Fundamentals of General and Pharmaceutical Hygiene - Dykyi I.L. 2003
Appendices
Table 1 Maximum Water vapor pressure at various temperatures (mmHg)
|
Whole degrees |
Tenths of a degree |
|||||||||
|
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
|
|
-5 |
3,16 |
3,13 |
3,11 |
3,09 |
3,06 |
3,04 |
3,02 |
2,99 |
2,97 |
2,95 |
|
-4 |
3,40 |
3,38 |
3,35 |
3,33 |
3,30 |
3,28 |
3,23 |
3,23 |
3,21 |
3,18 |
|
-3 |
3,67 |
3,64 |
3,62 |
3,59 |
3,56 |
3,53 |
3,51 |
3,48 |
3,46 |
3,43 |
|
-2 |
3,95 |
3,92 |
3,89 |
3,86 |
3,84 |
3,81 |
3,78 |
3,75 |
3,72 |
3,70 |
|
-1 |
4,26 |
4,22 |
4,19 |
4,16 |
4,13 |
4,10 |
4,07 |
4,04 |
4,01 |
3,98 |
|
0 |
4,58 |
4,61 |
4,65 |
4,68 |
4,72 |
4,75 |
4,78 |
4,82 |
4,86 |
4,89 |
|
1 |
4,93 |
4,96 |
5,00 |
5,03 |
5,07 |
5,11 |
5,14 |
5,18 |
5,22 |
5,26 |
|
2 |
5,29 |
5,33 |
5,37 |
5,41 |
5,45 |
5,49 |
5,52 |
5,56 |
5,60 |
5,64 |
|
3 |
5,68 |
5,72 |
5,77 |
5,81 |
5,85 |
5,89 |
5,93 |
5,97 |
6,02 |
6,06 |
|
4 |
6,10 |
6,14 |
6,19 |
6,23 |
6,27 |
6,32 |
6,36 |
6,41 |
6,45 |
6,50 |
|
5 |
6,54 |
6,59 |
6,64 |
6,68 |
6,73 |
6,78 |
6,82 |
6,87 |
6,92 |
6,96 |
|
6 |
7,01 |
7,06 |
7,11 |
7,16 |
7,21 |
7,26 |
7,31 |
7,36 |
7,41 |
7,46 |
|
7 |
7,51 |
7,56 |
7,62 |
7,67 |
7,72 |
7,78 |
7,83 |
7,88 |
7,94 |
7,99 |
|
8 |
8,04 |
8,10 |
8,16 |
8,21 |
8,27 |
8,32 |
8,38 |
8,44 |
8,49 |
8,55 |
|
9 |
8,62 |
8,67 |
8,73 |
8,79 |
8,84 |
8,90 |
8,96 |
9,02 |
9,09 |
9,15 |
|
10 |
9,21 |
9,27 |
9,33 |
9,40 |
9,46 |
9,52 |
9,58 |
9,65 |
9,71 |
9,78 |
|
11 |
9,84 |
9,91 |
9,98 |
10,04 |
10,11 |
10,18 |
10,24 |
10,31 |
10,38 |
10,45 |
|
12 |
10,52 |
10,59 |
10,66 |
10,73 |
10,80 |
10,87 |
10,94 |
11,01 |
11,08 |
11,06 |
|
13 |
11,23 |
11,30 |
11,38 |
11,45 |
11,53 |
11,60 |
11,68 |
11,76 |
11,83 |
11,91 |
|
14 |
11,99 |
12,06 |
12,14 |
12,22 |
12,30 |
12,38 |
12,46 |
12,54 |
12,62 |
12,71 |
|
15 |
12,79 |
12,87 |
12,95 |
13,04 |
13,12 |
13,20 |
13,29 |
13,38 |
13,46 |
13,55 |
|
16 |
13,63 |
13,72 |
13,81 |
13,90 |
13,99 |
14,08 |
14,17 |
14,26 |
14,35 |
14,14 |
|
17 |
14,53 |
14,62 |
14,72 |
14,81 |
14,90 |
15,00 |
15,09 |
15,19 |
15,28 |
15,38 |
|
18 |
15,48 |
15,58 |
15,67 |
15,77 |
15,87 |
15,97 |
16,07 |
16,17 |
16,27 |
16,37 |
|
19 |
16,48 |
16,58 |
16,67 |
16,79 |
16,89 |
17,00 |
17,10 |
17,21 |
17,32 |
17,43 |
|
20 |
17,54 |
17,64 |
17,75 |
17,86 |
17,97 |
18,08 |
18,20 |
18,31 |
18,42 |
18,54 |
|
21 |
18,65 |
18,88 |
19,00 |
19,11 |
19,23 |
19,35 |
19,23 |
19,47 |
19,59 |
19,71 |
|
22 |
19,83 |
19,95 |
20,07 |
20,19 |
20,32 |
20,44 |
20,56 |
20,69 |
20,82 |
20,94 |
|
23 |
21,07 |
21,20 |
21,32 |
21,45 |
21,58 |
21,71 |
21,84 |
21,98 |
22,10 |
22,24 |
|
24 |
2238 |
2251 |
2265 |
2278 |
2292 |
2306 |
2320 |
2334 |
2348 |
2362 |
|
25 |
23,76 |
23,90 |
24,04 |
24,18 |
24,33 |
24,47 |
24,62 |
24,76 |
24,91 |
25,06 |
|
26 |
25,21 |
25,36 |
25,66 |
25,81 |
25,81 |
25,96 |
26,12 |
26,27 |
26,43 |
26,58 |
|
27 |
26,74 |
26,90 |
27,06 |
27,21 |
27,37 |
27,54 |
27,70 |
27,86 |
28,02 |
28,18 |
|
28 |
28,35 |
28,51 |
28,68 |
28,85 |
29,02 |
29,18 |
29,35 |
29,52 |
29,70 |
29,87 |
|
29 |
30.04 |
30,22 |
30,39 |
30,57 |
30,74 |
30,92 |
31,10 |
31,28 |
31,46 |
31,64 |
|
30 |
31,82 |
32,01 |
32,19 |
32,38 |
32,56 |
32,75 |
32,93 |
33,12 |
33,31 |
33,50 |
|
31 |
33,70 |
33,89 |
34,08 |
34,28 |
34,47 |
34,67 |
34,86 |
35,06 |
35,26 |
35,46 |
Table 2 Air velocity below 1 m/s adjusted for Temperature corrections
|
Air temperature, °C |
|||||||
|
H/Q |
10 |
12,5 |
15 |
17,5 |
20 |
20,5 |
25 |
|
0,27 |
- |
- |
- |
- |
0,041 |
0,047 |
0,051 |
|
0,28 |
- |
- |
- |
0,049 |
0,051 |
0,061 |
0,070 |
|
0,29 |
0,041 |
0,050 |
0,051 |
0,060 |
0,076 |
0,085 |
0,089 |
|
0,30 |
0,051 |
0,060 |
0,065 |
0,073 |
0,082 |
0,091 |
0,101 |
|
0,31 |
0,061 |
0,070 |
0,079 |
0,088 |
0,098 |
0,107 |
0,116 |
|
0,32 |
0,076 |
0,085 |
0,094 |
0,104 |
0,113 |
0,124 |
0,136 |
|
0,33 |
0,091 |
0,101 |
0,110 |
0,119 |
0,128 |
0,140 |
0,158 |
|
0,34 |
0,107 |
0,115 |
0,129 |
0,139 |
0,148 |
0,160 |
0,196 |
|
0,35 |
0,127 |
0,136 |
0,145 |
0,154 |
0,167 |
0,180 |
0,196 |
|
0,36 |
0,142 |
0,151 |
0,165 |
0,179 |
0,179 |
0,192 |
0,206 |
|
0,37 |
0,163 |
0,172 |
0,181 |
0,198 |
0,212 |
0,226 |
0,240 |
|
0,38 |
0,183 |
0,197 |
0,210 |
0,222 |
0,239 |
0,149 |
0,266 |
|
0,39 |
0,208 |
0,222 |
0,232 |
0,244 |
0,257 |
0,174 |
0,293 |
|
0,40 |
0,229 |
0,242 |
0,256 |
0,269 |
0,287 |
0,305 |
0,323 |
|
0,41 |
0,254 |
0,267 |
0,282 |
0,299 |
0,314 |
0,330 |
0,349 |
|
0,42 |
0,280 |
0,293 |
0,311 |
0,325 |
0,343 |
0,361 |
0,379 |
|
0,43 |
0,320 |
0,324 |
0,342 |
0,356 |
0,373 |
0,392 |
0,410 |
|
0,44 |
0,340 |
0,354 |
0,368 |
0,385 |
0,401 |
0,417 |
0,445 |
|
0,45 |
0,366 |
0,351 |
0,398 |
0,412 |
0,428 |
0,449 |
0,471 |
|
0,46 |
0,396 |
0,415 |
0,429 |
0,446 |
0,465 |
0,483 |
0,501 |
|
0,47 |
0,427 |
0,445 |
0,464 |
0,482 |
0,500 |
0,518 |
0,537 |
|
0,48 |
0,468 |
0,481 |
0,499 |
0,513 |
0,531 |
0,551 |
0,572 |
|
0,50 |
0,539 |
0,557 |
0,571 |
0,589 |
0,604 |
0,622 |
0,540 |
|
0,51 |
0,574 |
0,593 |
0,607 |
0,628 |
0,648 |
0,666 |
0,684 |
|
0,52 |
0,615 |
0,633 |
0,644 |
0,665 |
0,683 |
0,701 |
0,720 |
|
0,53 |
0,656 |
0,674 |
0,688 |
0,705 |
0,724 |
0,742 |
0,760 |
|
0,54 |
0,696 |
0,715 |
0,729 |
0,746 |
0,764 |
0,783 |
0,801 |
|
0,55 |
0,737 |
0,755 |
0,770 |
0,790 |
0,807 |
0,827 |
0,844 |
|
0,56 |
0,788 |
0,801 |
0,815 |
0,833 |
0,851 |
0,867 |
0,884 |
|
0,57 |
0,834 |
0,832 |
0,867 |
0,882 |
0,898 |
0,915 |
0,933 |
|
0,58 |
0,879 |
0,898 |
0,912 |
0,929 |
0,911 |
0,999 |
0,972 |
|
0,59 |
0,930 |
0,943 |
0,957 |
0,971 |
0,985 |
1,001 |
1,018 |
|
0,60 |
0,981 |
0,994 |
1,008 |
1,022 |
1,003 |
1,014 |
1,056 |
Table 3 Coefficients for reducing air volume to normal conditions
|
Temperature, °C |
1+at° 1 + 0,003677 t° |
Barometric pressure, mmHg |
B |
|
760 |
|||
|
-4 |
0,985 |
742 |
0,976 |
|
-3 |
0,989 |
743 |
0,978 |
|
-2 |
0,993 |
744 |
0,979 |
|
-1 |
0,996 |
745 |
0,981 |
|
0 |
1,000 |
746 |
0,982 |
|
1 |
1,004 |
747 |
0,983 |
|
2 |
1,007 |
748 |
0,984 |
|
3 |
1,011 |
749 |
0,986 |
|
4 |
1,015 |
750 |
0,987 |
|
5 |
1,018 |
751 |
0,988 |
|
6 |
1,022 |
752 |
0,989 |
|
7 |
1,026 |
753 |
0,991 |
|
8 |
1,028 |
754 |
0,992 |
|
9 |
1,033 |
755 |
0,993 |
|
10 |
1,037 |
756 |
0,995 |
|
11 |
1,04 |
757 |
0,996 |
|
12 |
1,044 |
758 |
0,997 |
|
13 |
1,048 |
759 |
0,999 |
|
14 |
1,051 |
760 |
1,000 |
|
15 |
1,055 |
761 |
1,001 |
|
16 |
1,059 |
762 |
1,003 |
|
17 |
1,062 |
763 |
1,004 |
|
18 |
1,066 |
764 |
1,005 |
|
19 |
1,07 |
765 |
1,007 |
|
20 |
1,073 |
766 |
1,008 |
|
21 |
1,077 |
767 |
1,009 |
|
22 |
1,081 |
768 |
1,011 |
|
23 |
1,084 |
769 |
1,012 |
|
24 |
1,088 |
770 |
1,013 |
|
25 |
1,092 |
771 |
1,015 |
|
26 |
1,095 |
772 |
1,016 |
|
27 |
1,099 |
773 |
1,017 |
|
28 |
1,103 |
774 |
1,018 |
|
29 |
1,106 |
775 |
1,02 |
|
30 |
1,11 |
776 |
1,021 |
|
31 |
1,114 |
777 |
1,022 |
|
32 |
1,117 |
778 |
1,024 |
|
33 |
1,121 |
779 |
1,025 |
|
34 |
1,125 |
780 |
1,026 |
Table 4 Carbon dioxide content in the air relative to the volume of air required to decolorize 20 mL of a 0.005% sodium carbonate solution
|
Air volume, mL |
Carbon dioxide content, % |
Air volume, mL |
Carbon dioxide content, % |
|
85 |
0,317 |
260 |
0,144 |
|
90 |
0,310 |
270 |
0,138 |
|
95 |
0,298 |
280 |
0,134 |
|
100 |
0,286 |
290 |
0,130 |
|
110 |
0,270 |
300 |
0,128 |
|
120 |
0,259 |
310 |
0,123 |
|
130 |
0,235 |
320 |
0,120 |
|
140 |
0,228 |
330 |
0,116 |
|
150 |
0,216 |
340 |
0,112 |
|
160 |
0,209 |
350 |
0,108 |
|
170 |
0,201 |
360 |
0,102 |
|
180 |
0,195 |
370 |
0,098 |
|
190 |
0,190 |
380 |
0,093 |
|
200 |
0,184 |
390 |
0,089 |
|
210 |
0,174 |
400 |
0,085 |
|
220 |
0,168 |
410 |
0,081 |
|
230 |
0,162 |
420 |
0,076 |
|
240 |
0,156 |
430 |
0,073 |
|
250 |
0,150 |
440 |
0,068 |
|
450 |
0,063 |
Table 5 Maximum allowable concentrations (MAC) of harmful substances in the working zone air (excerpt from GOST 12.1.005-76)
|
Item No. |
Substance name |
MAC value, mg/m3 |
Predominant state in air under industrial conditions |
Hazard Class |
|
1 |
n-Aminobenzenesulfaguanidine (sulgin) |
1 |
A |
2nd |
|
2 |
2-(Aminobenzenesulfamido)-4,6-dimethylpyrimidine (sulfadimezin / sulfadimidine) |
1 |
A |
2nd |
|
3 |
n-Aminobenzenesulfacetamide (sulfacyl) |
1 |
A |
2nd |
|
4 |
2-(n-Aminobenzenesulfamido)-thiazole (norsulfazole) |
1 |
A |
2nd |
|
5 |
Ammonia |
20 |
П |
4th |
|
6 |
Acetylsalicylic acid (aspirin) |
0,5 |
A |
2nd |
|
7 |
Benzylpenicillin |
0,1 |
A |
2nd |
|
8 |
Bromine |
0,5 |
П |
2nd |
|
9 |
Diethyl ether (ethyl ether) |
300 |
П |
4th |
|
10 |
Iodine |
1 |
П |
2nd |
|
11 |
Camphor |
3 |
П |
3rd |
|
12 |
Boric acid |
10 |
N + a |
3rd |
|
13 |
5 |
П |
2nd |
|
|
14 |
Caffeine base |
0,5 |
A |
2nd |
|
15 |
Caffeine sodium benzoate (calculated as caffeine base) |
0,5 |
A |
2nd |
|
16 |
Levomycetin (chloramphenicol) |
1 |
A |
2nd |
|
17 |
Microbial lipases |
1 |
A |
2nd |
|
18 |
Manganese (calculated as Mn2O) |
0,3 |
A |
2nd |
|
19 |
Nicotinamide |
1 |
A |
2nd |
|
20 |
Nicotinic acid |
1 |
A |
2nd |
|
21 |
Polymyxin M |
0,1 |
A |
2nd |
|
22 |
Rifampicin |
0,02 |
A |
1st |
|
23 |
Metallic mercury |
0,01/0,005* |
П |
1st |
|
24 |
Mercuric chloride (corrosive sublimate) |
0,1 |
A |
4th |
|
25 |
D-Sorbitol |
10 |
A |
4th |
|
26 |
Ethyl alcohol |
1000 |
П |
4th |
|
27 |
Streptomycin |
0,1 |
A |
1st |
|
28 |
n-Sulfaminophenylaminomethylenesulfonate sodium (white streptocide) |
1 |
A |
2nd |
|
29 |
Tetracycline |
0,1 |
A |
2nd |
|
30 |
Trichodermin |
0,1 |
A |
1st |
|
31 |
Carbon monoxide |
20 |
П |
4th |
|
32 |
Phenacetin |
0,5 |
A |
2nd |
|
33 |
1-phenyl-2,3-dimethyl-4-dimethylaminopyrazolone (amidopyrine) |
0,5 |
A |
2nd |
|
34 |
1-phenyl-2,3-dimethyl-4-methylaminopyrazolone-5-N-methanesulfonate sodium (analgin) |
0,5 |
A |
2nd |
|
35 |
Phenol+ |
0,3 |
П |
2nd |
|
36 |
Formaldehyde |
0,5 |
П |
2nd |
|
37 |
N-5-nitro-2-furylideneaminohydantoin (furagin) |
2 |
A |
3rd |
|
38 |
2-chloro-4,6-bisisopropylaminosimtriazine (propazine) |
5 |
A |
3rd |
|
39 |
10-hydrochloride-3-dimethyl-aminopropyl-2-chlorophenothiazine (aminazine / chlorpromazine)+ |
0,3 |
A |
2nd |
|
40 |
Chlortetracycline |
0,1 |
A |
2nd |
|
41 |
Zinc oxide |
5 |
A |
3rd |
|
42 |
Aerosil modified with butyl alcohol |
1 |
A |
3rd |
|
43 |
PLANT AND ANIMAL origin dust: containing over 10% silicon dioxide (bast, cotton, flax, wool, fluff, etc.) |
2 |
A |
4th |
|
44 |
Containing from 2 to 10% silicon dioxide |
4 |
A |
4th |
|
45 |
Containing less than 2% silicon dioxide (flour, cotton, wood dust, etc.) |
6 |
A |
4th |
|
46 |
Silicates and silicate-containing dust |
4 |
A |
4th |
Notes: A — aerosol, P — vapor, P + A — mixture of vapor and aerosol; * shift-average MAC values.
Table 6 Criteria for assessing microbial contamination of pharmacy indoor air
|
No. item |
Room name |
Working conditions |
Total colony count of microorganisms per 1 m3 of air |
Staphylococcus aureus count per 1 m3 of air |
|
|
1 |
Aseptic block, sterilization room (clean side) |
Before work |
Not exceeding 500 |
None in 250 L |
None in 250 L |
|
After work |
Not exceeding 1000 |
None in 250 L |
None in 250 L |
||
|
2 |
Assistant room, packaging room, defectoscopy room, supply room |
Before work |
Not exceeding 750 |
None in 250 L |
None in 250 L |
|
After work |
Not exceeding 1000 |
None in 250 L |
None in 250 L |
||
|
3 |
Washing room |
During work |
Not exceeding 1000 |
None in 250 L |
Up to 12 |
|
4 |
Customer service area |
During work |
Not exceeding 1500 |
Up to 100 |
Up to 20 |
Table 7 Classification of production premises by permissible content of microorganisms and particulate matter in the air for sterile product manufacturing (RD)
|
Cleanroom class |
Maximum permissible particle count per 1 m3 by size |
Maximum permissible viable microorganism count per 1 m3 of air |
Air exchange conditions in premises (exchange rate per hour) |
|
|
> 0.5 µm |
> 5 µm |
|||
|
1 |
3500 |
0 |
< 1 |
> 40 |
|
2 |
350,000 |
2000 |
50 |
20 - 40 |
|
3 |
3,500,000 |
20,000 |
100 |
> 10 |
|
4 |
According to GOST 12.1.005-88 |
|||
Table 8 Classification of premises for non-sterile drug manufacturing by maximum permissible particle and microorganism counts in the air
|
Cleanliness class |
Maximum permissible particle count per 1 m3 |
Maximum permissible viable microorganism count, CFU/m3 |
|
|
> 0.5 µm |
> 5 µm |
||
|
C |
350,000 |
2,000 |
100 |
|
D |
3,500,000 |
20,000 |
200 |
Table 9 Classification of production premises by permissible content of microorganisms and particulate matter in the air for sterile product manufacturing (RD)
|
Object name |
Disinfecting agent |
Disinfection regimen |
Treatment method |
||
|
Concentration, % |
Exposure time, min |
||||
|
Nominal value |
Extreme deviations |
||||
|
1 |
2 |
3 |
4 |
5 |
6 |
|
Premises, furnishings, equipment |
Chloramine B (OST 6-01-76-79); (TU 6-01-689387-33-90) |
1.00 |
Double wiping with a 15-min interval |
||
|
Chloramine B with 0.5% detergent |
0.75 |
-"- |
|||
|
Hydrogen peroxide (GOST 177-88) with 0.5% detergent |
3.00 |
-"- |
|||
|
Sulfochlorantine (TU 6-01-746-72) |
0.20 |
-"- |
|||
|
DP-2 (TU 6-57-14-89) |
0.10 |
-"- |
|||
|
Neutral calcium hypochlorite (GOST 2526-82) |
0.25 |
-"- |
|||
|
Rubber and |
Chloramine B |
0.25 |
30 |
+5 |
Complete immersion in the solution |
|
plastic |
Chloramine B with 0.5% detergent |
0.25 |
15 |
+5 |
-"- |
|
products |
Hydrogen peroxide |
3.00 |
30 |
+5 |
-"- |
|
Hydrogen peroxide with 0.5% detergent |
3.00 |
30 |
+5 |
-"- |
|
|
Sulfochlorantine Dezoxon-1 (TU 6-02-1283-84) |
0.10 0.025 |
30 |
+5 |
-"- |
|
|
Dezoxon-1 with 0.5% detergent |
0.01 |
30 |
+5 |
-"- |
|
|
Chlorhexidine bigluconate in 70% ethyl alcohol |
1.00 |
30 |
+5 |
-"- |
|
|
0.50 |
15 |
Complete immersion in the solution |
|||
|
pharmaceutical |
Chloricin |
Immersion in the solution |
|||
|
ware for |
1.0 |
120 |
(for heavily soiled |
||
|
drug manufacturing |
glassware) |
||||
|
medicines |
0.10 |
15 |
Complete immersion in the solution |
||
|
DP-2 |
0.20 |
120 |
Immersion in the solution (for heavily soiled glassware) |
||
|
Hydrogen peroxide with 0.5% detergent |
3.00 |
30 |
-"- |
||
|
Hydrogen peroxide |
3.00 |
30 |
Complete immersion in the solution |
||
|
Chloramine B |
1.0 |
30 |
-"- |
||
|
Spatulas, scissors, tweezers, other small metal items, as well as glassware |
Purified water (FS 42-2619-89) at boiling temperature 100 °C |
30 |
+5 |
Boiling with complete immersion of the item in water, in a lid-covered container |
|
|
Sodium bicarbonate (GOST 2156-76, GOST 4201-79) at boiling temperature 100 °C |
2.00 |
15 |
+5 |
Boiling with complete immersion of the item in the solution, in a lid-covered container |
|
|
Hand-washing brushes, rubber and foam Sponges |
Purified water at boiling temperature 100 °C |
15 |
+5 |
Boiling with complete immersion of the item in water, in a lid-covered container |
|
|
Sodium bicarbonate at boiling temperature 100 °C |
2.00 |
15 |
+5 |
Boiling with complete immersion of the item in the solution, in a lid-covered container |
|
|
Porous rubber mats |
Chloramine B with 0.5% detergent |
0.75 |
30 |
+5 |
Complete immersion in the solution |
|
Hydrogen peroxide with 0.5% detergent |
3.00 |
30 |
+5 |
||
|
Sulfochlorantine |
0.20 |
Double wiping with a 15-min interval |
|||
|
Chlorcin |
0.50 |
-"- |
|||
|
Neutral calcium hypochlorite |
0.50 |
-"- |
|||
|
DP-2 |
0.20 |
-"- |
|||
|
Foam rubber mats |
Purified water at boiling temperature 100 °C |
5 |
Boiling with complete immersion of the item in water, in a lid-covered container |
||
|
Hydrogen peroxide with 0.5% detergent |
3.00 |
30 |
+5 |
Complete immersion in the solution |
|
|
Cleaning equipment |
Chloramine B |
1.00 |
60 |
+5 |
Complete immersion in the solution |
|
Chlorcin |
1.00 |
120 |
+5 |
-"- |
|
|
Sulfochlorantine |
0.10 |
60 |
+5 |
-"- |
|
|
Neutral calcium hypochlorite |
1.00 |
120 |
+5 |
-"- |
|
|
Dezoxon-1 |
0.10 |
120 |
+5 |
-"- |
|
|
DP-2 |
0.20 |
120 |
+5 |
-"- |
|
|
Cleaning rags and wipes |
Purified water at boiling temperature 100 °C |
30 |
+5 |
Boiling after washing |
|
|
Sanitary and technical equipment (sinks, toilets, etc.) |
Chloramine B with 0.5% detergent |
0.75 |
Double wiping with a 15-min interval |
||
|
Chloramine B |
1.00 |
-"- |
|||
|
Neutral calcium hypochlorite |
0.50 |
-"- |
|||
|
Chlorcin |
0.50 |
-"- |
|||
|
DP-2 |
0.20 |
-"- |
|||
|
Cleaning and disinfecting agents: "Dezus", "Sanita", "Blesk-2", "PChD" and others |
0.50 g per 100 cm2 of surface |
After cleaning, wipe the surface with a damp cloth |
|||
|
Personnel hands |
Ethyl alcohol (GOST 5962-67) |
80.00 |
After washing with soap, wipe with a gauze pad moistened with the solution |
||
|
Chlorhexidine bigluconate in 70% ethyl alcohol |
0.50 |
5 |
-"- |
||
|
Chloramine B (used when other agents are unavailable) |
0.50 |
2 |
Immerse completely in the preparation solution and wash for the specified time, then wipe with a sterile gauze pad |
||
|
Personnel hands |
Formula C-4 |
2.4 |
1 |
-"- |
|
|
Iodopiron (VFS 42-2410-85) |
0.1 |
4 |
-"- |
||
|
Degmin (FS 42-1775-89) |
1.0 |
3 |
+3 |
Sequential wiping with two swabs generously moistened with the preparation solution for 3 min each |
|
|
Production footwear |
Chloramine B |
1.0 |
Double wiping with a 15-min interval |
||
|
Chloramine B with 0.5% detergent |
0.75 |
-"- |
|||
|
Hydrogen peroxide with 0.5% detergent |
3.0 |
-"- |
|||
|
Sulfochlorantine |
0.1 |
-"- |
|||
|
Formalin (GOST 1625-89) |
10.0 |
Place cotton wool soaked in a 10% formalin solution into the toe of the footwear, place the footwear in a plastic bag for 2 hours, and tie it tightly. Then remove the cotton wool and wipe the footwear with a 10% ammonia solution. |
|||
Table 10 Artificial lighting of pharmacy premises
|
Item No. |
Room |
Work surface illuminance, lx |
Light source |
Plane for which illuminance is standardized |
Permissible discomfort index |
Permissible ripple factor |
Room environmental characteristics |
Lamp type |
|
1 |
Visitor area in the customer service hall |
150 |
FL |
H 0.8 |
40 |
20 |
Normal |
LB, LTB |
|
2 |
Prescription department, finished drugs department, OTC sales, optics, pharmacy kiosk |
300 |
FL |
H 0.8 |
40 |
20 |
-"- |
LB, LTB |
|
3 |
Assistant room, aseptic room, analytical room, quality control and labeling room, packaging room, defectoscopy room |
500 |
FL |
H 0.8 |
40 |
10 |
-"- |
LD, LHB |
|
Distillation room, sterilization room, washing room |
150 |
IL |
Floor |
60 |
Humid |
LB |
||
|
5 |
Storage rooms for drugs, glassware, hygiene items, parapharmaceutical products |
150 |
FL |
V 1.0 |
-"- |
-"- |
Class 11-11a |
LB |
|
6 |
Storage rooms for flammable and combustible liquids, acids, disinfectants |
75 |
FL |
On shelves |
-"- |
-"- |
Chemical activity class 11-11a |
LB |
|
Container storage |
10 |
IL |
Floor |
Class 11-11a |
IL |
Notes: FL — fluorescent lamps, IL — incandescent lamps, H — horizontal plane, V — vertical plane, LB — white light lamps, LTB — warm-white light lamps, LD — daylight lamps, LHB — cool-white light lamps.
Table 11 Design temperatures and air exchange rates in pharmacy premises
|
Item No. |
Room |
Temperature, °C * |
Air exchange rate |
|
|
Supply |
Exhaust |
|||
|
1 |
Customer service hall ** |
18 |
3 |
4 |
|
2 |
Assistant room, analyst-provener room, defectoscopy room, packaging room, distillation room, rooms for storing and labeling injection drugs, goods storage rooms |
18 |
2 |
3 |
|
3 |
Aseptic room |
18 |
4 |
2 |
|
4 |
Sterilization room, herbal raw Materials supply room |
18 |
3 |
4 |
|
5 |
Storage rooms for thermolabile, dry, and liquid medications |
4 |
- |
3 |
|
6 |
Sterile products supply room |
18 |
3 |
- |
* For pharmacies located in the IV construction and climatic region, during the warm season, the design air temperature in premises equipped with air conditioning systems should be set 3 °C higher than indicated in the table. ** Temperature reduction down to 16 °C is permitted only during the cold season.
Table 12 State Sanitary Rules and Regulations "Drinking Water. Hygienic Requirements for the Quality of Centralized Household and Drinking Water Supply" (SanPiN) Order of the Ministry of Health of Ukraine No. 383 dated December 23, 1996.
1. Microbiological safety indicators of drinking water
|
Item No. |
Parameter |
Unit of measurement |
Standard limits |
|
1 |
Total bacterial count per 1 cm3 of water (total plate count - TPC) |
Colony-forming units (microorganisms), CFU/cm3 |
Max. 100 |
|
2 |
Coliform Bacteria count per 1 dm3 (coliform index) |
-"- |
Max. 3 |
|
3 |
Thermotolerant coliform bacteria count (fecal coliform index) per 100 cm3 |
-"- |
Absent |
|
4 |
Pathogenic microorganisms count per 1 dm3 |
Absent |
|
|
5 |
Coliphages count per 1 dm3 |
Plaque-forming units (PFU/dm3) |
Absent |
|
6 |
Parasitological parameters: a) pathogenic intestinal Protozoa count per 25 dm3; b) intestinal helminths count per 25 dm3 of water |
Cells, cysts per 25 dm3 Cells, eggs, larvae per 25 dm3 |
Absent Absent |
2. Radiation safety indicators of drinking water
|
Item No. |
Parameter |
Unit of measurement |
Standard limits |
|
1 |
Total alpha activity concentration |
Bq*/dm3 |
0,1 |
|
2 |
Total beta activity concentration |
Bq/dm3 |
1,0 |
* Becquerel
3. Organoleptic parameters of drinking water quality
|
Item No. |
Parameter |
Unit of measurement |
Standard limits, max. |
Safety class |
|
1 |
Odour |
TON* |
2 |
- |
|
2 |
Turbidity |
NTU** |
0,5 (1,5) *** |
- |
|
3 |
Colour |
Degrees |
20 (35) |
— |
|
4 |
Taste |
TON |
2 |
— |
|
5 |
Hydrogen ion concentration, pH range |
Units |
6,5-8,5 |
— |
|
6 |
Total mineralization (dry residue) |
mg/dm3 |
1000 (1500) |
— |
|
7 |
Total hardness |
mg-eq/dm3 |
7(10) |
— |
|
8 |
Sulfates |
mg/dm3 |
250 (500) |
4 |
|
9 |
Chlorides |
mg/dm3 |
250 (350) |
4 |
|
10 |
Copper |
mg/dm3 |
1,0 |
3 |
|
11 |
Manganese |
mg/dm3 |
0,1 |
3 |
|
12 |
Iron |
mg/dm3 |
0,3 |
3 |
|
13 |
Chlorophenols |
mg/dm3 |
0,0003 |
4 |
* Threshold odour number (until odour and taste disappear).
** Nephelometric turbidity units.
*** Values in parentheses are permitted depending on the specific local situation.
Note: water must not contain components capable of altering organoleptic properties, such as zinc, Surfactants, petroleum products, or phenols, at concentrations detectable by standard Analytical Methods.
4. Indicators of physiological adequacy of the mineral composition of water
|
Item No. |
Indicator |
Unit of measurement |
Standards |
|
1 |
Total mineralization |
mg/dm3 |
Min. 100.0, max. 1000.0 |
|
2 |
Total hardness |
mEq/dm3 |
Min. 1.5, max. 7.0 |
|
3 |
Magnesium |
mEq/dm3 |
Min. 10.0, max. 80.0 |
|
4 |
Fluoride |
mEq/dm3 |
Min. 0.7, max. 1.5 |
|
5 |
Total alkalinity |
mEq/dm3 |
Min. 0.5, max. 6.5 |
5. Toxicological indicators of the safety of The chemical composition of drinking water
|
Item No. |
Indicators |
Unit of measurement |
Standards, max. |
Hazard class |
|
1 |
Aluminum |
mg/dm3 |
0.2(0.5)* ** |
2 |
|
2 |
Barium |
mg/dm3 |
0.1 |
2 |
|
3 |
Arsenic |
mg/dm3 |
0.01 |
2 |
|
4 |
Selenium |
mg/dm3 |
0.01 |
2 |
|
5 |
Lead |
mg/dm3 |
0.01 |
2 |
|
6 |
Nickel |
mg/dm3 |
0.1 |
3 |
|
7 |
Nitrates |
mg/dm3 |
45.0 |
3 |
|
8 |
Fluoride |
mg/dm3 |
1.5 |
3 |
|
b) Organic components: |
||||
|
1 |
Trihalomethanes (THMs, total) |
mg/dm3 |
0.1 |
2 |
|
2 |
Chloroform |
mg/dm3 |
0.06 |
2 |
|
3 |
Dibromochloromethane |
mg/dm3 |
0.01 |
2 |
|
4 |
Carbon tetrachloride |
mg/dm3 |
0.002 |
2 |
|
5 |
Pesticides (total) |
mg/dm3 |
0.0001 |
** |
|
c) Integral indicators: |
||||
|
1 |
Permanganate oxidizability (KMnO4) |
mg/dm3 |
4.0 |
— |
|
2 |
Total organic carbon |
mg/dm3 |
3.0 |
— |
* The value indicated in parentheses is permissible when treating water with aluminum-containing Reagents.
** The list of pesticides is determined taking into account the specific situation. Water must not contain toxic components such as mercury, cadmium, nitrites, cyanides, chromium (+6), 1,1-dichloroethylene, 1,2-dichloroethane, and benzopyrene at concentrations detectable by standard Research Methods.
Table 13 Safety indicators for drinking water from decentralized sources
|
No. item |
Indicator |
Standards |
|
1 |
Transparency |
At least 30 cm |
|
2 |
Coloration |
Not more than 400 |
|
3 |
Odor and taste |
3 points |
|
4 |
Total hardness |
Up to 14 mmol/L |
|
5 |
Fluoride |
Up to 1.5 mg/L |
|
6 |
Nitrates |
Up to 10 mg/L |
|
7 |
Nitrites |
Up to 0.002 mg/L |
|
8 |
Ammonia |
Up to 0.1 mg/L |
|
9 |
Chlorides |
20 - 30 mg/L |
|
10 |
Oxidizability |
Up to 4 mg/L |
|
11 |
Microbial count |
Up to 300 - 400 per 1 mL |
|
12 |
Coli-titer |
At least 100 |
|
13 |
Coli-index |
Not more than 10 |
Table 14 Physiological nutritional standards for the able-bodied adult population
|
Groups of physical activity |
Gender |
Age groups |
Energy value, kJ (kcal) |
Proteins, including animal proteins, g |
Fats, g |
Carbo hydrates, g |
Vitamins, mg |
||||
|
thiamin (B1) |
riboflavin (B2) |
pyridoxine (B6) |
ascorbic acid (C) |
niacin (PP) |
|||||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
|
I |
M. |
18-29 |
11 723 (2800) |
91(50) |
103 |
378 |
1,7 |
2,0 |
2,0 |
70 |
18 |
|
30-39 |
11 304 (2700) |
88(48) |
99 |
365 |
1,6 |
1,9 |
1,9 |
68 |
18 |
||
|
40-59 |
10 676 (2550) |
83(46) |
93 |
344 |
1,5 |
1,8 |
1,8 |
64 |
17 |
||
|
F. |
18-29 |
10 048 (2400) |
78(43) |
88 |
324 |
1,4 |
1,7 |
1,7 |
60 |
16 |
|
|
30-39 |
9630 (2300) |
75 (41) |
84 |
310 |
1,4 |
1,6 |
1,6 |
58 |
15 |
||
|
40-59 |
9210 (2200) |
72 (40) |
81 |
297 |
1,7 |
1,9 |
1,9 |
69 |
18 |
||
|
II |
M. |
18-29 |
12 560 (3000) |
90 (49) |
110 |
412 |
1,8 |
2,1 |
2,1 |
75 |
20 |
|
30-39 |
12 142 (2900) |
87 (48) |
106 |
399 |
1,7 |
2,0 |
2,0 |
72 |
19 |
||
|
40-59 |
11 514 (2750) |
82 (45) |
101 |
378 |
1,7 |
1,9 |
1,9 |
69 |
18 |
||
|
F. |
18-29 |
10 676 (2550) |
77 (42) |
93 |
351 |
1,5 |
1,8 |
1,8 |
64 |
17 |
|
|
30-39 |
10 257 (2450) |
74 (41) |
90 |
337 |
1,5 |
1,7 |
1,7 |
61 |
16 |
||
|
40-59 |
9839 (2350) |
70 (39) |
86 |
323 |
1,4 |
1,6 |
1,6 |
59 |
15 |
||
|
III |
M. |
18-29 |
13 398 (3200) |
96 (53) |
117 |
440 |
1,9 |
2,2 |
2,2 |
80 |
21 |
|
30-39 |
12 979 (3100) |
93 (51) |
114 |
426 |
1,9 |
2,2 |
2,2 |
78 |
20 |
||
|
40-59 |
12 351 (2950) |
88 (48) |
108 |
406 |
1,8 |
2,1 |
2,1 |
74 |
19 |
||
|
F. |
18-29 |
11 304 (2700) |
81 (45) |
99 |
371 |
1,6 |
1,9 |
1,9 |
68 |
18 |
|
|
30-39 |
108 886 (2600) |
78 (43) |
95 |
358 |
1,6 |
1,8 |
1,8 |
65 |
17 |
||
|
40-59 |
10 467 (2500) |
75 (41) |
92 |
344 |
1,5 |
1,8 |
1,8 |
62 |
16 |
||
|
IV |
M. |
18-29 |
15 495 (3700) |
102 (56) |
136 |
518 |
2,2 |
2,6 |
2,6 |
92 |
24 |
|
30-39 |
15 072 (3600) |
99 (54) |
132 |
504 |
2,2 |
2,5 |
2,5 |
90 |
23 |
||
|
40-59 |
14 444 (3450) |
95 (52) |
126 |
483 |
2,1 |
2,4 |
2,4 |
86 |
22 |
||
|
F. |
18-29 |
13 188 (3150) |
87 (48) |
116 |
441 |
1,9 |
1,9 |
2,2 |
79 |
20 |
|
|
30-39 |
12 670 (3050) |
84 (46) |
112 |
427 |
1,8 |
2,1 |
2,1 |
76 |
20 |
||
|
40-59 |
12 142 (2900) |
80 (44) |
106 |
406 |
1,7 |
2,0 |
2,6 |
73 |
19 |
||
|
V |
M. |
18-29 |
18 008 (4300) |
118(65) |
158 |
602 |
2,6 |
3,0 |
3,0 |
108 |
28 |
|
30-39 |
17166(4100) |
113(62) |
150 |
574 |
2,5 |
2,9 |
2,9 |
102 |
27 |
||
|
40-59 |
16 328 (3900) |
107 (59) |
143 |
546 |
2,3 |
2,7 |
2,7 |
98 |
25 |
||
Note: Regardless of the labor intensity group, the established physiological norms for mineral salts are: Ca – 800 g; P – 1200 g.
Table 15 Chemical Composition and ENERGY VALUE OF food products
|
Food products |
Quantity, g |
Chemical composition |
Energy value, kcal |
||
|
Proteins |
Fats |
||||
|
1 |
2 |
3 |
4 |
5 |
6 |
|
Bread and bakery products: |
|||||
|
Rye bread |
100 |
6.9 |
0.9 |
42.9 |
217 |
|
Wheat bread |
100 |
8.1 |
0.9 |
47.0 |
234.2 |
|
City roll |
100 |
7.7 |
2.5 |
49.0 |
259.4 |
|
Plain bread rolls |
100 |
7.8 |
1.0 |
51.9 |
236 |
|
Sweet roll with jam |
75 |
4.3 |
8.9 |
41.8 |
271 |
|
Salads and vinaigrettes: |
|||||
|
Green salad with tomatoes and cucumbers |
120/20 |
20 |
8.5 |
4.1 |
105 |
|
Radish salad with sour cream |
120/30 |
4.4 |
10.9 |
5.0 |
140 |
|
White cabbage salad |
95/5 |
1.0 |
4.7 |
8.9 |
84.6 |
|
Vinaigrette with green onions |
90/10 |
1.0 |
2.4 |
7.4 |
57.3 |
|
Herring with garnish |
50/25 |
11.0 |
14.3 |
13.5 |
233 |
|
Sandwich ingredients: |
|||||
|
Dutch cheese |
100 |
23.5 |
30.9 |
- |
380 |
|
Processed cheese |
100 |
20.5 |
20 |
- |
271 |
|
Mayonnaise |
100 |
3.1 |
67 |
2.6 |
627 |
|
Lyubytelska sausage |
100 |
12.2 |
28 |
- |
301 |
|
Molochna sausage |
100 |
11.7 |
22.8 |
- |
252 |
|
Krakivska sausage |
100 |
15.6 |
35.2 |
- |
392.3 |
|
Eggplant caviar |
100 |
1.7 |
13.0 |
7.5 |
158.6 |
|
Butter |
100 |
1.0 |
87.5 |
0.6 |
787.5 |
|
First courses: |
|||||
|
Fresh cabbage borscht |
500 |
3.8 |
12.4 |
24.2 |
230 |
|
Sauerkraut soup (kapustnyak) |
500 |
3.2 |
13.4 |
21.9 |
218 |
|
Milk soups |
500 |
15.2 |
16.6 |
48.9 |
412 |
|
Meat okroshka |
500 |
20.5 |
18.8 |
24.6 |
360 |
|
Meat dishes: |
|||||
|
Natural cutlets |
40 |
19.2 |
24.8 |
- |
310 |
|
Homestyle cutlets |
40 |
5.0 |
7.1 |
1.4 |
92 |
|
Beef goulash |
100 |
24.3 |
23.6 |
6.8 |
347 |
|
Braised Liver |
100 |
18.4 |
10.5 |
13.7 |
229 |
|
Boiled meat: beef |
100 |
23 |
11 |
- |
201 |
|
mutton |
100 |
18.9 |
17.9 |
- |
244 |
|
Fried beef escalope |
75 |
19.9 |
26.2 |
- |
331 |
|
Cabbage rolls stuffed with meat and rice |
305/100 |
28.1 |
28.2 |
25.8 |
489 |
|
Beefsteak |
75 |
22.6 |
17.5 |
- |
253 |
|
Beef rissoles (batky) |
115/175 |
19.2 |
18.3 |
20.4 |
332 |
|
Roast duck |
100 |
18.1 |
22.6 |
- |
285 |
|
Milk sausages |
100 |
12.3 |
25.3 |
- |
277 |
|
Pork frankfurters |
100 |
10.1 |
31.6 |
- |
332 |
|
Boiled dumplings (pelmeni) |
100/10 |
21.6 |
17.7 |
41.3 |
428 |
|
Crepes with meat |
250/10 |
39.9 |
43.2 |
65.8 |
235 |
|
Fish dishes: |
|||||
|
Boiled fish (pike-perch, pike) |
100 |
15.7 |
0.6 |
- |
16 |
|
Fried fish |
100 |
193/17 |
0.7/0.8 |
- |
60/78 |
|
Fish meatballs in sauce |
100/100 |
16 |
12.3 |
17.7 |
253 |
|
Herring |
100 |
17 |
8.5 |
11.5 |
145 |
|
Hot-smoked cod |
100 |
26 |
1.2 |
2.7 |
115 |
|
Cold-smoked mackerel |
100 |
23.4 |
6.4 |
9.9 |
151 |
|
Gobies in tomato sauce |
100 |
12.8 |
8.4 |
5.2 |
145 |
|
Sprats |
100 |
17.4 |
32.4 |
0.4 |
364 |
|
Chum salmon granular caviar |
100 |
31.6 |
13.8 |
- |
250.6 |
|
Sturgeon caviar |
100 |
36.0 |
13.8 |
- |
235.8 |
|
Sea kelp (kelp) |
100 |
0.9 |
0.2 |
- |
5 |
|
"Ocean" krill paste |
100 |
18.9 |
6.8 |
- |
137 |
|
Side dishes: |
|||||
|
Buckwheat porridge |
200/10 |
8.4 |
9.3 |
60.9 |
371 |
|
Boiled rice |
200/10 |
4.8 |
7.8 |
53.9 |
314 |
|
Pasta |
200/10 |
7.5 |
7.8 |
57.9 |
337 |
|
Boiled potatoes |
250/10 |
2.9 |
7.1 |
39 |
239 |
|
Fried potatoes |
250/10 |
4.4 |
30.6 |
58.9 |
544 |
|
Braised cabbage |
200/10 |
4.0 |
8.5 |
21.4 |
189 |
|
Porridges: |
|||||
|
Rice porridge |
200/10 |
4.7 |
7.8 |
52.4 |
306 |
|
Semolina porridge |
200/10 |
9.5 |
7.9 |
56.0 |
334 |
|
Milk and dairy products: |
|||||
|
Whole cow's milk |
100 |
3.3 |
3.7 |
4.7 |
67 |
|
Skimmed milk |
100 |
3 |
0.05 |
4.7 |
31 |
|
Heavy cream (20% fat) |
100 |
2.8 |
20.0 |
3.8 |
213 |
|
Sour cream (25% fat) |
100 |
2.6 |
25 |
2.7 |
248 |
|
Whole kefir |
100 |
2.8 |
3.2 |
4.1 |
59 |
|
Skimmed kefir |
100 |
18 |
0.6 |
1.5 |
86 |
|
Cottage cheese (20% fat) |
100 |
14 |
18 |
1.3 |
226 |
|
Low-fat cottage cheese |
100 |
18 |
0.6 |
1.5 |
86 |
|
Crepes with cottage cheese and sour cream |
100/30 |
25.5 |
33.1 |
55.2 |
646 |
|
Pancakes with sour cream |
150/20 |
11.8 |
19.1 |
62.6 |
482 |
|
Sweet cheese dumplings (varenyky) |
200/30 |
21.2 |
21.9 |
50.5 |
497 |
|
Dairy ice cream |
100 |
3.5 |
3.5 |
22.2 |
137 |
|
Plombir ice cream |
100 |
3.2 |
15.4 |
19.7 |
234 |
|
Egg dishes: |
|||||
|
Boiled eggs |
2 pcs. |
10.3 |
9.8 |
0.4 |
135 |
|
Fried eggs (sunny-side up) |
120 |
15.5 |
22.6 |
0.7 |
227 |
|
Plain omelet |
170/5 |
17.0 |
28.2 |
2.7 |
343 |
|
Fried eggs with sausage |
175 |
15.9 |
24.9 |
10 |
301 |
|
Beverages and desserts: |
|||||
|
Black tea with sugar |
200 |
- |
- |
14.9 |
61 |
|
Coffee with milk |
200 |
2.5 |
2.6 |
28.0 |
150 |
|
Compote: from fresh berries |
200 |
0.4 |
- |
36.4 |
150 |
|
from canned fruits |
200 |
- |
- |
32.5 |
135 |
|
Berry kissel (starch-thickened drink) |
200 |
0.3 |
- |
34.7 |
143 |
|
Cocoa |
200 |
3.4 |
5.7 |
32.8 |
208 |
|
Fruits, berries, and vegetables: |
|||||
|
Apples |
100 |
0.3 |
- |
10 |
44 |
|
Pears |
100 |
0.4 |
- |
9.6 |
48 |
|
Grapes |
100 |
0.4 |
- |
14.3 |
66 |
|
Banana |
100 |
1.5 |
0.15 |
22.4 |
91 |
|
Oranges |
100 |
0.9 |
- |
8.4 |
38 |
|
Apricots |
100 |
0.9 |
- |
10.5 |
46 |
|
Cherries |
100 |
0.8 |
- |
11.3 |
49 |
|
Pumpkin |
100 |
0.7 |
- |
9.2 |
38 |
|
Melons |
100 |
0.6 |
- |
9.6 |
39 |
|
Beetroot |
100 |
1.7 |
- |
10.8 |
28 |
|
Tomatoes |
100 |
0.6 |
- |
0.1 |
19 |
|
Eggplants |
100 |
0.6 |
5.5 |
24 |
|
|
Pickled cucumbers |
100 |
2.8 |
- |
1.3 |
19 |
|
Confectionery: |
|||||
|
Caramel candies |
100 |
tr. |
0.1 |
95.7 |
362 |
|
Chocolate |
100 |
5.4 |
35.3 |
52.6 |
540 |
|
Sponge cake |
100 |
4.7 |
9.3 |
64.2 |
344 |
|
Natural honey |
100 |
0.8 |
- |
80.3 |
308 |
Table 16. Composition and area of pharmacy premises
|
Premises |
Pharmacy authorized for retail sale of medicinal products and medical devices |
Pharmacy authorized for compounding non-sterile dosage forms and retail sale of medicinal products and medical devices, m2 |
Pharmacy authorized for aseptic compounding and retail sale of medicinal products and medical devices, m2 |
|
1 |
2 |
3 |
4 |
|
1. Customer service area |
20 |
20 |
20 |
|
2. Premises for compounding non-sterile dosage forms: |
|||
|
a) dispensary room 1 |
- |
20 |
20 |
|
b) packaging room |
- |
8 |
8 |
|
c) analytical pharmacist's office |
- |
8 |
8 |
|
d) washing room 2 |
- |
8 |
8 |
|
e) pharmacy glassware sterilization room |
- |
8 |
8 |
|
f) purified water production room |
- |
8 |
8 |
|
3. Premises for aseptic drug compounding (aseptic unit): |
|||
|
a) aseptic room with an airlock |
- |
- |
8+2 |
|
b) defectoscopy room with an airlock |
- |
- |
10+3 |
|
c) drug sterilization room |
- |
- |
10 |
|
d) quality control and labeling room |
- |
- |
10 |
|
e) water for injection production room |
- |
- |
9 |
|
f) analytical pharmacist's office |
- |
- |
8 |
|
4. Storage premises for medicinal products and medical devices: |
|||
|
a) storage room for medicinal products |
15 |
15 |
15 |
|
b) storage room for flammable and combustible liquids |
4 |
4 |
4 |
|
c) storage room 3 for Sanitary and hygienic supplies and medical devices |
6 |
6 |
6 |
|
d) storage room for auxiliary materials and containers |
- |
8 |
8 |
|
e) storage room for herbal medicinal raw materials |
4 |
4 |
4 |
|
5. Administrative and utility premises: |
|||
|
a) manager's office 4 |
8 |
10 |
10 |
|
b) accounting office |
8 |
10 |
10 |
|
c) staff room 5 |
8 |
12 |
12 |
|
d) locker room |
8 |
12 |
12 |
|
e) cleaning equipment storage room |
2 |
2 |
2 |
|
f) restroom |
3 |
3 |
3 |
Note: pharmacies with minimum floor space are permitted to combine:
1) the dispensary room with the packaging room;
2) the washing room with the pharmacy glassware sterilization room;
3) the storage room for sanitary and hygienic items and medical devices with the storage room for auxiliary materials and containers;
4) the manager's office with the accounting office;
5) the staff room with the locker room.
Table 17. Composition and area of premises for a drug quality control laboratory
|
Premises |
Area, m2 |
||
|
Categories by workload |
|||
|
I |
II |
III |
|
|
Analytical laboratory hall |
63 |
31 |
25 |
|
Weighing room |
15 |
15 |
- |
|
Optical room |
12 |
- |
- |
|
Reagent storage room |
9 |
- |
- |
|
Bacteriological analysis room |
8 |
- |
- |
|
Methodology room |
12 |
8 |
- |
|
Manager's office and administrative room |
14 |
8 |
8 |
|
Restroom |
2 |
2 |
1 |
|
Shower room |
2 |
- |
- |
|
Basement (flammable reagent room) |
7 |
- |
- |
|
Basement for biological materials |
7 |
- |
- |
|
Washing room |
17 |
10 |
1 |
Last update: 08/08/2026
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