Alchemist

[Alchemist]

Yes, it can be and below is the recipe

Equipment:
1 mL TB syringe Quantity: 2

Procedure:
1. Remove 0.15 mL from tears naturalle II 15 mL bottle
2. Using 1 mL TB syringe withdraw 0.15 mL from Atropnie 1% and add to tears naturale II bottle
3. Slowly draw up tears natural from bottle into same syring to rinse Atropine into bottle
4. Replace the cap and label

Storage: Refrigerate
Expiration: 14 days

References:
Dr. Paul Rychwaslski
Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5 %, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2) https://www.sciencedirect.com/science/article/abs/pii/S0161642011006853

[Alchemist]

I am not clear what you want to know based on your question. Your cleanroom is not sterile. You cant’ sterility test your room. You are working in an environment with an acceptable low level of contamination and using tryptic soy agar will allow you to test the air and surfaces for the presence of microorganisms. If you want to sterility test a CSP, you will use two different media. A number of articles have been written on this subject and can be found on the CriticalPoint website under resources, Pearls or in Pharmacy, Purchasing and Products Magazine, http://www.pppmag.com. Hope this helps.

[Alchemist]

Below are the ingredients and the procedure

Suggested ingredients:

• Phenol crystals……………………………..1.2 g
• Ethanol 95% ………………………………..1.00 mL
• Sterile water for injection USP ………29.00 mL

Supplies:

• Empty sterile vials: 30 mL
• Syringes: 30 mL, 5 mL, 3 mL
• Sterile 0.22 micron filter (stable in phenol, eg, Acrodisc syringe filter with PTFE membrane)
• Needles: 18 ga, 20 ga
• Glass beaker

Suggested procedure:

1. Weigh 1.2 gm phenol, place into the beaker.
2. Add 1.0 mL Ethanol 95% to (1) and allow phenol to dissolve.
3. Add 29 mL sterile water for injection (SWFI) to (2) with stirring.
4. Pass mL Ethanol 95% through the filter to wet it, then flush with 5 mL SWFI.
5. Draw phenol mixture in (3) into 30 mL syringe, add filter from (4),and add 20 ga needle.
6. Prepare 30 mL empty sterile vial: wipe stopper with alcohol; insert 20 ga needle as air vent.
7. Inject phenol solution into vial in (6). Remove needles and seal as desired.
8. Label.
9. Perform the bubble point filter integrity test

Precautions: Phenol is corrosive; steps 1 to 3 could be performed in a fume hood and the process moved into the cleanroom at step 4.

Reference:

http://www.pharmacytimes.com

[Alchemist]

I have attached a concept plan that might answer many of your questions. Let me know if this helps.

https://mega.nz/file/zp53GY4S#1JvIS9BRXE8uso99UuYloVfTz8MvqLnvPR5yaQ0R5Kw

[Alchemist]

First try this relevant topic

How to Prepare Intravitreal Antibiotic Eyedrops

Answering your question:
In making the topical solution of fortified ceftazidime 50mg/mL you can use either SWFI or BSS (balanced salt solution) or normal saline. Many compounding formulas you will find use either of these, most common is normal saline or BSS though (helps to be more isotonic with the eye). Attached are 2 publications for the stability you are seeking. These are for 24 hour room temp, 7 days fridge. Of note, this is also the same ceftazidime stability for the parenteral dilutions. I have included another nice reference for many ophthalmic drug dilutions to many routes, intravitreal, intracameral, intraoccular.

For others not familiar with *fortified* ophthalmic drops here is a nice description below.
These are usually used in endophalmitis (inflammation/infection of the cornea and inner eye)

Fortified preparations of ophthalmic antibiotics are made with commercially available antibiotics (parenteral or lyophilized preparations). These fortified eyedrops have two main advantages: the increase in the antibiotic concentration in the corneal stroma and the wide choice of available antibiotics. Fortified ophthalmic solutions are used in severe keratitis (large diameter, stroma infiltration, inflammation of the anterior chamber, old patient). The following associations are recommended: ticarcillin+gentamicin+vancomycin or cephazolin+amikacin since they provide a broad-spectrum antibiotic activity against the wide range of bacteria that may cause keratitis. The main toxicity of these preparations is the retardation effect of the epithelial-healing rate (aminoglycosides, vancomycin) and the corneal and conjunctival toxic effects (aminoglycosides). However, fortified antibiotic drops remain the standard therapy for severe bacterial keratitis, given their corneal penetration and the possibility of the synergic and combined effect of an antibiotic association.

https://mega.nz/file/e9oghIoQ#szSXieds2qcNudxDwyCY-PsvTnulYlbfe0YQL-OwrEs

https://mega.nz/file/u9xgwIQY#HqHOd-u596yaDeUPYx7X5qJ1YleiRr_YwtnHMUlryAE

[Alchemist]

Thank you so much Rachel for your important conclusion on the impact of siting of refrigerators within ISO classified areas. Sometimes the balance between facts and speculations is a tough game and in such instances nothing beats objective, published evidence.

I would like to mention one aspect which although not necessarily related to refrigerator function per se can also be indirectly linked to such devices. Refrigerator door gaskets can be breeding grounds for microbiological growth, especially fungi (especially if gaskets are black in colour – hard to detect) – so a robust cleaning and disinfection programme that takes this into account would be essential. This is especially important if the refrigerator is used to store vials for aseptic manipulation (any contamination picked up during opening can compromise transfer disinfection of such vials).

Also as Rachel said, siting of refrigerators close to low-floor extracts is also very important as any potential contaminants (including viable particles) will be sucked in and safely extracted without risk of being pushed to areas around the room with the turbulent air-flows. Such siting would therefore also work as a ‘risk containing’ mechanism for such eventualities.

[Alchemist]

My advice is to use a dosing diagram. It’s a standardized table that shows the standard dilution, e.g. 1mg in 10ml (100mcg/ml); and the equivalent volume to a series of weights. You can approximate to the nearest weight. As per your example, a dose for a 4kg baby would be (0.04mg) which is equivalent to (0.4ml) of the diluted solution.
This strategy is suggested as a safety issue against the wrong dose calculation associated with preparation. You can find an example of such tables under (Anaphylactic Shock) topic in uptodate. Such tables are to be placed in the anaphylactic trays.

* Another option is to use the ready to use syringes of (0.15mg and 0.3mg) as per the weight ranges indicated:-

EpiPen Jr: IM, SubQ: Children 15 to 29 kg: 0.15 mg; if anaphylactic symptoms persist, dose may be repeated using an additional EpiPen Jr

EpiPen: IM, SubQ: Children ≥30 kg: 0.3 mg; if anaphylactic symptoms persist, dose may be repeated using an additional EpiPen

Finally, as of May,1 2016, ratio expression of epinephrine, e.g 1:1000, is prohibited by ISMP due to associated latent errors.
It’s advised to use (mg) for expression of doses.

[Alchemist]

I thought you would be interested to read the recent ASPEN tutorial for Adult PN, include:
1-Determination of energy and volume requirements
2-Macronutrient content
3-Micronutrient content
4-PN for special situations
5-Daily monitoring and adjustment of PN formula
6-Complications

https://mega.nz/file/fxYn1CSA#SNyKzov2EeyGIV_R16o0aWwsXqIgP3HS0WiBoxXhF1c

[Alchemist]

To provide a recommendation on proper electrolytes management a more information needed. However, generally managing electrolytes in PN is an art rather than a science. The quantity of electrolytes which should be added to PN is determined by several factors:

1. The existence of abnormal sources of electrolyte loss e.g. Diarrhea, nasogastric suction, fistula

2. Renal function

3. Medication profile (don’t forget IV fluids) e.g. Chronic use of PPI =hypomagnesemia

4. Nutrition history

5. Past medical and surgical histories

Remember:

· More dextrose = more electrolytes

· Potassium affected by acid base base disorder (if acidosis exist use acetate) and potassium affected by magnesium level

· Sodium level affected by fluid status

[Alchemist]

Thank you for sharing these superb insights. I want to add my “ditto” here.

My microbiologist thought partner explained to me that after we spray our “disinfectant” liquids and they dry, many such commercial products leave a residue of organic compounds behind. It will be in a visible “crust” unless removed by (sterile) water or (sterile) alcohol – or better yet – sterile water allowed to thoroughly dry, followed by sterile alcohol allowed to thoroughly dry. He explained that the residual of disinfectants can be thought of as “germ food.”

You are correct in saying that we should never intentionally spray anything toward the delicate wonder that is our HEPA filter. Microbes of all variety and stages are ready to spring to life as soon as they are presented with the right conditions of oxygen, water (they’re microscopic by definition, so humidity matters), and organic nutrients. That’s why we call them, “germs.”

The every action and activity of every qualified operator relative to our equipment and environment should reflect this awareness. Training is absolutely key and must be universal and comprehensive.

[Alchemist]

We suggest validation every 6 months, even if it is not operated.
This will prevent any surprises before you go live.

Check this topic STARTING PN FROM A-Z

[Alchemist]

For the preparation of Non-Hazardous Drugs, the buffer room needs to be at a higher pressure than the ante-area, which, in turn, must be at a higher pressure than the surrounding areas.

This is to ensure outward flow of the (at least) ISO Class 7 air of the buffer room to the (at least) ISO Class 8 air of the ante-area and in turn to the surrounding areas whenever doors or pass-throughs are opened.

USP <797> states, “a minimum positive pressure of 0.02- to 0.05-inch water column is required,” for rooms with a physical separation of ante area from buffer area by means of walls, doors, and pass-throughs.

By mechanical control or through your SOPs and staff training, you should ensure that doors from the buffer room to the ante-area and doors from that ante-area to the outside environment are never open at the same time.

Ante room pressures for Hazardous Drug compounding have become more complex and detailed with the publication of USP <800>.

Under <800>, the (at least) ISO Class 7 buffer room (C-SEC) must operate at a negative pressure between 0.01- and 0.03-inches of water column relative to the ante-area. This means that for HD sterile compounding the ante-area air must be as clean as the buffer room air, because when the door between the rooms is opened, air will move from the ante-area toward the buffer area. Therefore, the ante-area must also maintain no worse than ISO Class 7 quality under dynamic conditions.

Additionally, in an <800> cleanroom design, the ISO Class 7 ante-room must become a barrier to the movement of dirty air from the outside environment toward the Direct Compounding Area (DCA). This is achieved by ensuring that the ante-area maintains at least 0.02-inch water column of positive pressure relative to adjacent unclassified areas.

View post on imgur.com

View post on imgur.com

As must always be emphasized, even the best-designed cleanroom environment cannot protect our patients from a careless operator. As noted in <797>, “direct touch contamination is the most likely source of introducing microorganisms into CSPs prepared by humans.”

My advice – and this is over and above USP requirements – is that you ensure one extra “layer” of cleanliness by surrounding the buffer room AND the ante-area with what I call a “work room” or a “prep room” that has HEPA-filtered air supply, smooth, impervious surfaces (floors, walls, ceilings, shelves, and fixtures), minimal particulate-shedding contents (i.e., no cardboard, no wood, no pressed board, etc.) minimal paper, and a strict cleaning protocol. I don’t suggest that you attempt to qualify the air in this outer room, but it seems clear to me that you don’t really want it at ISO Class 9 (outside world) either. I refer many of my clients to a firm that has mastered this strategy and these rooms typically outperform others.

I’m very weary of seeing my hospital clients waste their precious capital budgets on poorly-designed cleanrooms that are obsolete before they’re even opened because their architects and construction partners don’t understand the multitude of intricate requirements.

All of the above are my personal interpretations. If I stated anything incorrectly, I urge you to reply, as it’s the only way for us all to learn. These are complex concepts and I try to improve my understanding every day.

Best regards,

[Alchemist]

Please find attached below the PIL for the Humulinru100 , it can be given either by Subcutaneous or IV routes .

http://uspl.lilly.com/humulinru100/humulinru100.html

[Alchemist]

To be able to answer your question better, could you please elaborate on what exactly it is that you need for epinephrine infusion in pediatrics? are you after just simple and standard IV administration information or are you after a specific policy/guideline for its administration with respect to a particular indication e.g. anaphylaxis, cardiac arrest etc

Regards

[Alchemist]

First of all, I recommend to review the BPS website that has lots of info about the certification and how to apply and prepare for the exam. (website link: http://www.bpsweb.org).

[Author]

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