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

Hydrochloric acid

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

Mould and Yeast Fungi 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

-"-

Glass


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

a) Inorganic Components:

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

CARBOHYDRATES

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



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