0,15
d2	6.5 ± 0,5
d3	8.5 ± 0,75	8.5 ± 0,5
d4	6.2 ± 0,3	6.0 ± 0,35
d5	8,0 ± 1
d6	11,2 ± 0,8	10.7 ± 0,8
d7	10,5 ±1
h1	75 ± 1
h2	82 ± 1
h3	89 ± 1
h4	39,5 ± 0,5
h5	62 ± 2
h6 min	34
h7 max	46,5
h8 max	5,0
h9 max	48,5
e	1 ± 0,5
R	1.5 ± 0,5
S1	0,5 ± 0,03
S2	0,37 ± 0,05
S3 min	0,3
S4	0,7 ± 0,1
S5	from 0,1 to 0,25
f	0.8

dimensions	execution
	0	1
d1	14,75 ± 0,15
d2	7.0 ± 0,5
d3	9.5 ± 0,5	9.0 ± 0,5
d4	7.0 ± 0,5	7.0 ± 0,35
d5	8,5 ± 1	9,0 ± 1
d6	11,2 ± 1	12.2 ± 1
d7	12,0 ±1
h1	83 ± 1
h2	83 ± 1	90 ± 1
h3	95 ± 1
h4	46,5 ± 0,5
h5	68 ± 2
h6 min	41
h7 max	54,0
h8 max	5,5
h9 max	56,5
e	1 ± 0,5
R	1.5 ± 0,5
S1	0,55 ± 0,03
S2	0,4 ± 0,05
S3 min	0,4
S4	0,7 ± 0,15
S5	from 0,1 to 0,25
f	1.0

dimensions	execution
	0	1
d1	17,75 ± 0,2
d2	7.5 ± 0,5
d3	9.5 ± 0,75	9.5 ± 0,5
d4	7.75 ± 0,6	7.1 ± 0,35
d5	9,0 ± 1	9,5 ± 1
d6	13,0 ± 1
d7	13,5 ±1
h1	102 ± 1
h2	109 ± 1
h3	112 ± 1
h4	62,0 ± 1
h5	87 ± 2
h6 min	54
h7 max	70,0
h8 max	6,0
h9 max	72,5
e	1.25 ± 0,75
R	1.5 ± 0,5
S1	0,6 ± 0,04
S2	0,47 ± 0,05
S3 min	0,4
S4	0,8 ± 0,15
S5	from 0,1 to 0,25
f	1.0

dimensions	execution
	0	1
d1	22,5 ± 0,2
d2	8.5 ± 0,5
d3	12.0 ± 1
d4	7.8 ± 0,8	7.8 ± 0,5
d5	11,0 ± 1
d6	14,0 ± 1
d7	13,5 ±1
h1	113 ± 1
h2	120 ± 1
h3	126 ± 1
h4	76,0 ± 1.3
h5	100 ± 2
h6 min	64
h7 max	84,5
h8 max	6,5
h9 max	87
e	1.5 ± 1
R	2.0 ± 0,5
S1	0,7 ± 0,04
S2	0,5 ± 0,05
S3 min	0,5
S4	1,0 ± 0,2
S5	from 0,1 to 0,25
f	1.2


capacity, ml	D	d	H	h±2	h1	S±0.05	S1±0.05	S2±0.06	f
1	9,35±0.15	2,7±0.3	62±1	55	25±1	0,5	0,3	0,3	1,2
2	10,75±0.15	2,7±0.3	69±1	60	35±1	0,5	0,3		1,2
5	14,0±0.15	3,8±0.5	90⁺¹	80	50⁺¹	0,55	0,4		1,5
10	15,75±0.2	3,75±0.5	117±1	107	71±1	0,6	0,5		1,5

	ampoules of the type IP with a capacity of 1 ml, form C, with a white break ring, made of USP-1 colourless glass, according to I TU U 00480945-005-96 *"Ampoule IP-1С cbr USP-1 cl TU U 00480945-005-96"*
	ampoule of the IP type with a capacity of 1 ml, form C, execution 1, with a white break ring, made of USP-1 light-protective glass, according to TU U 00480945-005-96 (dimensions according to ISO 9187-1): "Ampoule IP-1C1 cbr-amber TU U 00480945-005-96"
	ampoule of the IP type with a capacity of 5 ml, form D (closed), with a white break ring, made of light-protective glass of the FIOLAX brand, according TU U 00480945-005-96 (dimensions according to ISO 9187-1): "Ampoule IP-5D1 cbr-amber TU U 00480945-005-96"
	Ampoule of the IP type with a capacity of 20 ml, form C, with a white one-point-cut (OPC), made of USP-1 colourless glass, according to TU U 00480945-005-96 Ampoule IP-20C opc USP-1 TU U 00480945-005-96"
	Аmpoule of the IP type with a capacity of 1 ml, form C, with a yellow break ring, made of USP-1 colourless glass, according to TU U 00480945-005-96: "Ampoule IP-1C cbr-04 USP-1 TU U 00480945-005-96"
	Ampoule of the IP type with a capacity of 10 ml, form C, with a red one-point-cut (OPC), with blue and green coding rings made of USP-1 colourless glass, according to TU U 00480945-005-96: "Ampoule IP-10C opc-03 KK2/26 USP-1 TU U 00480945-005-96"

PRODUCTIS